Document text
Page 1 of 2 UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF TEXAS
PUBLIC HEALTH AND MEDICAL
PROFESSIONALS FOR TRANSPARENCY,
P
laintiff,
-against -
F
OOD AND DRUG ADMINISTRATION,
D
efendant. C
ivil Action No. 4:21- cv-01058-P
APPENDIX IN SUPPORT OF PLAINTIFF’S OPPOSITION TO FDA’S REQUEST FOR
AT LEAST 75 YEARS TO RELEASE PFIZER’S BLA DOCUMENTS
Plaintiff Public Health and Medical Professional s for Transparency submits this Appendix
in support of its Opposition to FDA’s Request for at Least 75 Years to Release Pfizer’s BLA
Documents.
EXHIBIT DESCRIPTION PAGE NO.
F D eclaration of Aaron Siri, Esq. App000632 –
App000 754
G U npublished Cases App000755 –
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Page 2 of 2
Dated: December 13, 2021
SIRI & GLIMSTAD LLP
_______________________ Aaron Siri, NY Bar No. 4321790 Elizabeth A. Brehm, NY Bar No. 4660353
Gabrielle G. Palmer, CO Bar No. 48948
200 Park Avenue
New York, New York 10166 Tel: (212) 532- 1091
Fax: (646) 417- 5967
[email protected]
[email protected]
[email protected]
HOWIE LAW, PC
John Howie
Texas Bar Number: 24027239 2608 Hibernia Street
Dallas, Texas 75204
Tel: (214) 622- 6340
[email protected]
Attorneys for Plaintiff
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Exhibit F
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1
UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF TEXAS
PUBLIC HEALTH AND MEDICAL
PROFESSIONALS FOR TRANSPARENCY, Plaintiff,
- against -
FOOD AND DRUG ADMINISTRATION,
Defendant.
Civil Action No. 4:21- cv-01058-P
DECLARATION OF AARON SIRI , ESQ.
I, Aaron Siri , declare as follows:
1. I am the Managing Partner of Siri & Glimstad LLP, counsel to Public Health and
Medical Professionals for Transparency ( “PHMPT ”). I am admitted to practice pro hac vice in
this action . I make this declaration in support of PHMPT ’s Opposition to FDA’s Request for at
Least 75 Years to Release Pfizer’s BLA Documents .
2. Exhibit 1, attached hereto, is a true and correct copy of an email exchange between
counsel for PHMPT and Courtney D. Enlow, counsel for the Food and Drug Administration
(“FDA ”). The most recent email in Exhibit 1 is dated November 5, 2021.
3. Exhibit 2, attached hereto, is a true and correct copy of an email exchange between
counsel for PHMPT and Courtney D. Enlow, counsel for the FDA. The most recent email in Exhibit 2 is dated December 10, 2021.
4. Exhibit 3, attached hereto, is a true and correct copy of an email exchange between
counsel for PHMPT and Antonia Konkoly, counsel for the FDA . The most recent email in Exhibit
3 is dated December 13, 2021.
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2
5. Exhibit 4, attached hereto, is a true and correct copy of an email from Michael
Kroeber of Business Intelligence Associates, Inc. to Nicky Tenney, a paralegal at my firm.
6. Exhibit 5, attached hereto, is a true and correct copy of a report by the National
Center for Health Statistics titled “Provisional Life Expectancy Estimates for January through
June, 2020” available at https://www.cdc.gov/nchs/data /vsrr/VSRR10 -508.pdf .
7. Exhibit 6, attached hereto, is a true and correct copy of a page on the FDA’s website
titled “Prescription Drug User Fee Amendments” available at https://www.fda.gov/industry/fda-
user-fee-programs/prescription-drug- user-fee-amendments .
8. Exhibit 7, attached hereto, is a true and correct copy of an ar ticle titled “Why is the
FDA Funded in Part by the Companies It Regulates?” available at https://today.uconn.edu/2021/05/why- is-the- fda-funded- in-part-by-the- companies -it-regulates -2/
.
9. Exhibit 8, attached hereto, is a true and correct copy of a press release titled “Pfizer
and BioNTech Initiate Rolling Submission of Biologics License Application For U.S. FDA Approval of Their COVID 19 Vaccine” avai lable at
https://www.pfizer.com/news/press -
release/press -release- detail/pfizer -and-biontech- initiate -rolling -submission-biologics .
10. Exhibit 9, attached hereto , is a true and correct copy of an article titled “Study
Shows ‘Traditional Linear Review’ Almost Accounts for 73% of e -Discovery Costs” available at
https://www.abajournal.com/advertising/article/reducing_costs_with_advance_review_strategies/
11. Exhibit 10, attached hereto, is a true and correct copy of an article titled “Advanced
Analytics Value for Small Docume nt Review Cases” available at
https://www.biaprotect.com/blog/advanced- analytics -value- for-small- document -review -cases/ .
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3
12. Exhibit 11, attached hereto, is a true and correct copy of an article titled “Answering
Your Questions about Legal Document Review” available at https://www.
biaprotect.com/blog/legal-document- review -q-a/.
13. Exhibit 12, attached hereto, is a true and correct copy of a webpage titled
“Docum ent Review Calculator” available at https://percipient.co/electronic -discovery- and-esi-
document- review -calculator/ .
14. Exhibit 13, attached hereto, is a true and correct copy of an article titled “Privilege
Analytics From H5: The Best Way To Handle Privilege Review” available at
https://abovethelaw.com/2021/12/privilege- analytics -from -h5-the- best-way-to-handle- privilege -
review/ .
15. Exhibit 14, attached hereto, is a true and correct copy of a Freedom of Information
Act (“FOIA ”) request submitted by my firm to the FDA on September 14, 2021.
16. Exhibit 15, attached hereto, is a true and correct cop y of the FDA’s response letter
and the production made in response to the FOIA request attached hereto as Exhibit 14.
17. Exhibit 16, attached hereto, is a true and correct copy of an article titled “Pfizer
raises Covid vaccine sales forecast to $36 billion for 2021” available at
https://www.cnbc.com/2021/11/02/pfizer- raises -covid- vaccine -sales -forecast -to-36-billion -.html .
Pursuant to 28 U.S.C. § 1746, I declare under penalty of perjury under the laws of the
United States of America that the foregoing is true and correct to the best of my knowledge.
Dated: December 13, 2021
Aaron Siri , Esq.
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Exhibit 1
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1Aaron Siri
From: Enlow, Courtney D. (CIV) <[email protected]>
Sent: Friday, November 5, 2021 8:39 AM
To: Aaron Siri
Cc: Elizabeth Brehm; Gabrielle Palmer
Subject: RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P
(N.D. Tex. 2021)
Aaron,
The FDA cannot agree to process and produce the non-exempt portions of more than 20,000 pages in less than a
month. Again, I’m not aware of any court ever ordering such a processing schedule. We also disagree with your
interpretation of the regulation and the other comments in your response, though I don’t think it would be productive
to continue a back-and-forth about those issues at this time.
Unfortunately, despite our best efforts to reach agreement on a schedule, I think we are too far apart and we should
propose our own schedules in paragraph 16 of the Joint Report. One you have entered your proposal into the draft,
please send it back to me so I can enter FDA’s proposal. In the meantime, please also let me know if you had edits to the
other sections, as I will need to run any language by folks on my end before we can file.
Thanks,
Courtney
From: Aaron Siri <[email protected]>
Sent: Friday, November 05, 2021 11:23 AM
To: Enlow, Courtney D. (CIV) <[email protected]>
Cc: Elizabeth Brehm <[email protected]>; Gabrielle Palmer <[email protected]>
Subject: [EXTERNAL] RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex.
2021)
Courtney,
I would submit that the review by the FDA to license this product required it to engage in extensive statistical analysis,
review, etc., that would have been more time consuming and involved than a review for exempt information. Also, with
a product that the federal government is mandating that millions of Americans receive under penalty of being fired from
their jobs while at the same time giving immunity to Pfizer for any injuries, this is a unique situation that demands the
FDA (as its own regulations reflect) immediately make the data underlying the licensure of this product public.
That said, if the FDA will agree to produce everything on the priority list below (which you state is 20,000+ pages) by
December 1, I will strongly recommend to my client accept that as an initial step.
I note that the product was licensed on November 23, 2021, and despite the passage of nearly two and a half months,
the FDA has not abided by even its own regulations to make a single page of the data it relied upon to license this
product available to the public. Not one page.
Thanks,
Aaron
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2From: Enlow, Courtney D. (CIV) < [email protected] >
Sent: Friday, November 5, 2021 8:13 AM
To: Aaron Siri < [email protected] >
Cc: Elizabeth Brehm < [email protected] >; Gabrielle Palmer < [email protected] >
Subject: RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex. 2021)
Hi Aaron,
Can you clarify what you mean by “produce this initial list by December 1”? Are you referring to a subset of the priority
list, or the entire 20,000+ pages?
Also, thanks for clarifying that PHMPT prioritized the CRFs. I had not understood that the top items were the items that
PHMPT wanted first; I assumed the list was not in any particular order.
Finally, I appreciate you letting me know why they think their timing is reasonable, though I would point out that FOIA
processing to ensure no exempt information is released is entirely different from the review cited by PHMPT.
Thanks,
Courtney
From: Aaron Siri < [email protected] > Sent: Friday, November 05, 2021 11:07 AM
To: Enlow, Courtney D. (CIV) < [email protected] >
Cc: Elizabeth Brehm < [email protected] >; Gabrielle Palmer < [email protected] >
Subject: [EXTERNAL] RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex.
2021)
Hi Courtney. I will need to confer with them but this proposal is not much different than what was originally proposed
by the FDA which was not taken well. I pushed hard to get them to come back with something more limited than the
entire file in 30 days which is reflected in the list below. Their repeated retort to me is that if the FDA can review the
entire submission by Pfizer in three months and license the product, the FDA should be able to release it in far less than
that amount of time. I also note that the list below was provided in the order of their priority but the FDA’s proposal
does not include the CRFs which are at the top of their list. Before I revert, can I tell them the FDA will produce this
initial list by December 1? If so, I can push hard for agreement to same. Thanks.
From: Enlow, Courtney D. (CIV) < [email protected] > Sent: Friday, November 5, 2021 7:57 AM
To: Aaron Siri < [email protected] >
Cc: Elizabeth Brehm < [email protected] >; Gabrielle Palmer < [email protected] >
Subject: RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex. 2021)
Hi Aaron,
Thanks for providing PHMPT’s desired priority list for processing responsive records. FDA has conducted an initial
assessment and has determined that PHMPT has requested that FDA process and produce the non-exempt portions of
over 20,000 pages by November 17. FDA cannot agree to such a schedule, nor am I aware of any court ever ordering the
production of that many pages in such a short timeframe.
That being said, FDA can agree to produce the non-exempt portions of some of PHMPT’s priority list by November
17. Specifically, FDA would agree to produce the non-exempt portions of the below records by November 17:
From Section 5.2 (as shown on PDF page 1):
o The Tabular Listing
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3o The Listing of Clinical Sites
From Section 5.3.6 (as shown on PDF page 2): the Reports of Postmarketing Experience
One SAS file (as shown on PDF page 10). As I’ve previously noted in my 11/3/21 3:08PM email, FDA is not used
to producing SAS files and is unsure of what, if any technical difficulties may arise in the processing of an SAS file,
so FDA would produce the non-exempt portions of one of the smaller SAS files.
FDA can also agree to produce the non-exempt portions of the remainder of Section 5.2 by December 1.
Because we received PHMPT’s priority list at 4:00 yesterday afternoon, we do not yet have proposed dates for the rest
of the items on the list. However, we are, of course, amenable to continuing our discussion on prioritizing and
processing dates for the other sections PHMPT identified on its priority list.
Please let me know if PHMPT will agree to these initial processing dates. If so, we can include this in our Joint Report
today and request to file a joint status report in 30 or 45 days to propose the next set of processing dates. If not, please
let me know as soon as possible if PHMPT has an alternate proposal.
Thanks,
Courtney
Courtney Enlow
Trial Attorney
U.S. Department of Justice
Civil Division, Federal Programs Branch
1100 L Street, N.W., Room 12102
Washington, D.C. 20005
(202) 616-8467
[email protected]
From: Aaron Siri < [email protected] >
Sent: Thursday, November 04, 2021 4:06 PM
To: Enlow, Courtney D. (CIV) < [email protected] >
Cc: Elizabeth Brehm < [email protected] >; Gabrielle Palmer < [email protected] >
Subject: [EXTERNAL] RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex.
2021)
Also, CFRs for site 1085 which is on page 33 of the PDF.
From: Aaron Siri
Sent: Thursday, November 4, 2021 12:58 PM
To: Enlow, Courtney D. (CIV) < [email protected] >
Cc: Elizabeth Brehm < [email protected] >; Gabrielle Palmer < [email protected] >
Subject: RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex. 2021)
Hi Courtney,
Nice meeting yesterday. Based on our follow-up preliminary discussion with our client earlier today, they would like to
know if the FDA will produce the following items by November 17:
1. Pdf page 27: CRFs for site 1055
2. Pdf page 31: CRFs for site 1081
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43. Pdf page 38: CRFs for site 1096
4. Pdf page 46: CRFs for site 1128
5. Pdf page 10: Program Files/SAS files. They want 3 to 4 SAS files as a sample, in the first instance, so that they
client can assess whether it would like to prioritize the complete universe of SAS files.
6. Pdf page 1: 5.2 - Tabular Listing of all Clinical Studies
7. Pdf page 1: 4 – Nonclinical Study Reports
8. Pdf page 2: 5.3.6 - Reports of Postmarketing Experience
9. Pdf page 3: 16.1.1 - Protocol and/or Amendment, and specifically, Final Analysis Interim Independent Oversight
Committees
10. Pdf page 6: Under the Analysis Datasets (ADaM), the Analysis Data Reviewers Guide, Analysis Dataset
Definition, and Analysis Dataset Definition Stylesheet
11. Pdf page 11: Tabulation Datasets
If we can get agreement on producing these limited items as noted, we can advise as much in our joint letter and that
we are continuing to discuss a production schedule for the remaining data and information.
Please let us know if the FDA will agree to their proposal.
Thanks,
Aaron
From: Enlow, Courtney D. (CIV) < [email protected] >
Sent: Thursday, November 4, 2021 11:07 AM
To: Gabrielle Palmer < [email protected] >
Cc: Aaron Siri < [email protected] >; Elizabeth Brehm < [email protected] >
Subject: RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex. 2021)
Hi Gabrielle and Aaron,
I’ve attached a draft joint report to address the court’s questions in the October 18 order. Please let me know if you
have a response to FDA’s proposals as outlined in my below emails. If the parties can reach agreement on any of these
proposals, we can include that agreement in the joint report. Otherwise, we can add our separate positions in
paragraph 16 and request a conference with the judge to set a processing schedule. If we have no agreement on any
issue, please let me know so I can draft FDA’s position for our joint report.
Thanks,
Courtney
From: Enlow, Courtney D. (CIV)
Sent: Wednesday, November 03, 2021 3:08 PM
To: Gabrielle Palmer < [email protected] >
Cc: Aaron Siri < [email protected] >; Elizabeth Brehm < [email protected] >
Subject: RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex. 2021)
Hi Aaron,
It was nice to meet you in person this morning. To follow up on our conversation this morning and my emails from
yesterday about SAS files, FDA has assessed as follows:
FDA is willing to produce SAS files to PHMPT with the caveats as outlined in this email.
FDA has not yet assessed whether it is feasible for FDA to redact or delete exempt information in SAS files. FDA
does not usually produce SAS files in response to FOIA requests, so FDA does not know if it may experience any
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5technical difficulties during processing of whether any type of conversion of files will be necessary to process
responsive records.
For any SAS files that do not contain exempt information (and thus do not require redaction/deletion), FDA is
willing to produce SAS files to PHMPT.
For any SAS files that do contain exempt information that would need to be redacted/deleted, FDA is willing to
produce SAS files if it is feasible for FDA to redact or delete in the SAS file. If it is not feasible to redact/delete in
SAS files, FDA would need to produce those files in either Excel or PDF. We can update you if such a conversion
is necessary.
Again, because FDA is not used to producing SAS files and does not know what technical difficulties may arise,
FDA proposes to produce the first SAS file to PHMPT on December 20. FDA has committed to producing that
data to PHMPT earlier than December 20 if FDA is able to process it before that time. Once FDA has produced
the first SAS file, we propose to confer about future processing dates for the remainder of the SAS files.
If PHMPT wants FDA to prioritize certain files from the PDF that I emailed yesterday, please let me know.
Finally, I hope to have the draft joint report to you today or tomorrow morning.
Best regards,
Courtney
From: Enlow, Courtney D. (CIV) Sent: Tuesday, November 02, 2021 6:37 PM
To: Gabrielle Palmer < [email protected] >
Cc: Aaron Siri < [email protected] >; Elizabeth Brehm < [email protected] >
Subject: RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex. 2021)
Hi Gabrielle,
As an update, FDA proposes a production date of December 1 for Section 5.2
FDA is amenable to producing documents in a format other than PDFs. However, the raw data files are in SAS format,
which is a spreadsheet-like file type that isn’t accessible to most people, and it appears difficult or perhaps even
impossible for FDA to redact exempt material from SAS files. FDA would be amenable to converting those SAS files to
Excel rather than PDF for FDA to review, delete the exempt information (as redacting is not possible in Excel), and
provide the non-exempt portions of those files to PHMPT. Therefore, while this wouldn’t be the “native” format that
PHMPT requested, it would allow PHMPT to use a non-PDF format to manipulate the file.
Because FDA does not yet have a sense of how long the conversion from SAS files to Excel files would take, FDA
proposes to produce the first raw data file to PHMPT by December 20 and then set a time to discuss future
productions. FDA anticipates that future productions would not take 45 days per file to process and produce, but it does
not have a good sense of how long it would take at this point because this is an atypical process for the agency.
Please let me know if this proposal is amenable to PHMPT. Also, please do let me know what time to meet Aaron in the
morning. Does 6:15 work?
Thanks,
Courtney
From: Enlow, Courtney D. (CIV)
Sent: Tuesday, November 02, 2021 6:02 PM
To: Gabrielle Palmer < [email protected] >
App000641Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 12 of 150 PageID 1464Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 12 of 150 PageID 1464
6Cc: Aaron Siri < [email protected] >; Elizabeth Brehm < [email protected] >
Subject: RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex. 2021)
Hi Gabrielle,
Yes, I can meet Aaron in the morning at the Starbucks near Terminal C at DCA. What time?
I’m still drafting a proposed joint report that I can send tomorrow. (Apologies for the delay, I’ve been tied up in
emergency briefing this week.)
