Document text
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
PLAINTIFF ’S MEMORANDUM OF LAW IN OPPOSITION TO DEFENDANT’S
MOTION TO MODIFY THE SCHEDULING ORDER OF THE COURT Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 1 of 20 PageID 1787Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 1 of 20 PageID 1787
ii TABLE OF CONTENTS
INTRODUCTION........................................................................................................................ 1
ARGUMENT ................................................................................................................................ 4
I. The FDA’s Claim That it Cannot Produce 55,000 Pages on March 1st and March
31st is False ......................................................................................................................... 4
II. The FDA’s Delay Tactics Should Not be Countenanced ................................................ 12
III. Holding the FDA to its Representations, Plaintiff Requests the Monthly Rate
Increase to 1 80,000 Pages Per Month .............................................................................. 14
IV. The FDA’s Comments Regarding the Cost of the Review or the Need to Reallocate Resources Cannot Serve to Alter the Court’s Ruling ...................................................... 15
CONCLUSION .......................................................................................................................... 18
Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 2 of 20 PageID 1788Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 2 of 20 PageID 1788
1 INTRODUCTION
It is understandable that the FDA does not want independent scientists to review the
documents it relied upon to license Pfizer’s vaccine given that it is not as effective as the FDA
originally claimed , does not prevent transmission, does not prevent against certain emerging
variants, can cause serious heart inflammation in younger individuals, and has numerous other
undisputed safety issues .1 However, the FDA ’s potential embarrassment over its decision to
license this product must take a back seat to the transparency demanded by FOIA and the urgent
need and interests of the American people to review that licensure data. The Court already
recognized this unprecedented urgent need in its January 6th order directing the FDA to produce
55,000 pages per month.2
The FDA now insists it must delay its first 55,000- page production until May 1, 2022 –
four months after the Court entered its order . However, t he FDA’s own papers seeking this delay
make plain it can produce at a rate of 55,000 pages per month in February and March. The FDA
affirms it has alrea dy “allocated the equivalent of nearly 11 full -time staff to this project” and that
“a review speed of 50 documents per hour was within the normal range for document review in a
complex matter” in private practice ; and here the 50 document per hour rate would be faster since
there is only a need to review for personally identifying information (“ PII”) for most pages .
Hence, i f the FDA’s 11 full- time reviewers work only 7.5 hours per day and review 50 pages (not
1 Reflecting the issues with this product, t he FDA failed to send a representative to a federal court
hearing in this matter on December 14th because of the “FDA’s protocols” regarding COVID -19.
Meaning, despite the FDA’s claim the vaccine is “effective,” the FDA is apparently still scared to
send a representative to the hearing . Its actions speak volumes and cast serious doubt on its words.
2 While the FDA asserts in its motion that Plaintiff “opposes the requested relief and s tated that it
will explain the reasons why in a written response to this Motion ,” Plaintiff clearly set forth within
an email to FDA’s counsel its reasoning for opposing the reduction in the monthly rate and the
FDA chose to not respond and address any concern raised therein. See App000935- App000938. Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 3 of 20 PageID 1789Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 3 of 20 PageID 1789
2 documents) per hour, the FDA could review over 88,000 pages per month in February and March.
That is more than sufficient to produce the 55,000 pages per month currently ordered for these two
months.
Instead of complying with this Court’s reasoned order , the FDA claims these 11 reviewers
can only review a total of 10,000 pages per month. What the FDA does not say, and what basic
math shows, is that a rate of 10,000 pages a month for 11 full-time reviewers amount s to only 5
pages per hour ! This rate is made even more absurd because most of the pages the FDA will be
reviewing during this period are repetitive data files that only requir e second level review to redact
minimal amounts of PII that Pfizer may have left in the documents . FDA’s reality defying claim
and contemptuous approach to its production obligations should not be countenanced. ( Infra § I.)
It is also apparent that the instant demand is just the start of a campaign to delay the
production ordered by the Court. In this first salvo, the FDA is not really asking the Court . It is
instead expressly telling the Court it does not intend to produce more than 10,000 pages per month
for February and March, and de spite claiming it is making “unprecedented” efforts, the FDA
repeatedly tells the Court : “It is not possible to guarantee that FDA will be able to fully comply ”
with the 55,000- page production rate thereafter . (Dkt. No. 38 at APPX004, APPX008.)
Americans must follow the law and the FDA, a multi- billion -dollar agency, should similar ly be
given no safe harbor from complying with the orders of this Court. ( Infra § II.)
The FDA should also be held to what it attests. The FDA, with over 18,000 employees
and an over $3 billion discretionary budget, repeatedly assures the Court that it is taking steps to “marshal every possible resource available to it ,” “acting with maximal urgency to assemble every
possible resource avai lable to it” and “ putting every available resource at its disposal into its efforts
to achieve compliance.” (Dkt. No. 37 at 10, 3, 