Best regards,
Courtney
From: Gabrielle Palmer < [email protected] > Sent: Tuesday, November 02, 2021 5:28 PM
To: Enlow, Courtney D. (CIV) < [email protected] >
Cc: Aaron Siri < [email protected] >; Elizabeth Brehm < [email protected] >
Subject: [EXTERNAL] RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex.
2021)
Courtney,
Will you please send us your proposed motion? Also, Aaron’s plan is to take a 7am flight on American Airlines tomorrow
morning. Are you able to meet him at DCA before his flight? There is a pre-security Starbucks near Terminal C, so if
you’re available, that could be a good meeting location.
Gabrielle G. Palmer, Attorney
Siri | Glimstad
200 Park Avenue
Seventeenth Floor
New York, NY 10166
Main: 212-532-1091
Facsimile: 646-417-5967
www.sirillp.com
This email may contain material that is confidential, privileged and/or attorney work product for the sole use of the intended recipient. Any
review, reliance or distribution by others or forwarding without express permission is strictly prohibited. If you are not the intended recipient,
please contact the sender and delete all copies.
From: Enlow, Courtney D. (CIV) < [email protected] >
Sent: Tuesday, November 2, 2021 10:54 AM
To: Gabrielle Palmer < [email protected] >
Cc: Aaron Siri < [email protected] >; Elizabeth Brehm < [email protected] >
Subject: RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex. 2021)
Good afternoon Aaron and Gabrielle,
I’m writing to provide you an update on FDA’s initial assessment of records responsive to PHMPT’s FOIA request.
In terms of volume, FDA has determined that the original Cominarty BLA submission contains at least 329,000 pages. Of
those pages, approximately 322,000 pages are contained in section 5 of the application.
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7FDA is still working on providing a proposed date for processing and production of the non-exempt portions of Section
5.2. I hope to have that proposed date to you today or tomorrow.
To help prioritize processing and production, FDA provides the attached “index” of several subsections of Section 5.3. As
you will see, the FDA has provided estimates of the number of pages in various subsections. We would ask PHMPT to
review that index and select the sections that they would like to prioritize. Once we understand their prioritization, we
can offer production estimates for the subsections they prioritize.
Also, you had mentioned that PHMPT does not want anything that has been publicly released on any website. We are,
of course, happy to narrow PHMPT’s FOIA request, but we want to ensure that the parties are in agreement on which
records do not need to be processed and produced. Accordingly, FDA requests that PHMPT provide a list of BLA sections
that they wish to exclude from their FOIA request because they have obtained those sections from other sources.
With regard to the parties’ joint motion for relief from the scheduling order, I’m concerned that since the parties’ joint
report is due Friday, we don’t have sufficient time to seek relief from the order. Therefore, I propose that we file the
joint report contemplated by the order and state that we don’t believe certain sections are applicable to a FOIA
case. This will also allow us to set forth different views on different issues if need be. I can take the lead on drafting.
Finally, Aaron, do you have any update on your availability to meet before you head back to New York? I have several
meetings and a hearing tomorrow morning that I will need to work around.
Thanks,
Courtney
From: Gabrielle Palmer < [email protected] >
Sent: Friday, October 29, 2021 5:31 PM
To: Enlow, Courtney D. (CIV) < [email protected] >
Cc: Aaron Siri < [email protected] >; Elizabeth Brehm < [email protected] >
Subject: [EXTERNAL] RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex.
2021)
Hi Courtney,
Our proposed revisions are attached. Aaron will respond to you separately about his trip to DC.
Gabrielle G. Palmer, Attorney
Siri | Glimstad
200 Park Avenue
Seventeenth Floor
New York, NY 10166
Main: 212-532-1091
Facsimile: 646-417-5967
www.sirillp.com
This email may contain material that is confidential, privileged and/or attorney work product for the sole use of the intended recipient. Any
review, reliance or distribution by others or forwarding without express permission is strictly prohibited. If you are not the intended recipient,
please contact the sender and delete all copies.
From: Enlow, Courtney D. (CIV) < [email protected] >
Sent: Friday, October 29, 2021 1:55 PM
To: Gabrielle Palmer < [email protected] >
App000643Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 14 of 150 PageID 1466Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 14 of 150 PageID 1466
8Cc: Aaron Siri < [email protected] >; Elizabeth Brehm < [email protected] >
Subject: RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex. 2021)
Hi Gabrielle,
Following up on my email below. Do you have any additional edits to the motion? Also, since it looks like we likely
won’t get this on file in time for it to be granted, can you please let me know if Aaron will be traveling to DC via Reagan
National Airport (DCA)? It would be much more convenient to meet somewhere near there as opposed to anywhere
near the Capitol.
Thank you,
Courtney
Courtney Enlow
Trial Attorney
U.S. Department of Justice
Civil Division, Federal Programs Branch
1100 L Street, N.W., Room 12102
Washington, D.C. 20005
(202) 616-8467
[email protected]
From: Enlow, Courtney D. (CIV)
Sent: Thursday, October 28, 2021 3:47 PM
To: Gabrielle Palmer < [email protected] >
Cc: Aaron Siri < [email protected] >; Elizabeth Brehm < [email protected] >
Subject: RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex. 2021)
Hi Gabrielle,
I’ve attached some proposed edits to the joint motion. I thought it was necessary to provide a bit more explanation in
the first paragraph. Please let me know if you have any additional edits.
Thank you,
Courtney
Courtney Enlow
Trial Attorney
U.S. Department of Justice
Civil Division, Federal Programs Branch
1100 L Street, N.W., Room 12102
Washington, D.C. 20005
(202) 616-8467
[email protected]
From: Gabrielle Palmer < [email protected] >
Sent: Wednesday, October 27, 2021 2:13 PM
App000644Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 15 of 150 PageID 1467Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 15 of 150 PageID 1467
9To: Enlow, Courtney D. (CIV) < [email protected] >
Cc: Aaron Siri < [email protected] >; Elizabeth Brehm < [email protected] >
Subject: [EXTERNAL] RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex.
2021)
Hi Courtney,
Please see the attached letter and draft motion to excuse compliance with Rules 26 and 16.
Thanks,
Gabrielle G. Palmer, Attorney
Siri | Glimstad
200 Park Avenue
Seventeenth Floor
New York, NY 10166
Main: 212-532-1091
Facsimile: 646-417-5967
www.sirillp.com
This email may contain material that is confidential, privileged and/or attorney work product for the sole use of the intended recipient. Any
review, reliance or distribution by others or forwarding without express permission is strictly prohibited. If you are not the intended recipient,
please contact the sender and delete all copies.
From: Enlow, Courtney D. (CIV) < [email protected] >
Sent: Monday, October 25, 2021 5:37 PM
To: Gabrielle Palmer < [email protected] >
Cc: Aaron Siri < [email protected] >; Elizabeth Brehm < [email protected] >
Subject: RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex. 2021)
Hi Gabrielle,
Thanks for your flexibility and for taking the lead on the motion. For Wednesday’s 2:30 call, please use the below dial-in:
1-877-465-7975
15519379#
Thanks,
Courtney
Courtney Enlow
Trial Attorney
U.S. Department of Justice
Civil Division, Federal Programs Branch
1100 L Street, N.W., Room 12102
Washington, D.C. 20005
(202) 616-8467
[email protected]
App000645Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 16 of 150 PageID 1468Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 16 of 150 PageID 1468
10From: Gabrielle Palmer < [email protected] >
Sent: Monday, October 25, 2021 7:34 PM
To: Enlow, Courtney D. (CIV) < [email protected] >
Cc: Aaron Siri < [email protected] >; Elizabeth Brehm < [email protected] >
Subject: [EXTERNAL] RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex.
2021)
Hi Courtney,
Sorry for the delay. We are available at 2:30pm EST on Wednesday. If that works for you, please let us know as soon as
possible. Yes, we will take the lead on the motion.
Gabrielle G. Palmer, Attorney
Siri | Glimstad
200 Park Avenue
Seventeenth Floor
New York, NY 10166
Main: 212-532-1091
Facsimile: 646-417-5967
www.sirillp.com
This email may contain material that is confidential, privileged and/or attorney work product for the sole use of the intended recipient. Any
review, reliance or distribution by others or forwarding without express permission is strictly prohibited. If you are not the intended recipient,
please contact the sender and delete all copies.
From: Enlow, Courtney D. (CIV) < [email protected] >
Sent: Monday, October 25, 2021 2:46 PM
To: Gabrielle Palmer < [email protected] >
Cc: Aaron Siri < [email protected] >; Elizabeth Brehm < [email protected] >
Subject: RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex. 2021)
Hi Gabrielle and Aaron,
I write to follow up on our call from Friday afternoon and on my email below.
During Friday’s call, you requested the “table of contents” from the BLA. Although BLA files generally may contain tables
of contents, FDA’s preliminary review has not identified a table of contents as part of the electronically filed Cominarty
BLA. Although not obligated to do so, FDA provides below some non-privileged information from screenshots of FDA’s
internal filing system that show titles of different sections of the BLA. These screenshots have similar information as a
table of contents and may help to inform the parties’ discussions about reasonable prioritization and production
schedule.
There are 4 Sections in the Original BLA submission (STN 125742/0/0) for Comirnaty (as shown below). When in the
database, the arrows at the far left of the text can be clicked to expand the sections.
App000646Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 17 of 150 PageID 1469Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 17 of 150 PageID 1469
11
The following screenshots come from the same database showing partial expansion of sections 2 and 5. (Please note
that the “sheet of paper” icon designates an individual record.)
:: • BlA • 125742 (0001 -> 12574210 .0 (OriglNI Appllc:•tion ) • Recd 2021-0>06 • OATS# 1067058) • docu&ldge [CBER0P>odu.:1JOn]
,lf.M <nOf'IP V
1 ( (
" -,0001->1::'1.t!-O0(()rag,,,r,tiAppl(.IOOl'IJ•ltetd:O:l..os,.(16 _._0.T_S0_106_IOSO _____ -----< . a , ,..,....-:n. ~ atlO PtMC~ ~
• /j2COftWl'JOftT~Ooc\,IIWII~
• • 'Honclrlltel Stl.ldy lttCIOIU • ., ,can. .. _ -
ams !l.; -------< .
_.. ~ 0001 --> 125742/0.0 (Original Application )-Recd 2021-05-06-
► 1 Administrative Information and Prescribing Information
_.. 2 Common Technical Document Summaries
_.. D] 2.2 Introduction
D (0001] Introduction
_.. 2.4 Nonclinical Overview n (0001] Nonclinical Overview
_.. D] 2.5 Clinical Overview
0 (0001] Clinical Overview
... 2.6 Nonclin ical Written and Tabulated Summaries
~ -DJ 2.6.1 Introduction
[] (0001] Introduction
_.. DJ 2.6.2 Pharmaco logy Written Summary
lJ (0001] Pharmacology Written Summary
~ .[Jl 2.6.3 Pharmaco logy Tabulated Summary
[J (0001] Pharmacology Tabulated Summary
_.. l}] 2.6.4 Pharmacok inetics Written Summary
[ J [0001] Pharmacokinetics Written Summary
App000647Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 18 of 150 PageID 1470Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 18 of 150 PageID 1470
12
You requested prioritization of raw data from the BLA and Pfizer’s own analysis of its data. We think it would be more
productive to discuss this request further with you once you have reviewed the Clinical Overview and the summaries of 2.6.5 Phannacoklnetlcs Tabulated Summary
(0001) Phannacoklnetlcs Tabulated Summary
2.6.6 Toxicology Written Summary
(0001) Toxicology Written Summary
2.6.7 Toxicology Tabulated Summary
(0001) Toxicology Tabulated Summary
" 2.7 Clinical Summary
" 2.7.1 Summary of Blophannaceutlc Studies and Associated Analytical Methods
(0001) Summary of Blophannaceutlc Studies and Associated Analytical Methods
2.7.3 Summary of Clinical Efficacy
(0001) Summary of Clinical Efficacy
2.7.4 Summary of Clinical Safety
(0001) Summary of Clinical Safety
2. 7 .5 Literature-References
(0001) Literature References
2.7.6 Synopses of Individual Studies
(0001) Synopses of Individual Studies
► 4 Nonclinical Study Reports
► 4 Nonclinical Study Reports
... 5 Clinical Study Reports
... 5.2 Tabular Listing of all Clinical Studies
l ] [0001] Tabular Listing
I I [0001] Listing of Clinical Sites and CVs
... DJ 5.3 Clinical Study Reports
► 5.3.1 Reports of Biopharmaceutic Studies
..1111 5.3.5 Reports of Efficacy and Safety Studies
-" JJ] 5.3.5.1 Study Reports of Controlled Clinical StL
► [0001] C4591001 -A Phase 1/2/3, Placebo-
► [0001] BNT162-01 -A Multi-Site, Phase 1/11,
..1111 J,Jl 5.3.6 Reports of Postmarketing Experience
-" [0001] Postmarketing Experience
... Study Report Body Chapter
11.,_ [0001] Cumulative Analysis of Post-Autt
► DJ 5.4 Literature References
App000648Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 19 of 150 PageID 1471Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 19 of 150 PageID 1471
13clinical safety and efficacy section, which FDA plans to produce in the near future. But based on your request, we
believe that the best prioritization may be as follows:
Initially (to provide you better insight into what is contained in the BLA to help inform discussions of
prioritization):
Section 2.5 Clinical Overview 334 pages – by approx. Nov. 5th
Section 2.7.4 Summary of Clinical Safety 344 pages – by approx. Nov. 22nd
Section 2.7.3 Summary of Clinical Efficacy 182 pages – by approx. Nov. 22nd
Based on your most recent requests, we think it would make sense to prioritize the following reports from the
BLA, which contain Pfizer’s analysis and summaries of the data:
Section 5.3.6 Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162B2) Received
Through 28-Feb-2021 38 pages
From Section 5.3.5.1 C4591001- Phase 1/2/3…; Study Report Body Chapter:
Final Analysis Interim Synopsis 31 pages
Final Analysis Interim Report Body 2033 pages
Final Analysis Interim Errata 1 page
If you agree that this is an appropriate prioritization, we can estimate production dates for these sections.
Lastly, as it pertains to my below email, I am not able to have a call tomorrow, but I could discuss further on
Wednesday. Also, please confirm that you are planning on taking the lead on drafting a motion for relief from the
Court’s Order.
Best regards,
Courtney
Courtney Enlow
Trial Attorney
U.S. Department of Justice
Civil Division, Federal Programs Branch
1100 L Street, N.W., Room 12102
Washington, D.C. 20005
(202) 616-8467
[email protected]
From: Enlow, Courtney D. (CIV)
Sent: Friday, October 22, 2021 5:52 PM
To: Gabrielle Palmer < [email protected] >
Cc: Aaron Siri < [email protected] >; Elizabeth Brehm < [email protected] >
Subject: RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex. 2021)
Hi Gabrielle and Aaron,
I apologize, but something has come up on Tuesday. Are you available on Wednesday afternoon instead?
Also, were you planning on taking the lead on drafting a motion for relief from the Court’s Order?
Thanks,
Courtney
App000649Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 20 of 150 PageID 1472Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 20 of 150 PageID 1472
14
Courtney Enlow
Trial Attorney
U.S. Department of Justice
Civil Division, Federal Programs Branch
1100 L Street, N.W., Room 12102
Washington, D.C. 20005
(202) 616-8467
[email protected]
From: Enlow, Courtney D. (CIV)
Sent: Friday, October 22, 2021 3:15 PM
To: Gabrielle Palmer < [email protected] >
Cc: Aaron Siri < [email protected] >; Elizabeth Brehm < [email protected] >
Subject: RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex. 2021)
Hi Gabrielle and Aaron,
It was nice to speak to you today. For our call at 2:00 on Tuesday, please use the below dial-in:
1-877-465-7975
15519379#
I hope you both have a relaxing weekend.
Best regards,
Courtney
Courtney Enlow
Trial Attorney
U.S. Department of Justice
Civil Division, Federal Programs Branch
1100 L Street, N.W., Room 12102
Washington, D.C. 20005
(202) 616-8467
[email protected]
From: Gabrielle Palmer < [email protected] >
Sent: Wednesday, October 20, 2021 4:56 PM
To: Enlow, Courtney D. (CIV) < [email protected] >
Cc: Aaron Siri < [email protected] >; Elizabeth Brehm < [email protected] >
Subject: [EXTERNAL] RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex.
2021)
Hi Courtney,
We are available at 2pm EST on Friday. Will you kindly circulate dial-in information?
App000650Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 21 of 150 PageID 1473Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 21 of 150 PageID 1473
15
Gabrielle G. Palmer, Attorney
Siri | Glimstad
200 Park Avenue
Seventeenth Floor
New York, NY 10166
Main: 212-532-1091
Facsimile: 646-417-5967
www.sirillp.com
This email may contain material that is confidential, privileged and/or attorney work product for the sole use of the intended recipient. Any
review, reliance or distribution by others or forwarding without express permission is strictly prohibited. If you are not the intended recipient,
please contact the sender and delete all copies.
From: Enlow, Courtney D. (CIV) < [email protected] >
Sent: Wednesday, October 20, 2021 2:49 PM
To: Gabrielle Palmer < [email protected] >
Cc: Aaron Siri < [email protected] >; Elizabeth Brehm < [email protected] >
Subject: RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex. 2021)
Hi Gabrielle,
Thanks for reaching out. I’m available between 1 and 3 on Friday afternoon. If that doesn’t work for you, I can propose
some times early next week.
I look forward to working with you all as well.
Best regards,
Courtney
Courtney Enlow
Trial Attorney
U.S. Department of Justice
Civil Division, Federal Programs Branch
1100 L Street, N.W., Room 12102
Washington, D.C. 20005
(202) 616-8467
[email protected]
From: Gabrielle Palmer < [email protected] >
Sent: Wednesday, October 20, 2021 4:43 PM
To: Enlow, Courtney D. (CIV) < [email protected] >
Cc: Aaron Siri < [email protected] >; Elizabeth Brehm < [email protected] >
Subject: [EXTERNAL] Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex. 2021)
Hi Courtney,
App000651Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 22 of 150 PageID 1474Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 22 of 150 PageID 1474
16We are counsel for Public Health and Medical Professionals for Transparency in the above referenced action. Are you
available to discuss this case at any time over the next few working days? If so, please propose some times that you are
available.
We look forward to working with you.
Thanks,
Gabrielle G. Palmer, Attorney
Siri | Glimstad
200 Park Avenue
Seventeenth Floor
New York, NY 10166
Main: 212-532-1091
Facsimile: 646-417-5967
www.sirillp.com
This email may contain material that is confidential, privileged and/or attorney work product for the sole use of the intended recipient. Any
review, reliance or distribution by others or forwarding without express permission is strictly prohibited. If you are not the intended recipient,
please contact the sender and delete all copies.
App000652Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 23 of 150 PageID 1475Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 23 of 150 PageID 1475
Exhibit 2
App000653Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 24 of 150 PageID 1476Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 24 of 150 PageID 1476
From: Aaron Siri
To: Enlow, Courtney D. (CIV)
Cc: Elizabeth Brehm ; Gabrielle Palmer
Subject: RE: PHMPT v. FDA, No. 21-cv-1058 (N.D. Tex.)
Date: Friday, December 10, 2021 11:23:12 AM
Good afternoon Courtney,
One additional question:
7. Will the FDA accept funds from the Plaintiff to hire sufficient reviewers to review the
needed documents within the time requested by Plaintiff?
If you could kindly let me know the answers to these questions asap, it would be appreciated.
Best regards,Aaron
From:
Aaron Siri
Sent: Thursday, December 9, 2021 12:05 PM
To: 'Enlow, Courtney D. (CIV)' <[email protected]>Cc: Elizabeth Brehm <[email protected]>; Gabrielle Palmer <[email protected]>
Subject: RE: PHMPT v. FDA, No. 21-cv-1058 (N.D. Tex.)
Good afternoon, Courtney,
Further to my emails below, please also:
5. Provide a list of the sections of the index that were not disclosed in the PDF index you
provided.
6. An index for the documents in the BLA file that were not included in the index already
provided (meaning, an index of the material that was not submitted as part of Comirnaty BLAapplication).
The FOIA request, on its face, was for more than just the Comirnaty BLA submitted by
Pfizer.
Once I have answers to these six questions, my client will be in a position to revert to the proposalmade by the FDA.
Thanks,Aaron
From:
Aaron Siri
Sent: Wednesday, December 8, 2021 2:23 PM
To: Enlow, Courtney D. (CIV) < [email protected] >
Cc: Elizabeth Brehm < [email protected] >; Gabrielle Palmer < [email protected] >
App000654Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 25 of 150 PageID 1477Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 25 of 150 PageID 1477
Subject: RE: PHMPT v. FDA, No. 21-cv-1058 (N.D. Tex.)
Good afternoon, Courtney,
Thank you for the response.
Four hopefully simple questions/requests:
1. You claim it would take 1.5 days to determine the number of lines in the 126 data files, each
similar to a spreadsheet.
That estimate is difficult to understand since I would imagine it would
require no more than someone opening each file, recording the total number of lines for each one,and then adding up the total number of lines.
A paralegal at our firm could accomplish that task in
less than an hour.
Please explain why it would take 1.5 days to open each file and record the total
number of lines in each file?
2. For the data files, please provide the column headers.
My client would like to see these to
determine if there is anything that can be streamlined.
3. Please provide a more precise number for the category you indicated has “tens of thousands ofadditional pages.”
4.
Would the FDA be interested in hiring qualified unpaid volunteers to assist with reviewing the
documents requested by PHMPT?
Best regards,Aaron
From:
Enlow, Courtney D. (CIV) < [email protected] >
Sent: Thursday, December 2, 2021 2:25 PM
To: Aaron Siri < [email protected] >
Cc: Elizabeth Brehm < [email protected] >; Gabrielle Palmer < [email protected] >
Subject: RE: PHMPT v. FDA, No. 21-cv-1058 (N.D. Tex.)
Good afternoon Aaron,
With regard to your first two questions, FDA will not be able to make those assessments at this time.
In order for FDA to determine (1) the number of lines of spreadsheet data or (2) the total number of
pages for each line of the 87-page Index, FDA would need to perform a search by hand.
In other
words, an individual would have to click open each file listed on the 87-page Index to determine thesize of the file, and then manually record the file’s size.
To perform that search for the number of
lines of spreadsheet data, FDA estimates that it would take 1.5 days of a staff member’s time; toprovide the page counts for each entry in the Index, FDA estimates that it would take several days ofa staff member’s time.
Due to the heavy burden such an effort would place on FDA’s limited
resources, it is not feasible for FDA to provide those estimates.
With regard to your third question, are you asking whether there is any data in the Comirnaty
App000655Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 26 of 150 PageID 1478Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 26 of 150 PageID 1478
biological product file that are not accounted for in the Index or the estimated 329,000+ page
count? If so, the Cominarty biological product file also contains supplements, amendments, and
product correspondence.
FDA estimates that there are approximately 39,000 pages of records in
that category.
In addition, there may be investigational new drug records that may be supportive of
the BLA.
Although FDA cannot provide a precise count at this time, FDA estimates that there would
be tens of thousands of additional pages in this category.
These page counts are in addition to FDA’s
estimate of 329,000+ pages (plus data files) in the original Cominarty BLA.
If Plaintiff is amenable to the schedule I proposed yesterday, please let me know this week so that
we can inform the Court.
Thanks,Courtney
Courtney EnlowTrial AttorneyU.S. Department of JusticeCivil Division, Federal Programs Branch1100 L Street, N.W., Room 12102Washington, D.C. 20005(202) [email protected]
From:
Aaron Siri < [email protected] >
Sent: Wednesday, December 01, 2021 5:56 PM
To: Enlow, Courtney D. (CIV) < [email protected] >
Cc: Elizabeth Brehm < [email protected] >; Gabrielle Palmer < [email protected] >
Subject: [EXTERNAL] RE: PHMPT v. FDA, No. 21-cv-1058 (N.D. Tex.)
Good afternoon Courtney,
Thank you for the note.
In order for me to have a meaningful conversation with my client, can you
please let me know (1) approximately how many lines of spreadsheet data would need to beprocessed, (2) the approximate total number of pages for each line item in the Index of ComirnatyBLA you previously provided (copy attached) and (3) what else is in the biological product file forComirnaty that is not reflected in the attached and is that included in the estimated 329,000 pagecount (and if not, how many pages does that consist of).
Thank you,Aaron
App000656Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 27 of 150 PageID 1479Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 27 of 150 PageID 1479
From: Enlow, Courtney D. (CIV) < [email protected] >
Sent: Wednesday, December 1, 2021 8:35 AM
To: Aaron Siri < [email protected] >; Gabrielle Palmer < [email protected] >
Cc: Elizabeth Brehm < [email protected] >
Subject: RE: PHMPT v. FDA, No. 21-cv-1058 (N.D. Tex.)
Good morning Aaron,
With regard to PHMPT v. FDA
, No. 21-cv-1058 (N.D. Tex.), FDA has now had the opportunity to
assess the number of responsive pages and to estimate processing times for additional portions of
Plaintiff’s priority list.
In light of that assessment, FDA proposes that it produce the non-exempt
portions of the following records by the below dates:
· By December 13, 2021, FDA plans to produce publicly releasable information from:
o Plaintiff’s priority item #1 - CRF files for site 1055 (~2,030 pages);
o Completion of Plaintiff’s priority item #5 -
§ Four additional .txt files that were listed on p. 10 of the index;
§ Four additional SAS files (not specifically listed on Plaintiff’s priority list, but
mentioned as something Plaintiff was interested in).
o Publicly releasable information from the following additional sections of the original
Comirnaty BLA:
§ Section 2.5 – Clinical Overview (~333 pages)
§ Section 2.7.3 – Summary of Clinical Efficacy (~182 pages)
§ Section 2.7.4 – Summary of Clinical Safety (~344 pages)
· By December 30, 2021, FDA plans to produce publicly releasable information from
Plaintiff’s priority item #2 – CRF files for site 1081 (~3,380 pages);
· By January 18, 2022, FDA plans to produce publicly releasable information from Plaintiff’s
priority item #3 – CRF files for site 1096 (~2,937 pages); and
· By January 31, 2022, FDA plans to produce publicly releasable information from Plaintiff’s
priority item #4 – CRF files for site 1128 (~3,452 pages).
Under this schedule, by the end of January 2022, FDA expects to have produced publicly releasableinformation from more than 12,000 pages of records and 10 unpaginated .txt or SAS data files.
(This
page and file count includes records produced to Plaintiff on November 17, 2021, and records thatwill be produced to Plaintiff later today.)
FDA will also have completed production of seven of the
first eight items on the priority list Plaintiff provided to FDA on November 4, 2021.
App000657Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 28 of 150 PageID 1480Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 28 of 150 PageID 1480
After the January 31, 2022 production, FDA proposes to make one production at the end of each
subsequent month totaling a minimum the non-exempt portions of 500 pages. (For purposes of
calculating a “page count” of data records that are not paginated, FDA proposes considering twenty
lines of spreadsheet data the equivalent of one page.
For example, production of a spreadsheet
containing 2,000 lines of data would be counted the equivalent of a 100-page PDF record.)
To the
extent feasible, FDA plans to continue to prioritize records from Plaintiff’s priority list.
Although FDA
proposes a minimum rate of 500 pages a month, FDA will continue to produce records at a fasterrate where feasible.
Please let me know if Plaintiff is amenable to this proposed schedule.
If so, I propose that the parties
file a joint status report setting out the agreed-upon schedule and requesting that the Court cancelthe hearing set for December 14 and the briefing deadlines.
Thanks,Courtney
Courtney EnlowTrial AttorneyU.S. Department of JusticeCivil Division, Federal Programs Branch1100 L Street, N.W., Room 12102Washington, D.C. 20005(202) [email protected]
From:
Enlow, Courtney D. (CIV)
Sent: Wednesday, November 17, 2021 1:40 PM
To: Aaron Siri < [email protected] >; Gabrielle Palmer < [email protected] >
Cc: Elizabeth Brehm < [email protected] >
Subject: PHMPT v. FDA, No. 21-cv-1058 (N.D. Tex.)
Good afternoon Aaron and Gabrielle,
I’ve attached correspondence from FDA and a release of records in PHMPT v. FDA
, No. 21-cv-1058
(N.D. Tex.).
Kindly confirm receipt.
Thanks,Courtney
Courtney EnlowTrial AttorneyU.S. Department of Justice
App000658Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 29 of 150 PageID 1481Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 29 of 150 PageID 1481
Civil Division, Federal Programs Branch
1100 L Street, N.W., Room 12102
Washington, D.C. 20005(202) [email protected]
App000659Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 30 of 150 PageID 1482Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 30 of 150 PageID 1482
Exhibit 3
App000660Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 31 of 150 PageID 1483Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 31 of 150 PageID 1483
1Aaron Siri
From: Aaron Siri
Sent: Monday, December 13, 2021 2:39 PM
To: 'Konkoly, Antonia (CIV)'
Cc: Enlow, Courtney D. (CIV); Elizabeth Brehm; Gabrielle Palmer
Subject: RE: PHMPT -- conferral questions
Good afternoon, Antonia,
Thanks, and let me reiterate that the list previously provided by Plaintiff was for initial documents to be produced by
November 17 so that it could get a general sense of the overall biologic product file documents. The list was not a
priority list of what was more, or less, relevant or useful. As Plaintiff has made clear numerous times – until everything
is produced, it cannot conduct a meaningful review.
As for your responses below, it is unfortunate the FDA will not provide even the basic information regarding the file at
issue, even withholding the index of its content. If the FDA will change its position on same, let me know, otherwise this
will be a separate issue we will need to take up with the Court.
Thanks,
Aaron
From: Konkoly, Antonia (CIV) <[email protected]>
Sent: Saturday, December 11, 2021 6:21 PM
To: Aaron Siri <[email protected]>
Cc: Enlow, Courtney D. (CIV) <[email protected]>; Elizabeth Brehm <[email protected]>; Gabrielle Palmer
<[email protected]>
Subject: RE: PHMPT -- conferral questions
Hi Aaron –
I believe I did answer that question; see highlighted below. To the extent that the premise of your follow up is that there
is a distinction between the Plaintiff paying a set of people directly, and Plaintiff giving money to the FDA to hire new
employees to do this work, there is no such distinction. Plaintiff may not privately fund the hiring of additional FDA
employees to do the processing work required by Plaintiff’s request. That is simply not how the federal government
works.
Thank you,
Toni
From: Aaron Siri < [email protected] >
Sent: Saturday, December 11, 2021 8:13 PM
To: Konkoly, Antonia (CIV) < [email protected]>
Cc: Enlow, Courtney D. (CIV) < [email protected] >; Elizabeth Brehm < [email protected] >; Gabrielle Palmer
<[email protected] >
Subject: [EXTERNAL] RE: PHMPT -- conferral questions
Good evening, Toni,
Thanks, welcome, and look forward to working with you on this matter as well.
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2I quickly glanced at your email below and noticed that there was one more question that was not answered:
7. Will the FDA accept funds from the Plaintiff to hire sufficient reviewers to review the needed documents
within the time requested by Plaintiff?
As for the responses you sent below, I will review and revert. In the meantime, kindly let me know the answer to the
above question.
Thank you,
Aaron
From: Konkoly, Antonia (CIV) < [email protected] > Sent: Friday, December 10, 2021 6:57 PM
To: Aaron Siri < [email protected] >; Elizabeth Brehm < [email protected] >; Gabrielle Palmer < [email protected] >
Cc: Enlow, Courtney D. (CIV) < [email protected] >
Subject: PHMPT -- conferral questions
Hi Aaron et al –
I assume you saw the NOA that I entered earlier this week; I’m a colleague of Courtney’s and will be handling the
hearing on Tuesday. I look forward to working with you. We’ve conferred with FDA regarding the various questions
you’ve posed; please see below the agency’s responses, in red.
1.) You claim it would take 1.5 days to determine the number of lines in the 126 data files, each similar to a
spreadsheet. That estimate is difficult to understand since I would imagine it would require no more than
someone opening each file, recording the total number of lines for each one, and then adding up the total
number of lines. A paralegal at our firm could accomplish that task in less than an hour. Please explain
why it would take 1.5 days to open each file and record the total number of lines in each file?
o First, FDA derived the number 126 came from its search of a specific portion of the BLA file (within
Section 5). However, FDA expects that there are data files in other sections of the application, so 126 is
likely not the full number of SAS files for the entire BLA. Accordingly, some the time estimate accounts
for the time that would be needed to search for and locate other files. Additionally, SAS files are large
and can present technical difficulties for FDA staff to open and navigate. Both search time and expected
technical difficulties are thus accounted for in the 1.5 day estimate.
2.) For the data files, please provide the column headers. My client would like to see these to determine if
there is anything that can be streamlined.
o Due to the same technical difficulties noted above – which, on the ground, would make this task quite
time-consuming – FDA is not able to accommodate this request at this time. In short, the diversion of
time this would involve would meaningfully undermine the agency’s ability to focus on its processing
work.
3.) Please provide a more precise number for the category you indicated has “tens of thousands of additional
pages.”
o FDA knows that there are a number of records in the IND section of the biological product file; however,
it would take a closer review of those pages to determine which information would be considered
supportive of the BLA/licensure and, thus, publicly available (subject to disclosure review) under 21
C.F.R. 601.51(e).
You may already be aware of this, but to make sure we’re on the same page – IND files may include
studies for several forms (different dose strengths, formulations, etc.) and/or indications (different
disease conditions, age groups, etc.). It’s possible for a biological product to be approved for only a
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3subset of the variations/indications for which it was originally studied. The portions of the IND file
related to the approved conditions would become part of the biological product file that would be
available for disclosure (subject to confidentiality review) once the product is approved; portions of the
IND related to unapproved forms/indications would remain confidential (as would the existence of these
portions).
To be clear, FDA disclosure staff have not yet determined whether portions of the IND section of the
Comirnaty file refer to forms or conditions that are have not been approved under a BLA. Thus, this
response should not be understood as an indication that any parts of the biological product file relate to
INDs associated with a product that has not been approved. But, before performing that review (which
would require a substantial investment of time from FDA), we cannot provide a precise page estimate.
Because, again, the FDA assesses that that this effort does not justify the diversion of resources away
from its processing work, it also cannot accommodate this request at this time.
4.) Would the FDA be interested in hiring qualified unpaid volunteers to assist with reviewing the documents requested by PHMPT?
o This is not an option. Non-federal personnel – whether they be unpaid volunteers, or per your later
question, persons paid by the Plaintiff – cannot perform federal work.
5.) Provide a list of the sections of the index that were not disclosed in the PDF index you provided.
o FDA provided the high-level breakout of the entire original Comirnaty BLA. (See p. 1 of the Index
provided on 11-4-21.) However, in accordance with the purpose of the index—ie, to assist PHMPT in
honing in on the portions of the BLA that it is most interested in—FDA did not expand the index as to
Sections that were not identified by PHMPT’s Priority List. Additionally, other sections could not be
expanded because to do so could have revealed confidential information.
6.) An index for the documents in the BLA file that were not included in the index already provided (meaning,
an index of the material that was not submitted as part of Comirnaty BLA application). The FOIA request,
on its face, was for more than just the Comirnaty BLA submitted by Pfizer.
o Creating the requested index would require FDA to create screen shots for each section, as it did for the
index it provided in November. Given the nature of the documents in these sections, FDA anticipates
that there would likely be confidential information in section titles, such that they could not be shared
with PHMPT. Again, FDA assess that it cannot reasonably divert resources away from its processing
efforts to this task at this time, in light of those circumstances.
Thanks,
Toni
Antonia Konkoly
Trial Attorney
U.S. Department of Justice
Civil Division | Federal Programs Branch
Direct line: (202) 514-2395
email: [email protected]
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Exhibit 4
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From: Mike Kroeber - BIA < [email protected] >
Sent: Friday, December 10, 2021 8:20 PM
To: Nicky Tenney <[email protected] >
Subject: Review Pricing as requested
Hi Nicky,
The following is a breakdown of the pricing you requested for the Siri Glimstad
project we spoke about earlier today. I’ve included some assumptions that
we made based on the discussion we had this afternoon. Please review what
I’ve included and let me know if you have any questions.
I will add that we have quite a bit of experience in IP and Medical andHealthcare related matters, having just finished a 30TB review last week whichconsisted of about 15 million or so pages of documents.
So we are well skilled
in dealing with this topic.
If you have any questions at all with the below, feel free to reach out.
Our pricing is as follows:
Known Information:
400,000 pages
PDF & Excel Files
Redacting for Trade Secret & PHI
Privilege Log required
Assumptions:
400,000 pages = 65,000 documents = 75GB
Estimate 25% (100,000 pages / 16,250 documents) will be fully automated
redactions
Estimate 75% (300,000 pages / 48,750 documents) will require manualredactions
Estimate 1,700 hours of manual review
Estimate 50 hour Team Lead
Estimate 6-8 weeks
Item Quantity Price Per Unit Total
PM Time 20 hours $175/Hr. $3,500
•
•
•
•
•
•
•
•
•
•
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Data Processing 75 GB $60/GB $4,500
Relativity Site
Setup1 Time $500 $500
Relativity Hosting 75GB $8/Mo. $600/Mo.
Relativity Users 10 $85/Mo. $850/Mo.
Blackout 16,250 documents $.75/Doc. $12,187
AttorneyReviewers1,700 hours $50/Hr. $85,000
Review TeamLead50 hours $95/Hr. $4,750
Data Technician 20 hours $150/Hr. $3,000
Productions 400,000 pages 0.03/Pg. $12,000
Privilege Log 1 $2500 Flat Fee $2,500
Advisory Expert 10 hours $300/Hr. $3,000
Estimated Project Total - $132,387
As I mentioned, I’ve made my best attempt at the pricing based on theinformation known to me at this time and I’ve tried to be conservative in myestimates. The assumptions I’ve used are provided above.
Once we receive
the data and better understand the overall makeup of the collection, we maybe able to further refine the assumptions, and even potentially reduce theoverall cost estimates.
We anticipate that this project would take 6-8 weeks to complete, with ateam of 10 reviewers and 1 team leader.
We could shorten that time frame
somewhat with additional reviewers if needed. We should be able to start the
project fairly quickly, with the data collection and processing takingapproximately 3-4 days, along with the time to prepare and set up theRelativity site and the Review starting directly after.
We would charge no extra fee for starting earlier or later.
As we mentioned on the call, if we are able to automate more of the process,if the data set lends itself to using Blackout to do more of the redactions, thecost and the time frame would be reduced significantly, but we won’t know ifthat’s possible until we see a sample set of data.
Again, thank you for allowing us to present pricing for this project, and I lookforward to speaking with you and the team, and answering any questions youall might have.
Have a great night and a great weekend if I don’t speak with you before.
Michael Kroeber, CEDS
National Account Director | BIA
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D: 646.843.2266 | M: 516. 263.2040 | F: 212.240.2298
[email protected]
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Exhibit 5
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Vital Statistics Rapid Release
Report No . 010 February 2021
Provisional Life Expectancy Estimates for
January through June, 2020
Elizabeth Arias, Ph.D., Betzaida Tejada-Vera, M.S., and Farida Ahmad, M.P.H.
U.S. Department of Health and Human Services • Centers for Disease Control and Prevention • National Center for Health Statistics • National Vital Statistics System
NCHS reports can be downloaded from: https://www.cdc.gov/nchs/products/index.htm .Introduction
The National Center for Health
Statistics (NCHS) collects and
disseminates the nation’s official vital statistics through the National Vital Statistics System (NVSS). NCHS uses provisional vital statistics data for conducting public health surveillance and final data for producing annual national natality and mortality statistics. NCHS publishes annual and decennial national life tables based on final vital statistics. In order to assess the effects on life expectancy of excess mortality observed during 2020, NCHS is publishing, for the first time, life tables based on provisional vital statistics data. Provisional data are early estimates based on death certificates received, processed, and coded but not finalized by NCHS. These estimates are considered provisional because death certificate information may later be revised and additional death certificates may be received until approximately 6 months after the end of the data year.
This report presents life expectancy
estimates based on provisional death counts for the months January through June, 2020, by sex, for the total, Hispanic, non-Hispanic white, and non-Hispanic black populations. Abridged period life tables calculated to produce the provisional life expectancy estimates are also provided via Internet tables (see Technical Notes and Internet tables
1–15 ). Life expectancy estimates based
on final data for 2019 by sex, Hispanic origin, and race are also provided in this report for purposes of comparison (see Technical Notes and reference 1 for
description of methodology). Keywords: life expectancy • Hispanic
origin • race • National Vital Statistics System
Data and Methods
Provisional life expectancy estimates
were calculated using abridged period life tables based on provisional death counts for the first half of 2020 from death records received and processed by NCHS as of October 26, 2020; provisional numbers of births for the same period based on birth records received and processed by NCHS as of October 27, 2020; and, April 1, 2020 monthly postcensal population estimates based on the 2010 decennial census. Provisional mortality rates are typically computed using death data after a 3-month lag following date of death, as completeness and timeliness of provisional death data can vary by many factors, including cause of death, month of the year, and age of the decedent (2,3). Mortality data used in this report include over 99% of the deaths that occurred from January through June, 2020, but certain jurisdictions and age groups may be underrepresented for the latter months in the period (3). Deaths requiring investigation, including infant deaths, deaths from external injuries, and drug overdose deaths may be underestimated (4,5). See Technical Notes for more
information about the calculation of the abridged period life tables and 2019 life expectancy estimates by race and Hispanic origin.Results
Life expectancy in the United
States
The Table summarizes life expectancy
by age, H
ispanic origin, race, and sex.
Life expectancy at birth represents the
average number of years that a group of infants would live if they were to experience throughout life the age-specific death rates prevailing during a specified period. In the f
irst half of
2020, life expectancy at birth for the total U.S. population was 77.8 years, declining by 1.0 year from 78.8 in 2019 (6). L
ife expectancy at birth for males
was 75.1 years in the first half of 2020, representing a decline of 1.2 years from 76.3 years in 2019. For females, life expectancy declined to 80.5 years, decreasing 0.9 year from 81.4 years in 2019 ( Figure
1).
The difference in life expectancy
between the sexes was 5.4 years in the first half of 2020, increasing from 5.1 in 2019. Between 2000 and 2010, the difference in life expectancy between the sexes narrowed from 5.2 years to its lowest level of 4.8 years and then gradually increasing to 5.1 years in 2019 (Figure 1 ).
Life expectancy by Hispanic
origin and race
Between 2019 and the first half
of 2020, life expectancy decreased
2.7 years for the non-Hispanic black population (74.7 to 72.0) ( Figure 2 ). It
decreased by 1.9 years for the Hispanic population (81.8 to 79.9) and by 0.8 year for the non-Hispanic white population ..............
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U.S. Department of Health and Human Services • Centers for Disease Control and Prevention • National Center for Health Statistics • National Vital Statistics System2
Vital Statistics Surveillance Report070758085Female
MaleTotal
2020 2018 2016 2014 2012 2010 2008 2006 2004 2002 2000Age (years)Figure 1. Life expectancy at birth, by sex: United States, 2000–2020
NOTES: Life expectancies for 2019 by Hispanic origin and race are not final estimates; see Technical Notes. Estimates are based
on provisional data from January 2020 through June 2020.SOURCE: National Center for Health Statistics, National Vital Statistics System, Mortality data.
(78.8 to 78.0). In the first half of 2020,
the Hispanic population had a life expectancy advantage of 1.9 years over the non-Hispanic white population, declining from an advantage of 3.0 years in 2019 ( Figure 3 ). The Hispanic
advantage relative to the non-Hispanic black population increased from 7.1 to 7.9 years between 2019 and the first half of 2020. The non-Hispanic white life expectancy advantage relative to the non-Hispanic black population increased from 4.1 to 6.0 years between 2019 and the first half of 2020. Among the six Hispanic origin and
race-sex groups ( Figure 4 ), the decrease
in life expectancy between 2019 and the first half of 2020 was highest for non-Hispanic black males whose life expectancy declined by 3.0 years (71.3 to 68.3), followed in order by Hispanic males with a decline of 2.4 years (79.0 to 76.6), non-Hispanic black females with a decline of 2.3 years (78.1 to 75.8), Hispanic females with a decline of 1.1 years (84.4 to 83.3), non-Hispanic white males with a decline of 0.8 year (76.3 to 75.5), and non-Hispanic white females with a decline of 0.7 year (81.3 to 80.6).
Discussion and Conclusions
Provisional life expectancy at birth in
the first half of 2020 was the lowest level since 2006 for both the total population (77.8 years) and for males (75.1), and was
t
he lowest level since 2007 for females
(80.5). Life expectancy for the non-Hispanic black population, 72.0, declined the most, and was the lowest estimate seen since 2001 (for the black population regardless of Hispanic origin). The Hispanic population experienced the Table. Expectation of life by age, Hispanic origin, race for the non-Hispanic population, and sex: United States, 2020
All origins Hispanic1Non-Hispanic white1Non-Hispanic black1
Age (years) Total Male Female Total Male Female Total Male Female Total Male Female
0 77.8 75.1 80.5 79.9 76.6 83.3 78.0 75.5 80.6 72.0 68.3 75.8
1 77.2 74.5 80.0 79.3 76.0 82.7 77.4 74.9 79.9 71.8 68.1 75.5
5 73.3 70.6 76.0 75.4 72.1 78.8 73.4 71.0 75.9 67.9 64.2 71.6
10 68.3 65.6 71.0 70.4 67.1 73.8 68.4 66.0 71.0 63.0 59.3 66.7
15 63.4 60.7 66.1 65.4 62.1 68.8 63.5 61.1 66.0 58.1 54.4 61.7
20 58.5 55.9 61.2 60.6 57.3 63.9 58.6 56.3 61.1 53.4 49.8 56.9
25 53.8 51.3 56.3 55.8 52.7 59.1 53.9 51.6 56.3 48.9 45.5 52.1
30 49.2 46.8 51.5 51.1 48.1 54.2 49.2 47.0 51.5 44.4 41.1 47.4
35 44.6 42.3 46.8 46.5 43.5 49.4 44.6 42.6 46.7 39.9 36.8 42.8
40 40.0 37.8 42.1 41.8 39.0 44.6 40.1 38.1 42.1 35.5 32.6 38.3
45 35.5 33.4 37.5 37.3 34.6 39.9 35.6 33.7 37.4 31.3 28.5 33.9
50 31.1 29.2 33.0 32.8 30.2 35.2 31.2 29.4 32.9 27.2 24.6 29.6
55 26.9 25.1 28.6 28.5 26.1 30.7 26.9 25.3 28.5 23.3 20.8 25.5
60 22.9 21.3 24.4 24.4 22.2 26.4 22.9 21.5 24.3 19.7 17.5 21.7
65 19.1 17.8 20.4 20.6 18.7 22.3 19.1 17.9 20.2 16.5 14.5 18.1
70 15.5 14.4 16.5 17.0 15.4 18.3 15.4 14.4 16.3 13.6 11.9 14.8
75 12.2 11.3 12.9 13.7 12.4 14.6 12.0 11.2 12.7 10.8 9.6 11.8
80 9.3 8.6 9.7 10.7 9.8 11.4 9.0 8.4 9.5 8.5 7.5 9.1
85 6.8 6.4 7.0 8.3 7.7 8.8 6.5 6.1 6.7 6.5 5.9 6.8
1Life tables by Hispanic origin are based on death rates that have been adjusted for race and ethnicity misclassification on death certificates. Updated classification ratios were applied; see Technical Notes.
NOTES: Estimates are based on provisional data from January 2020 through June 2020. Provisional data are subject to change as additional data are received.
SOURCE: National Center for Health Statistics, National Vital Statistics System, Mortality, 2020.
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U.S. Department of Health and Human Services • Centers for Disease Control and Prevention • National Center for Health Statistics • National Vital Statistics System3
Vital Statistics Surveillance Report070758085
81.8
79.9
78.8
78.0
74.7
72.0 Non-Hispanic black Non-Hispanic white HispanicAge (years)2019 2020Figure 2. Life expectancy at birth, by Hispanic origin and race: United States, 2019 and 2020
NOTES: Life expectancies for 2019 by Hispanic origin and race are not final estimates; see Technical Notes. Estimates are based
on provisional data from January 2020 through June 2020.SOURCE: National Center for Health Statistics, National Vital Statistics System, Mortality data.
0 2 4
Age (years)6 8Non-Hispanic white and
non-Hispanic blackHispanic and
non-Hispanic whiteHispanic and
non-Hispanic black7.1
7.9
3.0
1.9
4.1
6.0Figure 3. Differences between groups in life expectancy at birth: United States, 2019 and 2020
NOTES: Life expectancies for 2019 by Hispanic origin and race are not final estimates; see Technical Notes. Estimates are based on provisional data from January 2020 through June 2020.SOURCE: National Center for Health Statistics, National Vital Statistics System, Mortality data.2019
2020
second largest decline in life expectancy
(79.9) reaching a level lower than what it was in 2006, the first year for which life expectancy estimates by Hispanic origin were produced (80.3). The levels observed for the non-Hispanic white population were last seen in 2005 for the white population (regardless of Hispanic origin) (7). Another consequence of the decreased
life expectancy estimates observed during the first half of 2020 was a worsening of racial and ethnic mortality disparities. For example, the gap in life expectancy at birth between the non-Hispanic black and white populations increased by 46% between 2019 and the first half of 2020 (from 4.1 to 6.0 years). Regardless of Hispanic origin, life expectancy for the black population has consistently been lower than that of the white population but the gap between the two races had generally been narrowing since 1993 when it was 7.1 (7). The gap of 6.0 observed in the first half of 2020 is the largest since 1998 (7).
Conversely, the gap between the
Hispanic and non-Hispanic white populations decreased by 37% between 2019 and the first half of 2020 (from 3.0 to 1.9 years). This indicates that the Hispanic population lost some of the mortality advantage it has evidenced since 2006 relative to the non-Hispanic white population, despite experiencing generally lower socioeconomic status (8–10).
The provisional life expectancy
estimates presented in this report are subject to important limitations. First, they are based on deaths that occurred during the first 6 months of the year and do not reflect the entirety of the effects of the COVID-19 pandemic in 2020, or other changes in causes of death, such as the increases in provisional drug overdose deaths through early 2020 (11). There is seasonality in death patterns in any given year, with winter months typically seeing more deaths than summer months, and this is not accounted for in the data. Second, the COVID-19 pandemic differentially affected certain geographic areas in the first half of 2020. The life table estimates may disproportionately represent mortality in those regions, which are more urban and have different demographic characteristics than areas affected by the pandemic in the latter part of the year. As a result, life expectancy at birth for the first half of 2020 may be underestimated since the populations more severely affected, Hispanic and non-Hispanic black populations, are more likely to live in urban areas.
The provisional mortality data on
which the life tables are based also have a number of limitations. First, the timeliness of death certificate data varies by jurisdiction. Some jurisdictions --
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U.S. Department of Health and Human Services • Centers for Disease Control and Prevention • National Center for Health Statistics • National Vital Statistics System4
Vital Statistics Surveillance Report-4-3-2-10Change (years)Hispanic
femaleNon-Hispanic
white femaleNon-Hispanic
black femaleHispanic
maleNon-Hispanic
black maleNon-Hispanic
white male
-3.0-2.4 -2.3-1.1-0.8-0.7Figure 4. Change in life expectancy at birth, by Hispanic origin and race and sex: United States,
2019 and 2020
NOTES: Life expectancies for 2019 by Hispanic origin and race are not final estimates; see Technical Notes. Estimates are based
on provisional data from January 2020 through June 2020.SOURCE: National Center for Health Statistics, National Vital Statistics System, Mortality data.
have historically taken longer to
submit death certificates because of paper records, staffing shortages, or other localized issues. More recently, jurisdictions were differently affected by the pandemic. Many jurisdictions increased their frequency of death certificate submissions, while some faced staffing challenges, data processing disruptions, or other issues. Some jurisdictions expanded their use of electronic death registration systems in 2020, which may have affected the timeliness of data submission. The effect of recent changes in timeliness will not be apparent until data are finalized. Another limitation is the variation in timeliness due to age and cause of death. Certain age groups, particularly under 5 years, may be underrepresented (3). Completion of death certificates takes longer for deaths from causes requiring investigation, including infant deaths, external injuries, and drug overdose deaths. As a result, these deaths may be underreported in the three to six months after the death occurred. Lastly, the timeliness of death certificate data by race or ethnicity has not been studied. Differences in timeliness by these factors may result in underestimation of deaths for specific groups. The underestimation of infant deaths, for example, will have a disproportionate effect on life expectancy at birth given that infant mortality has a large effect on life expectancy at birth due to it generally being higher than mortality at all other ages up to the mid-50s or so.
References
1.Arias E, Xu JQ. United States life
tables, 2018. National Vital Statistics
Reports; vol 69, no 12. Hyattsville,
MD: National Center for Health
Statistics. 2020. Available from:
https://www.cdc.gov/nchs/data/nvsr/
nvsr69/nvsr69-12-508.pdf.
2.Ahmad FB, Bastian B. Quarterly
provisional estimates for selected
indicators of mortality, 2018 –
Quarter 2, 2020. National Center for
Health Statistics. National Vital
Statistics System, Vital Statistics
Rapid Release Program. 2020.
Available from: https://www.cdc.
gov/nchs/nvss/vsrr/mortality.htm .
3.Ahmad FB, Dokpesi P, Escobedo L,
Rossen L. Timeliness of death
certificate data by sex, age, and
geography.
Vital Statistics Rapid
Release; no 9. Hyattsville, MD:
National Center for Health Statistics.June 2020. Available from:
https://www.cdc.gov/nchs/data/vsrr/
vsrr009-508.pdf.
4.Rossen LM, Ahmad FB, SpencerMR, Warner M, Sutton P. Methodsto adjust provisional counts of drugoverdose deaths for underreporting.Vital Statistics Rapid Release; no 6.Hyattsville, MD: National Centerfor Health Statistics. 2018. Availablefrom: https://www.cdc.gov/nchs/data/vsrr/report006.pdf .
5.Rossen LM, Womack LS, SpencerMR, Ahmad FB. Timeliness of infant death data for infantmortality surveillance and quarterlyprovisional estimates. Vital StatisticsRapid Release; no 5. Hyattsville,MD: National Center for HealthStatistics. 2018. Available from:https://www.cdc.gov/nchs/data/vsrr/report005.pdf.
6.Kochanek K, Xu JQ, Arias E.Mortality in the United States, 2019.Data Brief, no 395. Hyattsville, MD:National Center for Health Statistics.2020. Available from: https://
www.cdc.gov/nchs/data/databriefs/db395-H.pdf.
7.Arias E, Xu JQ. United States lifetables, 2017. National Vital StatisticsReports; vol 68, no 7. Hyattsville,MD: National Center for HealthStatistics. 2019. Available from:https://www.cdc.gov/nchs/data/nvsr/nvsr68/nvsr68_07-508.pdf.
8.Arias E, Heron M, Hakes JK. Thevalidity of race and Hispanic-originreporting on death certificates in theUnited States: An update. NationalCenter for Health Statistics. VitalHealth Stat 2(172). 2016. Availablefrom: http://www.cdc.gov/nchs/data/series/sr_02/sr02_172.pdf.
9.Arias E. United States life tables byHispanic origin. National Center forHealth Statistics. Vital Health Stat2(152). 2010. Available from: http://
www.cdc.gov/nchs/data/series/sr_02/sr02_152.pdf.
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U.S. Department of Health and Human Services • Centers for Disease Control and Prevention • National Center for Health Statistics • National Vital Statistics System5
Vital Statistics Surveillance Report10. Markides KS, Coreil J. The health of
Hispanics in the southwestern United States: An epidemiologic paradox. Public Health Rep 101(3):253–65. 1986.
11. Ahmad FB, Rossen LM, Sutton P. Provisional drug overdose death counts. National Center for Health Statistics. 2020. Available from: https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm .
12. Chiang CL. The life table and its applications. Malabar, FL: R.E. Krieger Publishing Company. 1984.
13. Silcocks PBS, Jenner DA, Reza R. Life expectancy as a summary of mortality in a population: Statistical considerations and suitability for use by health authorities. J Epidemiol Community Health 55:38–43. 2001.
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U.S. Department of Health and Human Services • Centers for Disease Control and Prevention • National Center for Health Statistics • National Vital Statistics System6
Vital Statistics Surveillance ReportTechnical Notes
The methodology used to estimate
the provisional 2020 life tables ( Internet
tables 1–12 ) on which the life expectancy
estimates presented in this report are
based differs from what is used to estimate the annual U.S. national life tables in several ways (1). First, the life tables presented in this report are based on provisional death counts for half a year rather than on final death counts for a full year. Second, they are based on monthly population estimates rather than annual mid-year population estimates. Third, they are abridged period life tables closed at ages 85 and over rather than complete period life tables closed at ages 100 and over. The main reason for the differences in methodology is data availability. Final death counts for the year 2020 will be not be available until late 2021. Similarly, census mid-year population estimates for 2020 are not yet available. The tables are closed at ages 85 and over because Medicare data, used to supplement vital statistics data at older ages, will not be available until mid-2021. Another difference is the use of provisional birth counts for the first half of 2020 rather than final birth counts and linked birth/infant death data used for life tables by Hispanic origin and race as these data are not yet available. Finally, abridged rather than complete life tables were used to address the effects of small death counts for some Hispanic origin-race-sex-age groups ( Internet tables
1–12).
Standard errors of the two most
important functions, the probability of dying and life expectancy ( Internet
tables 13–14 ), are estimated under
the assumption that the data are only affected by random error because over 99% of deaths that occurred during the first half of 2020 are included. However, the possibility that certain jurisdictions and age groups may be underrepresented for later months in the period could potentially lead to biases not accounted for by the estimated standard errors. Other possible errors, including age, and Hispanic origin and race misreporting on death certificates are also not considered in the calculation of the variances or standard errors of the life table functions.
Life expectancy estimates presented
in this report for 2019 are based on 2019 complete period life tables generated using the same methodology as that used each year to estimate annual U.S. life tables, with a minor modification (1). The standard 2018 and 2019 birth and 2019 mortality data files were used rather than the 2019 linked birth/infant death data file because the latter is not yet available. The final 2019 life tables by Hispanic origin and race will be updated once the linked birth/infant death data are available ( Internet table 15 ).
Data for calculating life table
functions
Vital statistics data
Mortality data used to estimate the life
tables presented in this report include
over 99% of the deaths that occurred from January through June, 2020, although certain jurisdictions and age groups may be underrepresented for later months in the period. Death data are typically over 99% complete 3 months after the date of death, but this can vary by jurisdiction, age of the decedent, and the cause of death. Most jurisdictions submit over 90% of death data by 3 months after the date of death, but some jurisdictions may take longer to submit death records. Death data for decedents under age 5 years are 90% complete 3 months after the date of death, and 95% complete by 6 months after the death occurred. Infant death records often take longer to complete because infant deaths often require additional investigation. As a result, provisional estimates of infant mortality are typically presented with a nine-month lag after death. Timeliness also varies by cause of death, with deaths due to external causes taking additional time to investigate and complete death certificates. Provisional estimates for most external causes of death (e.g., falls, suicides, unintentional injuries, etc.) are presented with a 6-month lag, while drug overdose deaths are presented with a 9-month lag.Beginning with the 2018 data year, all
50 states and D.C. reported deaths based on the 2003 revision of the U.S. Standard Certificate of Death for the entire year (1). The revision is based on the 1997 Office of Management and Budget (OMB) standards (1). The 1997 standard allows individuals to report more than one race and increased the race choices from four to five by separating the Asian and Pacific Islander groups. The Hispanic category did not change, remaining consistent with previous reports.
The Hispanic origin and race groups
in this report follow the 1997 standards and differ from the race categories used in reports for data years prior to 2018. From 2003–2017, not all deaths were reported using the 2003 certificate revision that allowed the reporting of more than one race based on the 1997 OMB race standard (1). During those years, multiple-race data were bridged to the 1977 standard single-race categories. Use of the bridged-race process was discontinued for the reporting of mortality statistics in 2018 when all states collected data on race according to 1997 OMB guidelines for the full data year.
Census population data
The population data used to estimate
the life tables shown in this report are April 1, 2020 monthly postcensal population estimates based on the 2010 decennial census and are available from the U.S. Census website at https://www.census.gov/data/tables/time-series/demo/popest/2010s-national-detail.html .
Preliminary adjustment of
the data
Adjustments for unknown age
An adjustment is made to account
for the small proportion of deaths for
which age is not reported on the death certificate. The number of deaths in each age category is adjusted proportionally to account for those with not-stated ages. The following factor ( F) is used to make
the adjustment. F is calculated for the
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U.S. Department of Health and Human Services • Centers for Disease Control and Prevention • National Center for Health Statistics • National Vital Statistics System7
Vital Statistics Surveillance Reporttotal and for each sex group within a
racial and ethnic population for which life tables are constructed:
FD D
a=/
where D is the total number of deaths and D
a is the total number of deaths for
which age is stated. F is then applied by multiplying it by the number of deaths in each age group.
Adjustment for misclassification
of Hispanic origin and race on death certificates
The latest research to evaluate
Hispanic origin and race reporting on
U.S. death certificates found that the misclassification of Hispanic origin and race on death certificates in the United States accounts for a net underestimate of 3% for total Hispanic deaths, a net underestimate of less than one-half percent for total non-Hispanic black deaths, and no under or overestimate for total non-Hispanic white deaths (8). These results are based on a comparison of self-reported Hispanic origin and race on Current Population Surveys (CPS) with Hispanic origin and race reported on the death certificates of a sample of decedents in the National Longitudinal Mortality Study (NLMS) who died during the period 1999–2011 (8).
NLMS-linked records are used to
estimate sex-age-specific ratios of CPS Hispanic origin and race counts to death certificate counts (9). The CPS/death certificate ratio, or “classification ratio,” is specifically the ratio of the weighted count of self-reported race and ethnicity on the CPS to the weighted count of the same racial or ethnic category on the death certificates of the sample of NLMS decedents described above. It can be interpreted as the net difference in assignment of a specific Hispanic origin and race category between the two classification systems and can be used as a correction factor for Hispanic origin and race misclassification (8). The assumption is made that the race and ethnicity reported by a CPS respondent is more reliable than proxy reporting of race and ethnicity by a funeral director who has little personal knowledge of the decedent. Further, public policy embodied in the 1997 OMB standard mandates that self-identification should be the standard used for the collection and recording of race and ethnicity information (8).
The NLMS-based classification ratios
discussed above are used to adjust the age-specific number of deaths for ages 1–85 years and over for the total, Hispanic, non-Hispanic white, and non-Hispanic black populations, and by sex for each group, as follows:
nx nxF
nx DD CR
where nDxF is the age-specific number
of deaths adjusted for unknown age as described above,
nCRx are the sex- and
age-specific classification ratios used to correct for the misclassification of Hispanic origin and race on death certificates, and
nDx are the final
age-specific counts of death adjusted for age and Hispanic origin and race misclassification.
Because NLMS classification ratios
for infant deaths are unreliable due to small sample sizes, corrections for racial and ethnic misclassification of infant deaths are addressed by using infant death counts and live birth counts from the linked birth/infant death data files rather than the traditional birth and death data files (1). In the linked file, each infant death record is linked to its corresponding birth record so that the race and ethnicity of the mother reported on the birth record can be ascribed to the infant death record. Due to the unavailability of birth/infant death data at this time, the traditional birth and death data files are used instead for both the 2019 and 2020 life tables. Typically, infant mortality rates based on these data are overestimated by approximately 4% for the Hispanic population and 3% for the non-Hispanic black population and underestimated by 2% for the non-Hispanic white population (1).Calculation of abridged life
tables
Abridged life tables were constructed
using the methodology developed
by Chiang with minor modifications described below (12). The life table columns include:
Age
The age interval between two exact
ages, x and x + n . The abridged life tables
contain 19 age groups (in years): 0–1, 1–5, 5–10, 10–15, …, 80–85, and 85 and over.
Probability of dying, nqx
The first step in the calculation of
an abridged period life table is the estimation of the age-specific probability of dying,
nqx. The probability of dying
between two exact ages, x and x + n , is
defined as:
n
xxxx nx
nxqnM
M an 11()
where nMx is the age-specific period
death rate, nx
nxD
P1
2, and nDx is the
age-specific provisional death count for
January through June, nPx is the April 1,
2020 age-specific monthly population estimates based on the 2010 decennial population census population count; n
x is
the size in years of the age interval; and a
x is the fraction of life lived by those
who died in the age interval.
Number surviving, lx
The number of persons surviving to
the beginning of the age interval from the original 100,000 hypothetical live births is defined as:
ll dxn x nx
where the radix of the table l0 = 100,000.
Number dying, ndx
The number of persons dying in the
hypothetical life table cohort in the age-interval x and x + n is defined as:
nx xn x dl q•
•
+ • •
•-
+
•
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U.S. Department of Health and Human Services • Centers for Disease Control and Prevention • National Center for Health Statistics • National Vital Statistics System8
Vital Statistics Surveillance ReportPerson-years lived, nLx
The number of person-years lived by the hypothetical life table cohort within an age
interval x and x + n is defined as:
where 85+Lx, the person-years lived in the final open-ended age interval, is defined as:
Total number of person-years lived, Tx
The number of person-years that would be lived by the hypothetical life table cohort
after the beginning of the age interval x and x + n is defined as:
Expectation of life, ex
The average number of years to be lived by those in the hypothetical life table cohort
surviving to age x is defined as:
Variances and standard errors of the probability of dying and life
expectancy
Variances are estimated under the assumption that the mortality data on which
the life tables are based are not affected by sampling error and subject only to
random variation. However, although over 99% of deaths that occurred from January through June, 2020 are included, the data may be biased by the possibility that certain jurisdictions and age groups may be underrepresented for later months in the period. These errors as well as those resulting from age, Hispanic origin and race misreporting on death certificates are not considered in the calculation of the variances or standard errors of the life table functions.
The methods used to estimate the variances of
nqx and ex are based on Chiang (12)
with a minor modification in the estimate of the variance of ex in the closing age of the
life table (13). Based on the assumption that deaths are binomially distributed, Chiang proposed the following equation for the variance of
nqx:
where nDx is the age-specific number of deaths, and for the variance of ex for ages
under 85:
and for ages 85 and over: Ll
Mx 85+
85+x
x
TLxn x
xx
085+
eT
lxx
x=
Varqq
Dq
nxnx nx
nx()()21nx nx nx xx xx Ld nl da n ()Acknowledgments
The authors are grateful for the content
review provided by Sherry L. Murphy, Mortality Statistics Branch (MSB). The authors thank Isabelle Horon, Division of Vital Statistics; Amy B. Branum, Office of the Directory; and Robert N. Anderson, MSB for their reviews and comments. The report was edited and produced by NCHS Office of Information Services, Information Design and Publishing Staff: Yolanda L. Jones and Michael Jones.
Suggested citation
Arias E, Tejada-Vera B, Ahmad F.
Provisional life expectancy estimates for January through June, 2020. Vital Statistics Rapid Release; no 10. Hyattsville, MD: National Center for Health Statistics. February 2021. DOI: https://dx.doi.org/10.15620/cdc:100392 .
Copyright information
All material appearing in this report
is in the public domain and may be reproduced or copied without permission; citation as to source, however, is appreciated.
National Center for Health Statistics
Brian C. Moyer, Ph.D., Director
Amy M. Branum, Ph.D., Acting
Associate Director for Science
Division of Vital Statistics
Steven Schwartz, Ph.D., Director
Isabelle Horon, Dr.P.H., Acting Associate
Director for Science
CS322201• + • •
x=75-84 L l; •[(1-aJ•nx +e(x+n/ •Var(nqx)
Var(ex) = _x_=O ______________ _
z2
X
( ) ifs+ ( ) Var e85+ = --4 - • Var M85+
Mss+
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Exhibit 6
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Prescription Drug User Fee Amendments
Latest News:
On August 16, 2021, the Food and Drug Administration announced the Prescription
Drug User Fee Rates for Fiscal Year 2022
(https://www.federalregister.gov/documents/2021/08/16/2021-17505/prescription-
drug-user-fee-rates-for-fiscal-year-2022) in the Federal Register for fees assessed
under the Federal Food, Drug, and Cosmetic Act. These fees apply to the period from
October 1, 2021, through September 30, 2022. Please see the table below for Fiscal
Year 2021 and Fiscal Year 2022 fee rates.
The FY 2022 PDUFA program fee invoices were emailed on Friday, August 20,
2021. Full payment of the invoice is due October 01, 2021. If you do not receive your
invoice by August 25, 2021, please contact PDUFA User Fee staff
at [email protected] (mailto:[email protected]).
CDER’s Work to Meet User Fee Goals During the Pandemic (/industry/fda-user-fee-
programs/cders-work-meet-user-fee-goals-during-pandemic/?
utm_source=GDUFA&utm_medium=web&utm_campaign=FDA) : This webpage will
provide periodic updates on key user fee metrics related to application review and the
pre-approval process throughout the COVID-19 pandemic.
IMPORTANT NOTICE REGARDING PRESCRIPTION DRUG USER FEE STAFF
CONTACT INFORMATION: Due to the COVID-19 pandemic, and until further notice,
electronic mail is the Prescription Drug User Fee staff’s preferred method of receiving
communication over postal mail. If you have questions or documentation for the
Prescription Drug User Fee staff regarding PDUFA Fee requirements, waivers,
reductions or refunds, please send them by electronic mail to
[email protected] (mailto:[email protected]). Please
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FY 2021 and FY 2022 User Fee Rates:
User Fee Type 2021 2022
Application Fee – Clinical Data Required $2,875,842 $3,117,218•
•
•
•
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User Fee Type 2021 2022
Application Fee – No Clinical Data Required $1,437,921 $1,558,609
Program Fee $336,432 $369,413
Background and Legislation
The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and
authorizes FDA to collect fees from companies that produce certain human drug and
biological products. Since the passage of PDUFA, user fees have played an important role in
expediting the drug approval process.
PDUFA must be reauthorized every five years, and was renewed in 1997 (PDUFA II
(/industry/prescription-drug-user-fee-act-pdufa/pdufa-legislation-and-background-pdufa-
ii)), 2002 ( PDUFA III (/industry/prescription-drug-user-fee-act-pdufa/pdufa-legislation-
and-background-pdufa-iii) ), 2007 ( PDUFA IV (/industry/prescription-drug-user-fee-act-
pdufa/pdufa-legislation-and-background-pdufa-iv) ), and 2012 ( PDUFA V
(/industry/prescription-drug-user-fee-act-pdufa/pdufa-v-fiscal-years-2013-2017) ) and
2017 ( PDUFA VI (/industry/prescription-drug-user-fee-act-pdufa/pdufa-vi-fiscal-years-
2018-2022) ). On August 18, 2017, the President signed into law the Food and Drug
Administration Reauthorization Act (FDARA), which includes the reauthorization of
PDUFA through September 2022. PDUFA VI (/industry/prescription-drug-user-fee-act-
pdufa/pdufa-vi-fiscal-years-2018-2022) will provide for the continued timely review of new
drug and biologic license applications.
Federal Register Documents and Guidances
Federal Register Documents
Fee Rate for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year
2021 (https://www.federalregister.gov/documents/2020/10/07/2020-22186/fee-
rate-for-using-a-rare-pediatric-disease-priority-review-voucher-in-fiscal-year-2021)
Fee Rate for Using a Tropical Disease Priority Review Voucher in Fiscal Year 2022
(https://www.federalregister.gov/documents/2021/09/30/2021-21328/fee-rate-for-
using-a-tropical-disease-priority-review-voucher-in-fiscal-year-2022)
Fee Rate for Using a Material Threat Medical Countermeasure Priority Review
Voucher in Fiscal Year 2022
(https://www.federalregister.gov/documents/2021/09/30/2021-21317/fee-rate-for-•
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Genus Medical Technologies LLC Versus Food and Drug Administration; Request for
Information and Comments
(https://www.federalregister.gov/documents/2021/08/09/2021-16944/genus-
medical-technologies-llc-versus-food-and-drug-administration-request-for-
information-and)
Establishment of Prescription Drug User Fee Rates for Fiscal Years 1998 – present
(/industry/prescription-drug-user-fee-act-pdufa/pdufa-user-fee-rates-archive)
Guidances
Guidance Documents and MAPPs (/industry/prescription-drug-user-fee-act-
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To find older Federal Register Documents, please visit the Archive Page
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Application Fees
What is a human drug application?
PDUFA levies a user fee on certain human drug applications. Under PDUFA, the term
human drug application means an application for
approval of a new drug submitted under section 505(b) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act), or
licensure of certain biological products under section 351(a) of the Public Health
Service Act (PHS Act).
What are application fees?
Each person that submits a human drug application is assessed an application fee as
follows:
A human drug application for which clinical data (other than bioavailability or
bioequivalence studies) with respect to safety or effectiveness are required for
approval is assessed a full application fee.
A human drug application for which clinical data with respect to safety or
effectiveness are not required for approval is assessed one-half of a full fee.•
•
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Visit our Payment Information and Cover Sheet tab for all the information you will need to
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Are there any exceptions to the fee requirements?
Previously Filed Applications:
An application fee is not required for the resubmission of an application if the original
application of the same product
was submitted by a person that paid the fee for the application,
was accepted for filing, and
was not approved or was withdrawn (without a waiver).
Designated Orphan Drug or Indication
An application for a prescription drug product that has been designated as a drug for
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application fee unless the application includes an indication for other than a rare
disease or condition.
For more information about application fees, please read FDA’s guidance for industry
Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017
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Program Fees
What are prescription drug program fees?
Prescription drug program fees are assessed annually for eligible products. The program
fees are assessed for each prescription drug product that is identified in such a human drug
application approved as of October 1st of such fiscal year.
Applicants may not be assessed more than five prescription drug program fees for a fiscal
year for prescription drug products identified in a single approved application.
What is the definition of a prescription drug product?
Prescription drug product means a specific strength or potency of a drug in final dosage
form for which a human drug application has been approved and which may be dispensed
only by prescription under section 503(b) of the FD&C Act, and is also on the list of•
0
0 0
•
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Secretary of products approved under human drug applications under section 351 of the
Public Health Service Act.
Are there drugs that are not included in the term prescription drug product?
Yes. The term prescription drug product does not include the following drugs:
Whole blood or a blood component for transfusion,
A bovine blood product for topical application licensed before September 1, 1992, an
allergenic extract product, or an in vitro diagnostic biologic product licensed under
section 351 of the PHS Act,
A biological product that is licensed for further manufacturing use only,
A drug that is not distributed commercially AND is the subject of an application or
supplement submitted by a State or Federal Government entity.
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Visit our Payment Information and Cover Sheet tab for all the information you will need to
pay your program fee.
Are there any exceptions to the fee requirements?
Yes, there are. An annual program fee is not assessed if the prescription drug product is:
listed in the Orange Book with a potency described in terms of per 100 mL, or,
the same product as another product that –
was approved under an application filed under sections 505(b) or 505(j) of the
FD&C Act,
is not in the list of discontinued products compiled under section 505(j)(7) of
the FD&C Act.
For more information about program fees, please read FDA’s guidance for industry
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Payment Information and Cover Sheet
When are user fees due?
An application fee is due when the application is submitted to FDA.•
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each year using the fee schedule for the coming fiscal year. Payments are due either
on the first business day on or after October 1 of each fiscal year or the first business
day after the enactment of an appropriations Act providing for the collection and
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invoices are generally issued in mid-December of the fiscal year and the fees are
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What is the Federal government's fiscal year?
The Federal government's fiscal year begins on October 1 and ends on September 30. For
example, fiscal year 2022 begins October 1, 2021, and ends September 30, 2022.
What is the PDUFA User Fee Cover Sheet?
Form FDA 3397, the PDUFA user fee cover sheet, is designed to provide the minimum
necessary information to determine whether a fee is required for review of an application,
to determine the amount of the fee required, and to help FDA track payments. The PDUFA
Cover Sheet Form FDA 3397 should be completed for the following:
505(b) and 351(a) Original Applications
Resubmission of 505(b) and 351(a) Original Application after a Refuse to File
Resubmission of 505(b) and 351(a) Original Applications Withdrawn before the filing
date.
The form provides a cross-reference of the fee submitted for an application with the actual
application by using a unique number tracking system to assign the user fee payment
identification number (PIN). The information collected is used by FDA's Center for Drug
Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER)
to initiate the administrative screening of new drug applications and biologics license
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payments.
How do I fill out the PDUFA User Fee Cover Sheet Online?
FDA offers you the ability to complete a PDUFA User Fee Cover Sheet online and submit it
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Instructions on how to fill out the cover sheet, please visit:•
•
•
• •
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https://userfees.fda.gov/OA_HTML/PDUFACScreation.pdf
(https://userfees.fda.gov/OA_HTML/PDUFACScreation.pdf)
How do I submit payment after completing the PDUFA User Fee Cover Sheet?
A payment may be submitted electronically via the User Fees Payment Portal
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Mail payment and copy of PDUFA user fee cover sheet to:
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P.O. Box 979107
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COLE-14-14253
Silver Spring, MD 20993-0002
Note: For wire transfers, please include the user fee payment identification number (PIN),
beginning with "PD", the BLA/NDA number and ensure that the fee that your bank will
charge for the wire transfer is added to your fee payment.
Please note for payments for annual program fees, it is helpful to include the invoice sheet
that was sent to you for the annual program fees (or product or establishment fees).
If you have problems or if you are unsure on whether or not you need to file an
application with FDA or are unsure what type of application to file:
Prescription Drug User Fee Staff Contact:
[email protected] or 301-796-7900
Center for Biologics Evaluation and Research Contact:
Carla Vincent at 240-402-8177
If you need technical assistance with your cover sheet or are unsure how to
proceed:
Contact: FDA User Fee Financial Support Team at (301) 796-7200
or [email protected].
PDUFA User Fee Cover Sheet
OMB No. 0910-0297
Form FDA 3397 (03/19)
Waivers, Reductions, and Refunds
Are there any waivers of user fees?
Under section 736(d) of the FD&C Act, a waiver may be granted for one or more fees where:
a waiver or reduction is necessary to protect the public health
assessment of the user fees would present a significant barrier to innovation due to
limited resources or other circumstances, or
the applicant involved is a small business submitting its first human drug application
for review
Is there a reduction of fees for human drug applications that are refused for
filing or are withdrawn before or after filing?
Yes. The following reductions or refunds are available:
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75 percent of the application fee is refunded for any application that is refused for
filing or is withdrawn before filing.
if an application is withdrawn after it is filed, FDA may refund the fee or a portion of
the fee if no substantial work was performed on the application or supplement. FDA
has the sole discretion to refund a fee or a portion of the fee. FDA's determination
concerning a refund is not reviewable.
To be granted a waiver, the human drug applicant must submit a written request for thewaiver.
What is the timeframe for requesting a waiver, reduction, or refund of fees?
To qualify for consideration, a written request for waiver, reduction or refund must be
submitted not later than 180 days after such fee is due.
How do I request a small business waiver and refund? An applicant should
submit Form FDA 3971 (https://www.fda.gov/media/108984/download) (Small Business
Waiver and Refund Request) to [email protected]
(mailto:[email protected]) to see if they qualify for a small business waiver.
Who should I contact with questions about how to submit a waiver, refund, or
reduction request?
Please contact [email protected] (mailto:[email protected]) with
any questions about submitting your request.
Where should I send my request?
Please submit a refund or waiver request by electronic mail to the Prescription Drug User
Fee staff at [email protected]. (mailto:[email protected])
What information should I include in my request?
For more information about submitting a request for a waiver, refund or reduction request,
please read FDA’s guidance for industry User Fee Waivers, Reductions, and Refunds for
Drug and Biological Products (/media/131797/download).
Reauthorization Activities
PDUFA VII: Fiscal Year 2023 - 2027 (https://www.fda.gov/industry/prescription-
drug-user-fee-amendments/pdufa-vii-fiscal-years-2023-2027)
PDUFA VI Five-Year Financial Plan (/media/112325/download) (PDF - 480 KB)
PDUFA Meetings (/industry/prescription-drug-user-fee-act-pdufa/pdufa-meetings) •
•
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•
•
•
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PDUFA VI Information Technology Goals and Progress (/industry/prescription-drug-
user-fee-act-pdufa/pdufa-vi-information-technology-goals-and-progress)
PDUFA VI: Fiscal Years 2018 - 2022 (/industry/prescription-drug-user-fee-act-
pdufa/pdufa-vi-fiscal-years-2018-2022)
Federal Register Notice: Public Meeting on Proposed Recommendations for PDUFA
Reauthorization (https://www.federalregister.gov/documents/2016/07/19/2016-
16916/prescription-drug-user-fee-act-public-meeting-request-for-comments)
PDUFA VI Proposed Commitment Letter (/media/99140/download)
PDUFA V: Fiscal Years 2013-2017 (/industry/prescription-drug-user-fee-act-
pdufa/pdufa-v-fiscal-years-2013-2017)
Related Information
CDER & CBER Net Hiring Data (/industry/prescription-drug-user-fee-
amendments/center-drug-evaluation-and-research-center-biologics-evaluation-and-
research-net-hiring-data)
PDUFA 5 Year Financial Plan (2018) (/media/112325/download) (PDF - 540KB)
PDUFA Letters (/industry/prescription-drug-user-fee-act-pdufa/letters-pdufa)
Annual Reports and Plans (/industry/prescription-drug-user-fee-act-pdufa/pdufa-
annual-reports-and-plans)
Orange Book (http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm)
CDER Therapeutic Biologic Products List (/media/76650/download)
CBER Billable Biologics List (/media/113210/download)
PDUFA User Fee Rates Archive (/industry/prescription-drug-user-fee-act-
pdufa/pdufa-user-fee-rates-archive)
Complete Response Letter Final Rule (/drugs/laws-acts-and-rules/complete-
response-letter-final-rule)
PDUFA Financial Reports (/about-fda/user-fee-financial-reports/pdufa-financial-
reports)
Contact Us•
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Questions for the Prescription Drug User Fee staff? Contact us
at [email protected] (mailto:[email protected]) or 301-796-
7900.
Refund or waiver request? Please email them to [email protected]
(mailto:[email protected]).
Questions about making a payment or confirming the status of a
payment? Email the User Fee Helpdesk at [email protected] (mailto:[email protected]) or
call 301-796-7200.
Questions about Pay.gov? Email them at [email protected]
(mailto:[email protected]) or call 800-624-1373.
Questions about the Orange Book? Email them at [email protected]
(mailto:[email protected]) .
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Exhibit 7
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DECEMBER 13, 2021
May 21, 2021 I C. Michael White, UConn School of Pharmacy
Why is the FDA Funded in Part by the Companies It
Regulates?
Nearly half the agency's budget now comes from 'user fees' paid
by companies seeking approval for medical devices or drugs
~ --------,... ~ l--;. . r • • II ~ , •
f - ~ -·
The Food and Drug Administration has become more reliant on fees paid by companies
regulated by the agencies than on public dollars (Adobe Stock).
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he Food and Drug Administration has moved from an entirely taxpayer-funded entity to one
increasingly funded by user fees paid by manufacturers that are being regulated.
Today, close to 45% of its budget comes from these user fees that companies pay
when they apply for approval of a medical device or drug.
As a pharmacist and medication and dietary supplement safety researcher, I understand the
vital role that the FDA plays in ensuring the safety of medications and medical devices.
But I, along with many others, now wonder: Was this move a clever win-win for the
manufacturers and the public, or did it place patient safety second to corporate profitability?
It is critical that the U.S. public understand the positive and negative ramifications so the
nation can strike the right balance.
The FDA Blocks Thalidomide
Americans in the early 20th century were outraged when they found out that manufacturers
used poor-quality methods for producing food and medication, and used unsafe, ineffective
and undisclosed addictive ingredients in medications. The resulting Food, Drug and Cosmetic
Act ofl938 gave the taxpayer-funded Food and Drug Administration new authority to protect
the U.S. consumer.
One of the FDA's most shining successes occurred in the late 1950s when the agency refused
to approve thalidomide. By 1960, 46 countries allowed pregnant women to use thalidomide to
treat morning sickness, but the FDA refused on the grounds that the studies were insufficient
to demonstrate safety. Debilitating birth defects resulting from thalidomide arose in Europe
and elsewhere in 1961. President John F. Kennedy heralded the FDA in 1962 for its stance. An
FDA driven by the data -and not corporate pressure -prevented a major tragedy.
How AIDS Changed How the FDA is Funded
The FDA continued its work fully funded by U.S. taxpayers for many years until this model
was upended by a new infectious disease. The first U.S. case of HIV-induced AIDS occurred in
1981. It was rapidly spreading, with devastating complications like blindness, dementia,
severe respiratory diseases and rare cancers. Well-known sports stars and celebrities died of
AIDS-related complications. AIDS activists were incensed about long delays in getting
experimental HIV drugs studied and approved by the FDA.
°o 11 "I' in II @
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In 1992, in response to intense pressure, Congress passed the Prescription Drug User Fee Act.
It was signed into law by President George H.W. Bush.
With the act, the FDA moved from a fully taxpayer-funded entity to one funded through tax
dollars and new prescription drug user fees. Manufacturers pay these fees when submitting
applications to the FDA for drug review and annual user fees based on the number of
approved drugs they have on the market. However, it is a complex formula with waivers,
refunds and exemptions based on the category of drugs being approved and the total number
of drugs in the manufacturers portfolio.
Over time, other user fees for generic, over-the-counter, biosimilar, animal and animal
generic drugs, as well as for medical devices, were created. As time passed, the FDA's funding
has increasingly come from the industries that it regulates. Of the FDA's total US$5.9 billion
budget, 45% comes from user fees, but 65% of the funding for human drug regulatory
activities are derived from user fees. These user fee programs must be reauthorized every five
years by Congress, and the current agreement remains in effect through September 2022.
Have User Fees Worked?
The FDA and the drug or device manufacturers negotiate the user fees. They also
negotiate performance measures that the FDA has to meet to collect them, and proposed
changes in FDA processes. Performance measures include things such as how quickly the
FDA responds to meeting requests, how quickly it generates correspondence, and how long it
takes from submission of a new drug application until the FDA approves or refuses to approve
a drug or product.
Because of the additional funding generated by user fees and performance measures that the
FDA has to meet, the FDA is quicker and more willing to discuss what it wants to see in an
application with manufacturers. It also offers clearer guidance for manufacturers. In 1987, it
took 29 months from the time a new drug application was filed by the manufacturer for the
FDA to decide whether to approve a medication in the U.S. In 2014, it only took 13 months and
by 2018, it was down to 10 months.
Changes in more recent years have also increased the number of standard new drug
applications approved the first time around by the FDA from 38% in 2005 to 61 % in 2018. In
diseases where there are not many medication options for patients, the FDA has a priority
°o 11 ~ in II @
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review process, where 89% of new drug applications were approved the first time around and
the approvals were completed in eight months in 2018. All this occurred while the number of
new drug applications have been increasing over time.
Most recently, the COVID-19 pandemic has seen the FDA provide emergency use
authorization for potential treatments in a matter of weeks, not months. The infrastructure
and capacity to review the available information so rapidly is due in large part to the funding
from user fees.
While the number and speed of drug approvals have been increasing over time, so have the
number of drugs that end up having serious safety issues coming to light after FDA approval.
In one assessment, investigators looked at the number of newly approved medications that
were subsequently removed from the market or had to include a new black box warning over
16 years from the year of approval. These black box warnings are the highest level of safety
alert that the FDA can employ, warning users that a very serious adverse event could occur.
Before the user fee act was approved, 21 % of medications were removed or had new black box
warnings as compared to 27% afterwards.
Some potential reasons that more adverse effects are coming to light after drug approval
include senior FDA officials overturning scientist recommendations, a lower burden of
proof for medication approval, and more clinical data in new drug applications coming
from foreign clinical trial sites that require additional time to assess in an environment where
regulators are rushing to meet tight deadlines.
Lack of Money Limits FDA
User fees are a viable way to shift some of the financial burden to manufacturers who stand to
make money from the approval and sale of drugs in the lucrative U.S. market. Successes have
occurred and provided U.S. citizens with medication more quickly than before.
However, without careful consideration of what is being negotiated, the FDA can become
weak and ineffective, unable to protect its citizens from the next thalidomide. There are some
signs that the pendulum may be swinging too far in the direction of the manufacturers.
Additionally, while drug approval functions at the FDA are well funded, the FDA is
°o 11 ~ in II @
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insufficiently funded to protect consumers from other issues such as counterfeit
drugs and dietary supplements because they cannot collect user fees to do so. In my view,
these functions need to be identified and require additional taxpayer funding.
Originally published in The Conversation.
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°o 11 ~ in II @
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STEP-HI Study Providing Physical and Mental Strength to Older
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°o ccllliuni.tiomin:onrfiju @
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Exhibit 8
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PFIZER AND BIONTECH INITIATE
ROLLING SUBMISSION OF BIOLOGICS
LICENSE APPLICATION FOR U.S. FDA
APPROVAL OF THEIR COVID 19
VACCINE
Friday, May 07, 2021 -06:45am EST
We look forward to working with the FDA to complete this rolling
submission and support their review, with the goal of securing full
regulatory approval of the vaccine in the coming months.
NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pf=I~~ Inc. (www.P-fizer.com). (NYSE: PFE)
and BioNTech SE (www.biontech.de). (Nasdaq: BNTX) today announced the initiation of a Biologics
License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of their
mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. Data to support the BLA
will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a
request for Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by
the FDA will be set once the BLA is complete and formally accepted for review by the agency.
The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. under an Emergency Use
Authorization (EUA) granted (httgs://www.gfizer.com/news/i;2ress-release/gress-release
detail/gfizer-and-biontech-celebrate-historic-first-authorization). by the FDA on December 11, 2020.
Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S.
Submission of a BLA, which requires longer-term follow-up data for acceptance and approval, is the
next step in the rigorous FDA review process.
"We are proud of the tremendous progress we've made since December in delivering vaccines to
millions of Americans, in collaboration with the U.S. Government," said Albert Bourla, Chairman and
Chief Executive Officer, Pfizer. ''We look forward to working with the FDA to complete this rolling
submission and support their review, with the goal of securing full regulatory approval of the
vaccine in the coming months.''
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"Following the successful delivery of more than 170 million doses to the U.S. population in just a few
months, the BLA submission is an important cornerstone of achieving long-term herd immunity and
containing COVI D-19 in the future," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. 'We are
pleased to work with U.S. regulators to seek approval of our COVID-19 vaccine based on our pivotal
Phase 3 trial and follow-up data."
Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to
support Ii censure of the COVID-19 vaccine for use in individuals 16 years of age and older. This
includes the most recent analyses (htq;2s://www.P-fizer.com/news/P-ress-release/P-ress-release
detail/P-fizer-and-biontech-confirm-high-efficacy-and-no-serious). from the pivotal Phase 3 clinical
trial, where the vaccine's efficacy and favorable safety profile were observed up to six months after
the second dose. The companies will submit the required manufacturing and facility data for
licensure in the coming weeks to complete the BLA.
Pfizer and BioNTech also have submitted an application to expand the current EUA for their COVID-
19 vaccine to include individuals 12 to 15 years of age. The companies intend to submit a
supplemental BLA to support licensure of the vaccine in this age group once the required data six
months after the second vaccine dose are available.
The Pfizer-BioNTech COVID-19 Vaccine, which is bas~Cffii BioNTech proprietary mRNA technology,
was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the
European Union, and the holder of emergency use authorizations or equivalent in the United States
(together with Pfizer), United Kingdom, Canada and other countries in advance of a planned
application for full marketing authorizations in these countries.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and
Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency
Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16
years of age and older. The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency use of the medical
product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or
authorization revoked sooner. Please see Emergency Use Authorization (EUA) Fact Sheet for
Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing
Information available at www.cvdvaccine-us.com (httP-:llwww.cvdvaccine-us.com)..
AUTHORIZED USE IN THE U.S.:
The Pfizer-BioNTech COVID19 Vaccine is authorized for use under an Emergency Use Authorization
(EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe
acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
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IMPORTANT SAFETY INFORMATION FROM U.S. FDA
EMERGENCY USE AUTHORIZATION PRESCRIBING
INFORMATION:
• Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a
severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVI D-19
Vaccine.
• Appropriate medical treatment used to manage immediate allergic reactions must be
immediately available in the event an acute anaphylactic reaction occurs following
administration of Pfizer-BioNTech COVID-19 Vaccine.
• Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse
reactions according to the Centers for Disease Control and Prevention guidelines
(httP-s://www.cdc.gov/vaccines/covid-19/ (httP-s://www.cdc.gov/vaccines/covid-19/)).
• lmmunocompromised persons, including individuals receiving immunosuppressant therapy,
may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine.
• The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.
• In clinical studies, adverse reactions in participants 16 years of age and older included pain at the
injection site (84.1 %), fatigue (62.9%), headache (55.1 %), muscle pain (38.3%), chills (31.9%), joint
pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea
(1.1 %), malaise (0.5%), and lymphadenopathy (0.3%).
• Severe allergic reactions, including anaphylaxis, have been reported following the Pfizer
BioNTech COVI D-19 Vaccine during mass vaccination outside of clinical trials.
• Additional adverse reactions, some of which ma}1 ... \U:l~erious, may become apparent with more
widespread use of the Pfizer-BioNTech COVI D-19 Vaccine.
• Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are
insufficient to inform vaccine-associated risks in pregnancy.
• Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the
breastfed infant or on milk production/excretion.
• There are no data available on the interchangeability of the Pfizer-BioNTech COVI D-19 Vaccine
with other COVID-19 vaccines to complete the vaccination series. Individuals who have received
one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech
COVID-19 Vaccine to complete the vaccination series.
• Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS
at httP-s://vaers.hhs.gov/reP-ortevent.htmlor (httP-s://vaers.hhs.gov/reP-ortevent.htmlor). by calling
1-800-822-7967. The reports should include the words "Pfizer-BioNTech COVID-19 Vaccine EUA"
in the description section of the report.
• Vaccination providers should review the Fact Sheet for Information to Provide to Vaccine
Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine
Administration Under Emergency Use Authorization.
Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering
Vaccine (Vaccination Providers) including Full EUA Prescribing Information available
at www.cvdvaccine-us.com (httP-:I /www.cvdvaccine-us.com)..
ABOUT PFIZER: BREAKTHROUGHS THAT CHANGE PATIENTS'
LIVES
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At Pfizer, we apply science and our global resources to bring therapies to people that extend and
significantly improve their lives. We strive to set the standard for quality, safety and value in the
discovery, development and manufacture of health care products, including innovative medicines
and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance
wellness, prevention, treatments and cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier innovative biopharmaceutical
companies, we collaborate with health care providers, governments and local communities to
support and expand access to reliable, affordable health care around the world. For more than 170
years, we have worked to make a difference for all who rely on us. We routinely post information
that may be important to investors on our website at www.Pfizer.com (httP-:llwww.Pfizer.com).. In
addition, to learn more, please visit us on www.Pfizer.com (httP-:llwww.Pfizer.com). and follow us on
Twitter at @Pfizer and @Pfizer News, Linkedln, YouTube and like us on Facebook
at Facebook.com/Pfizer.
PFIZER DISCLOSURE NOTICE
The information contained in this release is as of May 7, 2021. Pfizer assumes no obligation to
update forward-looking statements contained in this release as the result of new information or
future events or developments. Hide
This release contains forward-looking information about Pfizer's efforts to combat COVID-19, the
collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA
vaccine program and the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (including qualitative
assessments of available data, potential benefits, expectations for clinical trials, a rolling submission
of a Biologics License Application (BLA) with the FDA for BNT162b2, the anticipated timing of
regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing,
distribution and supply), involving substantial risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such statements. Risks and uncertainties
include, among other things, the uncertainties inherent in research and development, including the
ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical
trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks
associated with preclinical and clinical data (including the Phase 3 data), including the possibility of
unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical
or safety data; the ability to produce comparable clinical or other results, including the rate of
vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of
the Phase 3 trial and additional studies or in larger, more diverse populations upon
commercialization; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants;
the risk that more widespread use of the vaccine will lead to new information about efficacy, safety,
or other developments, including the risk of additional adverse reactions, some of which may be
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serious; the risk that preclinical and clinical trial data are subject to differing interpretations and
assessments, including during the peer review/publication process, in the scientific community
generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA
vaccine program will be published in scientific journal publications and, if so, when and with what
modifications and interpretations; whether regulatory authorities will be satisfied with the design of
and results from these and any future preclinical and clinical studies; whether and when the
submission of the BLA for BNT162b2 in the U.S. will be completed and accepted for review and
whether and when other biologics license and/or emergency use authorization applications or
amendments to any such applications may be filed in particular jurisdictions for BNT162b2 or any
other potential vaccines that may arise from the BNT162 program, and if obtained, whether or
when such emergency use authorization or licenses will expire or terminate; whether and when the
BLA for BNT162b2 in the U.S. and any other applications that may be pending or filed for BNT162b2
(including any requested amendments to the emergency use or conditional marketing
authorizations) or other vaccines that may result from the BNT162 program may be approved by
particular regulatory authorities, which will depend on myriad factors, including making a
determination as to whether the vaccine's benefits outweigh its known risks and determination of
the vaccine's efficacy and, if approved, whether it will be commercially successful; decisions by
regulatory authorities impacting labeling or marketi~cfelanufacturing processes, safety and/or
other matters that could affect the availability or commercial potential of a vaccine, including
development of products or therapies by other companies; disruptions in the relationships between
us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand
for any products may be reduced or no longer exist; risks related to the availability of raw materials
to manufacture a vaccine; challenges related to our vaccine's ultra-low temperature formulation,
two-dose schedule and attendant storage, distribution and administration requirements, including
risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to
successfully develop other vaccine formulations, booster doses or new variant-specific vaccines; the
risk that we may not be able to create or scale up manufacturing capacity on a timely basis or
maintain access to logistics or supply channels commensurate with global demand for our vaccine,
which would negatively impact our ability to supply the estimated numbers of doses of our vaccine
within the projected time periods as previously indicated; whether and when additional supply
agreements will be reached; uncertainties regarding the ability to obtain recommendations from
vaccine advisory or technical committees and other public health authorities and uncertainties
regarding the commercial impact of any such recommendations; challenges related to public
vaccine confidence or awareness; uncertainties regarding the impact of COVI D-19 on Pfizer's
business, operations and financial results; and competitive developments.
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A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K
for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including
in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That
May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed
with the U.S. Securities and Exchange Commission and available at www.sec.gov
(httP-:l/www.sec.gov). and www.P-fizer.com (httP-:/lwww.P-fizer.com)..
ABOUT BIONTECH
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering
novel therapies for cancer and other serious diseases. The Company exploits a wide array of
computational discovery and therapeutic drug platforms for the rapid development of novel
biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and
off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific
checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep
expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its
collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases
alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with
multiple global pharmaceutical collaborators, includµjl~~enmab, Sanofi, Bayer Animal Health,
Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For
more information, please visit www.BioNTech.de (httP-:l/www.BioNTech.de)..
BIONTECH FORWARD-LOOKING STATEMENTS
This press release contains "forward-looking statements" of BioNTech within the meaning of the
Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but
may not be limited to, statements concerning: BioNTech's efforts to combat COVID-19; the
collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine (including a potential
second booster dose of BNT162b2 and/or a potential booster dose of a variation of BNT162b2
having a modified mRNA sequence); the potential of BNT162b2 for adolescents 12 to 15 years of
age, evaluation of BNT162b2 in children 6 months to 11 years old, anticipated timing of regulatory
submissions, regulatory approvals or authorizations, including the Biologics License Application, and
anticipated manufacturing, distribution and supply); our expectations regarding the potential
characteristics of BNT162b2 in our clinical trials and/or in commercial use based on data
observations to date; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus
variants; the expected time point for additional readouts on efficacy data of BNT162b2 in our clinical
trials; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and
market interpretation; the timing for submission of data for, or receipt of, any marketing approval,
including the Biologics License Application, or Emergency Use Authorization; our contemplated
shipping and storage plan, including our estimated product shelf life at various temperatures; the
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risk that demand for any products may be reduced or no longer exist; the ability of BioNTech to
supply the quantities of BNT162 to support clinical development and market demand, including our
production estimates for 2021; and challenges related to public vaccine confidence or awareness.
Any forward-looking statements in this press release are based on BioNTech's current expectations
and beliefs of future events, and are subject to a number of risks and uncertainties that could cause
actual results to differ materially and adversely from those set forth in or implied by such forward
looking statements. These risks and uncertainties include, but are not limited to: the ability to meet
the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability
to produce comparable clinical or other results, including our stated rate of vaccine effectiveness
and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more
diverse populations upon commercialization; the ability to effectively scale our productions
capabilities; and other potential difficulties.
For a discussion of these and other risks and uncertainties, see BioNTech's Annual Report on Form
20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available
on the SEC's website at www.sec.gov (httP-:llwww.sec.gov).. All information in this press release is as
of the date of the release, and BioNTech undertakes no duty to update this information unless
required by law.
CONTACTS
Pfizer Contacts:
Media Relations
Amy Rose
+1 (212)733-7410 Hide
[email protected] (mailto:[email protected]).
Investor Relations
Chuck Triano
+1 (212) 733-3901
[email protected] (mailto:[email protected]).
BioNTech Contacts:
Media Relations
Jasmina Alatovic
+49 (0)6131 9084 1513
[email protected] (mailto:[email protected]).
Investor Relations
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Sylke Maas, Ph.D.
+49 (0)6131 9084 1074
[email protected] (mailto:[email protected]).
P'fizerU> Copyright© 2002-2021 Pfizer Inc. All rights reserved. This information-including product information-is intended
only for residents of the United States.
The products discussed herein may have different labeling in different countries .
Hide
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Exhibit 9
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Home / Advertising / Study Shows "Traditional Linear Review" Almost ...
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A MESSAGE FROM RECOMMIND
Study Shows "Traditional Linear Review" Almost Accounts
for 73% of e-Discovery Costs
FEBRUARY 19, 2013, 4:58 PM CST
Tweet v
Many legal departments are struggling for ways to reduce, or at least stop growth in their legal
budgets. One of the obvious targets for cost reduction in any legal department is the cost of
responding to eDiscovery, including the cost of in-house or external attorney review for
relevance and privilege. Per a Compliance, Governance and Oversight Counsel (CGOC) survey,
the average legal department spends approximately $3 million per discovery to gather and
prepare information for opposing counsel in litigation. The RAND Institute for Civil Justice has
published a 2012 study that points out the cost of legal review for privilege and responsiveness
costs an average of $0. 7 3 for every dollar spent on eDiscovery.
The top four cost reduction strategies legal departments are considering are:
•
1) Bring more evidence collection and analysis in-house to do more Electronically Stored Information
(ESI) processing internally
2) Keep more of the review of ESI in-house rather that utilize outside law firms
3) Explore off-shore review
4) Pressure external law firms for lower rates
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Many law firms are also looking for ways to reduce the cost of document review based on
number 4 above; pressure from their clients to reduce the fees they charge for eDiscovery
review.
The average civil eDiscovery matter can include between 3 and 5 GB of potentially responsive
ESI per employee. To put that in context, 1 GB of data can contain between 10,000 and 75,000
pages of content. Multiply that by 3 and you are conservatively looking at between 30,000 and
50,000 pages of content that should be reviewed for relevancy and privilege per employee. Now
consider that litigation and eDiscovery usually includes more than one employee ... ranging from
two to hundreds.
Traditional linear review, the process used for discovery review for decades, is a manual,
expensive, time-consuming and error-prone process requiring teams of legal professionals to
review hundreds of thousands or millions of documents one page at a time to determine
relevance to a specific case. This review step drives the largest cost of eDiscovery.
In the linear review process, documents are usually split up and given to individual reviewers
haphazardly; the first 200,000 go to Bob, the second 200,000 go to Judy, the third 200,000 go to
Charles in London and so on. Because of this practice and the lack of document prioritization,
potentially critical documents are spread across several reviewers and are not reviewed at the
same time and by the same person, greatly reducing consistency.
Traditional linear review is usually accomplished in the following manner (simplified
process):
1. 1) Data is collected from affected custodians
2) Data is collected from enterprise repositories
3) Keyword searches are run on collected data to build a "potentially responsive data set"
4) The potentially responsive data set of 112 GB (1.12 million documents) is sent to outside counsel for
review and tagging
5) Outside counsel assigns a team(s) of attorneys to review 1.12 million documents for privilege and
relevance
6) At $70/hour and a review rate of 55 documents per hour, total document review costs $1.425 million
In the white paper, Reducing Costs with Advanced Review Strategies -Prioritization for 100%
Review (http:/ /www.recommind.com/ resources/knowledge_library / reducing-costs-advanced-review-strategies-prioritization-100-
review?utm_medium=advert&utm_source=abajoumal-site&utm_campaign=content-prioritization_ wp_abajournal)learn how
organizations are utilizing advanced review strategies to prioritize documents for more
comprehensive Early Case Assessment (ECA) and to save money when performing the review of
an entire document corpus.
Advanced review strategies covered in this white paper include:
App000708Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 79 of 150 PageID 1531Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 79 of 150 PageID 1531
• • A typical linear review process
• Predictive Coding workflows
• Document Prioritization for 100% Review
• The cost savings of Prioritization vs. Linear Review
This content is advertising.
Give us feedback, share a story tip or update, or report an error.
Copyright 2021 American Bar Association. All rights reserved.
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Exhibit 10
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Advanced Analytics Value for Small
Document Review Cases
BLOG June 18, 2020by Aaron Boone, Esq. and Maureen Murchie, CEDS | 5 min read
Can I Use Advanced Analytics For a Small Case?
There is a common misconception that advanced analytics value is derived only on large
document sets and that not all cases are big enough to truly bene t from them. So many
times, I’ve been on calls with outside or in-house counsel and heard the questions: “Will
advanced analytics be useful on such a small set?” or “Is this really enough documents to make
advanced analytics worth it?”
In short, the answer is YES!
I understand and can appreciate the misconception; TAR, in its earlier days, used to require a
good amount of documents in order to feed and seed them. If we’d had this conversation
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three years ago and you didn’t have that initial volume to start, then the answer may well have
been that we couldn’t make much use out of advanced analytics on your small document set.
However, to borrow (clumsily) from Bob Dylan:
The Tools They Are A-Changin’
TAR 1.0 takes a set of documents reviewed by attorneys and then uses those decisions to
make a prediction on the remaining docs—end of story. Since 2017, Brainspace and Relativity
have introduced Active Learning and CMML (Continuous Multimodal Learning), also known as
TAR 2.0 or supervised analytics, which takes the docs we feed and continuously reviews and
continuously scores. Every scoring decision is applied to future documents, so the predictions
get smarter and more accurate as the review moves forward.
Today we have advanced analytics capabilities that extend beyond TAR, and it is these tools
that can result in the biggest savings for your smaller cases. Most advanced analytics tools
come in a bundled deal, meaning that if you use one tool in the platform, you have access to all
of the tools. Email Threading, Near-Duplicate Identi cation, and Textual Duplicate
Identi cation are three of the primary tools you’ve probably already encountered.
Here are some lesser-known advanced analytics tools that can come in handy as well:
•Name Normalization will gather all variations of someone’s email and put their name in a
eld. For example, I have my work email, a google email, a yahoo email, and probably
some others. The analytics would identify all those emails as mine and put my name in a
eld. This is especially helpful for privileged logs.
•Language Identi cation is just that: a tool that identi es the primary and secondary
languages used in your data set. This is great to run at the start of a case to gure out
sta ng needs, like whether you’ll need to hire Spanish, German, or Japanese reviewers for
a foreign language document review.
•PII Identi cation will ag documents for social security account numbers or anything else
that may be con dential so you can redact that information.
Since these tools come in a bundled deal, some clients may think: I only need one tool. If I’m not
going to use all the tools, is it worth having the whole bundle?
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The short answer is YES. But to address this question with another question, let’s return to the
original discussion topic: Does this case have enough documents to use analytics?
Some Easy Math…
Let’s look at a case of 1,000 documents . Let us also assume that this is a sole practitioner, so
only one person is reviewing the documents. I will use some industry averages to show the
advanced analytics value.
1. The average attorney will review 50 documents per hour.
2. The average attorney will charge $200 per hour.
3. The average document reduction from email threading, if looking only at the unique
threads, is 20%.
4. The average increase of review speed, from viewing threads together, is at least 10%.
Let’s say you have a vendor who charges 4 cents per doc for advanced analytics.
Cost of Review Without Email Threading:
•1,000 documents reviewed at 50 documents per hour is 20 hours.
•20 hours at $200 per hour is $4,000.
•Total cost of review: $4,000.
Cost of Review with Email Threading:
•800 documents reviewed at 55 documents per hour is 14.5 hours.
•14.5 hours at $200 per hour is $2,900.
•Cost to run advanced analytics is 1,000 x $.04 which equals $40.
•Cost of a tech to run advanced analytics $200 per hour x 0.5 hours is $100.
•Total cost of review: $3,040.
Total Savings: $960
As you can see, advanced analytics value can have a tremendous impact, regardless of the size
of your case. Keep in mind that the above scenario uses only one of the many tools available
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through the advanced analytics bundle. Our BIA team of lit tech experts working on your
document sets might nd, for instance, that we are able to mass tag a number of near or
textual duplicates together. Using other tools in the bundle could easily increase the average
review rate to 60 documents per hour, saving you or your client another 300 dollars.
Of course, the de nition of “a small case” is di erent for everyone. It could mean one thousand
documents for one client or ten thousand for another. But those smaller cases are where you’ll
start to see the biggest savings and the highest advanced analytics value when you choose a
review company that will use advanced analytics on your document review sets. At BIA, our
tools are top-shelf, and our people have the top levels of training and certi cations needed to
run these tools at their maximum capacity for speed, accuracy, and e ciency.
So the next time you nd yourself wondering if you have enough documents, or if you can
convince your client of the advanced analytics value for your case, I hope you’ll stop wondering
and give BIA a call. Our answer is YES.
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Exhibit 11
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Answering Your Questions about Legal
Document Review
BLOG October 10, 2019 by BIA | 9 min read
Back in 2017, we partnered with Emily Cobb from Ropes & Gray, LLC and the team at ACEDS to
host a webinar covering the ins and outs of successful document review. It was a thoughtful,
helpful discussion on strategies and tips for improving the document review process, and we
covered a lot of ground during the one-hour program, from modern approaches to managed
review, technology-assisted review (TAR), putting together a review team and more.
Attendees posed a lot of great questions and we shared them on the BIA Blog. Since managed
review tools and strategies are always changing for the better, we thought it would bebene cial to refresh and re-share the Q&A to keep the discussion fresh and ongoing. We hope
you nd this information helpful!( )
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1. What is the average rate of legal document review, per
reviewer, on an hourly basis?
It all depends on the complexity of the legal document review protocol, really. Reviews with
simple protocols and easy “yes” or “no” questions will go very quickly, but if your review project
is highly complex, then the review rate will be slower.
For example, the average rate of legal document review for emails only, if you’re only coding
for responsiveness, could be anywhere from 70-80 documents per hour. However, if your
reviewers are sifting through formulas in spreadsheets, you can expect them to spend a lot
more time on each document, not only to review the information but to open the document in
its native software. While some review platforms provide a decent spreadsheet view, the best
way to view all the information in a spreadsheet is still to open it in Excel or Google Sheets.
That means a reviewer may only look at 20-30 documents in an hour.
In general, assuming that reviewers are looking at a mix of documents that include some
spreadsheets, most reviewers average 40-50 documents per hour. 2. When a law rm associate is overseeing an
eDiscovery/managed legal document review project, what is
the role of the project manager at the vendor or corporate
client?
Put simply, the role of the project manager is to work with a law rm associate to keep him or
her informed on the status of each step of the project, including document collection,
processing, search results, review and production. In addition to providing reports and metrics
on the case, the project manager is also there to troubleshoot any issues or facilitate things
like complicated search term requests.
A project manager at the corporate client would be in a similar position. There’s usually a point
person at the corporation who takes the lead in facilitating data collections. During thewebinar, our colleague and fellow presenter Emily Cobb pointed out that it’s the law rm’s neck
on the line in terms of what’s reported out. As such, it’s the law rm associate that has the nal
say on most substantive issues.
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We also did a previous webinar on the role of the eDiscovery project manager , which goes
more in-depth, and can be seen here .
3. Does outside counsel need to do 100% of the quality
control of documents reviewed by contract attorneys or the
managed review vendor?
Generally speaking, no. Of course, that assumes that you have a reasonable level of con dence
in the process, the people and the vendor. Whether done in-house with contract attorneys or
outsourced to a vendor, quality results depend on a quality process from the outset. It helps to
have an ongoing dialogue between the review team and counsel so there is a process to track
questions asked and answered. This promotes consistency and quality in the review product.
Quality control in document review typically involves random samplings throughout the review
process. If the review is being handled by a vendor’s review team or contract attorneys, they
usually have their own QC process, in addition to what outside counsel will do.
We suggest that the samplings happen more often and are more encompassing at the
beginning of the process, looking at the results on an individual reviewer basis to get a sense of
how accurately each person is coding. Also look to see if any problems are widespread, as this
could mean the review protocol was not properly explained or understood.
It’s also good to look at overturn reports, which show when document coding was overturned
by the QC person. If there are patterns there – such as certain types of documents that get
changed often, or if one reviewer’s coding calls are overturned more regularly – you can gain
insight into any potential issues and make adjustments as needed.
With a strong focus on quality, combined with both general and individual feedback addressing
any quality concerns from the outset, you can help ensure that the overall process is a success.
As that proceeds and you become comfortable with your reviewers and the protocols for that
review project, the QC process can be scaled back a bit, but should still include random
samplings of the entire document set throughout the review.
That said, there are certain documents for which we do recommend to have a 100% quality-
check review, whether it’s done by outside counsel or senior level reviewers at your vendor (or
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a combination of both). At BIA, for example, we always make sure there is a second set of eyes
from our team on all documents coded as privileged or “hot.”
4. How has the quality control process matured over time
with the “modern” approach? How can we best leverage
technology to track errors, etc.?
Technology now allows us to more easily locate items that need to be quality controlled. For
example, we utilize TAR technologies not just in review, but also in our QC processes, helping
to quickly highlight any quality concerns. In the past, we would have had to go through the
entire document review process before there were insights to pull. Now, we can quickly andeasily glean valuable insights, such as speci c areas of documents that need to be quality
controlled.
5. What kind of supervision do you give to a rst or second-
year associate managing an eDiscovery/managed legal
document review project?
We do give more training and support to people who are new to the process. We believe it is
BIA’s responsibility to our clients to make sure all associates – and really everyone involved –
fully understand and are comfortable with the proven processes that we have established. We
don’t want anyone to fail.
6. Why do rms not utilize eDiscovery sta attorneys more?
This is an interesting question. Before BIA, I (Barry) worked at a law rm that managed
document review projects with more than 160 contract attorneys on multiple projects. What
we found was that having so many contract attorneys on multiple projects kept us from
building institutional knowledge for a case or client. We changed that process to employ 10-11sta attorneys and recruited out of our existing talent pool of 160+ contract attorneys.
Sta attorneys cost less because they’re not on the partner track at a rm, but they still bill
higher than contract attorneys – so there are two sides at play. But in general, sta
attorneys build cost-e ective institutional knowledge , and they provide consistent coding.
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That’s the same philosophy that we use at BIA with our Managed Document Review
Services team, which provides the bene ts of sta attorneys – including being cost-e ective
and maintaining institutional knowledge – with the ability for our clients to use our attorneys
as needed like one would with a contract attorney review team.
7. Are there any quality issues with the per-doc model’s
incentive to get through legal document review quickly?
No, quite the opposite. With the per-document pricing model, the incentive is directly built into
the model to get it right the rst time around.
BIA’s preferred practice is to bill per document versus per hour, as we nd it’s not only more
predictable for the client, but easier for everyone to manage. We touched on this somewhat
during the webinar, and it is discussed in more depth here .
Simply put, legal document review must be done accurately, or, regardless of how quickly it
was done or how it was billed, it will have to be done again. Our per-doc model of review puts
that burden where it should be – on us. If we don’t maintain the highest quality, thendocuments will need to be re-reviewed, which negatively impacts our pro t on the project.
Thus, inherent in the very model is the incentive for quality from the outset.
BIA’s well-designed process allows for reviewers to take the necessary time to code documents
correctly the rst time and includes both team management and our comprehensive quality
control process all in one simple price. We are convinced of this model’s e ectiveness for
several reasons, but our favorite is that not a single BIA client utilizing this model has ever
looked back.
8. If the other party does not specify format can you produce
in the format you deem reasonable?
Per the federal rules, the answer is yes. However, what one side deems reasonable isn’t
necessarily what the other side will agree upon. It’s good to con rm – more than once – what
the speci ed format will be, just to avoid any back-and-forth in court. It’s not worth the money
or time on either side to argue about the format. We suggest agreeing on an ESI production
protocol at the outset of a matter to minimize ambiguity when completing productions.
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9. How do you measure, monitor and track productivity and
quality?
This is a good sum-up question. At BIA, we look at each individual reviewer’s rate of review
(documents per hour) and then measure speed, accuracy, the di culty of the review material,
amount of errors per set and time spent reviewing. Conducting these measurements gives us a
good indication of how the review is going and points out areas for improvement, be that for
an individual or an entire team.
Want to streamline your document review? Check out our webinar, Document Review: The
EDRM’s Final Frontier , that discusses how to approach, plan for and execute a successful
document review.
Want to learn about using analytics in document review? In our recent Practical Uses of
Brainspace webinar , we discuss how we leverage their technology to deliver unparalleled
accuracy and cost savings to our Managed Document Review o ering.
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Exhibit 12
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Document Review Calculator
How much does an eDiscovery document review cost?
What does managed review cost per document?
How many documents can an attorney review in an hour? In a day?
Electronic discovery costs and document review speed turns on several variables:
The review type (is it a rst pass review for relevance, or are documents coded for legal
issues )?
Is redaction needed? (Does the ESI (electronically stored information) contain personally
identi able information or sensitive information that needs to be kept con dential?)
Is it a linear attorney review with eyes on every document, or a technology assisted review
(TAR --the use of eDiscovery analytics, arti cial intelligence or machine learning)?
What eDiscovery document review software is being used and is there a monthly cost per
gb (gigabyte) for data hosting?
How do these factors impact document review cost?
Speed: The number of coding decisions for each document decreases document review
speed. Simple yes/no, (is it relevant?) rst pass review is generally the fastest type of legal
document review. However, if reviewers must apply issue tags, time spent on each document
increases.
Redaction: Redacting documents also slows document review speed. It takes more time toABOUT SERVICES ARTICLES & RESOURCES CONTACT
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identify and hide sensitive information than it does to make relevance decisions about ESI.
Thus, the average document review speed varies. From 25 documents an hour per reviewer
for heavy redaction to 100 documents per hour (or more) if coding decisions are limited.
Assuming an eight-hour day, the number of documents reviewed per day (by reviewer) is 200on the low end to 800+ on the high end.
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SPONSORED CONTENT , TECHNOLOGY
Privilege Analytics From H5: The Best Way
To Handle Privilege Review
Privilege review and logging no longer has to be a chore you dread.
By Above the Law
December 6, 2021 at 4:40 PM
H5 is now Lighthouse, which strengthens our ability to modernize the eDiscovery and
information governance space with a technology-first focus, meet accelerated demand
for technologies and services that span the entire client data life cycle, and fully embrace
the rapid shifts to cloud and hybrid environments. For more details, visit:..________,JI I.._______,
App000728Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 99 of 150 PageID 1551Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 99 of 150 PageID 1551
https://www.lighthouseglobal.com/news-events/lighthouse-completes-acquisition-of-
h5
Protecting privilege is one of the most critical aspects of any legal matter. Unfortunately, it
can also be one of the most confusing and time-consuming. While eDiscovery has seen
significant advances in recent years, identifying potentially privileged documents,
reviewing them, and ultimately logging them remains an arduous task.
H5 is finally changing all that. H5’s sophisticated Matter Analytics application was built
from the ground up to give you a better eDiscovery experience from within Relativity. The
Privilege Analytics solution within Matter Analytics blends together analytics capabilities
and proprietary, pre-trained linguistics models to help you more easily identify privileged
content, create better workflows for reviewing it, focus in on potential privilege-breaking
scenarios, and seamlessly create privilege logs.
Simply put, privilege review and logging no longer has to be a chore you dread.
How It Works
One of the key things to know about Matter Analytics and Privilege Analytics from H5 is
that these tools exist inside Relativity. They don’t require navigating to outside
applications like some other eDiscovery solutions – all of your data stays within Relativity
and the privilege analysis happens there, making for significantly streamlined workflows
and maximum functionality.
H5 has heavily refined its proprietary algorithms over the years, as well as worked hard to
seamlessly integrate their analytics into Relativity to improve the privilege review
experience, with the help of functions like their proprietary threading and name
normalization (more on that in a bit). Better yet, H5’s staff uses the software itself every
day – so they’re not just blindly developing it, they’re developing it to actually work. And
they’ve succeeded.Privilege Identification
App000729Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 100 of 150 PageID 1552Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 100 of 150 PageID 1552
Privilege Analytics’ core functionalities target the two main facets of privilege –
understanding who the privileged actors are and what legal concepts are at issue (the
“who” and the “what” of privilege).
Identifying privileged documents starts with tackling the “who” through threading and
name normalization. On your main Privilege Analytics screen, you start with an analytics
set of all documents that have been analyzed, broken down into useful graphic cards that
give you a high-level snapshot of exactly what you’re dealing with.
You can click into any card to get more detail about the analysis, including insight into
threading and name normalization.
Threading is an intuitive and powerful way of analyzing and viewing communications in
your potential production. You can think of every thread as a tree with branches. Privilege
Analytics makes it easy to see last-in-time messages, or the ends of the branches where
privilege is often broken.Set Pnv11ege Anafytics Demo (570) -.D
33,015 Documents 2.12 (GB)
Search Nam.: Adrnn \_Al Docs ,_
aem._~
.An.leh"'*"-IS
a0thoir0:lcume na
Lntupdated on 04·13-2021 at 04:03 pm by Hobson. Joel ,. Ea Email Threading (HSET-570)
41.46% Email Reduction
Wlennon-untqllll!parentemailsarerelr04'ed
0
3.35
Averagethreidslze eu!'lique
• Non Unique
To-.,JJ
9,211
Threi3d'1roupcoo rn 10,102
7,154
17.25e ,. @) Name Norma112ation and Entity AnalyslS (H5NN-5
8,134 Entities Identified
•Organi.:.ationProli:es. 0 .,~,·Pn,-
7of7
Name norma!intion fields mmed c.,n
1.-362 ,. ~ Pnv1lege Analytics (HSPA-570)
31.86% Potentially Privileged
Docunents.ldenlmedi15Polencally~
• Po:enni!lly Pm'Jeged
Noc Identified
500
Po:ern.alwaiverofpnvi!ege
0 •
~ Pnvilege Analytics (HSPA-570)
Scope Summary
Analyzed
"""' A.'taehment5
Loor.e~s
lgnored/Excepl!OnS ......
Exceplionr.
aassiflerExcepbClns
TotillDocurnents
Potenlial Waiver of Privilege 32,998
17.255
13,Mt7
2.1..e
33,015 Potentially Privileged Tiers by Family
• iierl-ArtomeyCl;.niconvnu!'li cation
e Tier2-ArtomeyMern:ons
lier3-Generi!llega lTopK:S
Po:ent.allyPrivile.iedNot lderni~e<:I
Total Documen ts
Top 10 Potential 3rd Party Waiver Communicators
PaoulWh:e
C~Wi1:e
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VV..l!er6. ~neo ""''""' -llwdP,rty
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'I
'I , 1
'I 8,000
313
1,244
22.498
33,015 Potentially Privileged Document-level Designations
Designation
Tier 1-A!!orrni!yOientCommlnlC3eon
Tier2-At:omeyMennans
TBM3-Gene<- .al!..g~lop.es
General Firm References
GenerallegalTams
Pl:i1pnvF.-n'Wyl.1en"lb9r
Total Ur,iq,. Documents
Potential Waiver of Privilege Details
e?o:emiaty?rivi leged
e ?o:emialW3iveJofP riYil~
• 3rd P.a,ny Corrmun ica:or
eS<oadD:s~ution
Po:en~aiyf>rivi legedNCllldenmied 0,265
1,785-
1,435-
210 I
1.348-
'·"'
10,517 10.517
22,498
33.015
10.017
500 ...
" 22,408 ,.
App000730Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 101 of 150 PageID 1553Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 101 of 150 PageID 1553
It also performs a full attachment analysis to find all inclusive attachments for every
thread and a full recipient analysis that includes BCCs, which many solutions don’t take
into consideration.
Name normalization is the next step, and it’s aimed at trying to really understand not just
who the people are in your document set, but also what organizations they belong to and
what function they play in the data population. Names can be associated with roles like in-
house or outside counsel, or adversarial organizations and government agencies that
might be privilege-breakers.
App000731Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 102 of 150 PageID 1554Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 102 of 150 PageID 1554
Privilege Analytics allows you to pre-categorize individuals based on their function, and
you can reuse those categorizations from one matter to the next. If you do a lot of work on
behalf of the same client, this feature is a great way to carry your knowledge base over,
ensure consistency, and accelerate your privilege identification in subsequent matters.
Name normalization doesn’t stop at a party’s function. It takes into account all the
different variations in how a person is addressed and the different email addresses they
might use. Domain names are also parsed to better understand the organizations at play
in your document set. Accounting for all these variances is usually a painful slog of
merging profiles and cleaning up details that takes significant time in its own right.
Privilege Analytics makes it easy, and this is yet another useful feature that you can carryforward into other matters.
Running threading and name normalization together is a powerful combination that gets
you to the “who” of your privilege review much more quickly and accurately than other
eDiscovery solutions on the market.
Once you know the “who,” you can focus on the “what.” Privilege Analytics is pre-trained
on over 500 privilege concepts to parse the subject of communications. Using linguistic
modeling, the system can hone in on specific aspects of communications, rather than just
recognizing likely patterns for privileged documents – so if you have two privileged lines
in an email that’s otherwise about holiday plans, the system will still catch it.
The results of the threading and name normalization are then paired with the privilege
concepts to quickly identify and tier levels of privilege in the data population.
Tier one communications are those that involve both identified privileged actors andprivileged legal topics.
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One of the tricky but critical aspects of any privilege review is identifying when an existing
privilege scenario has been broken. Privilege Analytics makes this complicated task much
easier. The system looks not only for privileged actors in email threads, but also for third
parties on otherwise privileged communications. When such a potential privilege-breaker
is identified, the documents are flagged as being potential third-party waivers.
Privilege Review
The tiering feature creates an ideal starting point for your privilege review because it
allows you to get at the most sensitive material right out of the gates.
The H5 Matter Analytics thread viewer takes your privilege review to the next level. Color
coding of thread branches (red for privileged actors, blue for third parties) makes it easy
to see if privilege was broken, and you get to graphically see the branches of how a
communication evolved.
If you see a blue branch, you know your privilege might have been broken. This view is
available right in Relativity, even though it’s a feature you don’t normally get in Relativity
itself. It will also pull in flags from Relativity for things like redactions.
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Privilege Analytics pulls together all parts of a thread into a comprehensive conversation
view of the communication, with every segment in order. You can see exactly when people
joined or left the conversation. In addition to the branch color coding, the privileges
subjects that were identified via the linguistic modeling are highlighted.
Once you finish reviewing a thread and have made your privilege decision, you can
simply advance to the next thread, rather than moving document by document.
Whether you’re engaged in second-pass review or the QC stage, Privilege Analytics is the
easiest way to make informed coding decisions that eliminate some of the most common
mistakes that increase the risk of privilege exposure.
Privilege Logging
Unfortunately, your job’s not done when you finish your privilege review. Creating
privilege logs usually ranks low on the list of any attorney’s favorite tasks. Thankfully,
Privilege Analytics makes that easier, too.
As the system identifies potentially privileged documents, it also assigns auto-reasons for
the privilege identification, which are a great starting point for your privilege log. While
you may need to add more detail or make a few tweaks, the system gives you the building
blocks to log your documents quickly and accurately.
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To create a log, select a saved set of documents and select a template (or create a new one
yourself). Privilege Analytics generates the document list populated with all the requisite
fields, all the individuals identified in every branch of the thread, and the auto-reasons for
privilege.
If you need to see an individual document, you can navigate to it with just a click.
You can edit the log just as you would in Excel to make the final version look exactly the
way you need it to look. Your final output can exist as either an object directly in
Relativity or it can be exported to Excel. You get a beautiful and, more importantly,
accurate privilege log without all the intensive manual labor you’re used to.
Installing Privilege Analytics usually takes less than 15 minutes and H5 has a great
evaluation offer where you can try it for yourself. Chances are, you’ll be sold. If you’re
interested in trying Privilege Analytics with your H5 hosted matter, please contact H5 for
more information”.
With something as important as privilege on the line, you can’t afford to keep doing things
the old way.
TOPICS
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App000736Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 107 of 150 PageID 1559Case 4:21-cv-01058-P Document 32 Filed 12/13/21 Page 107 of 150 PageID 1559
Exhibit 14
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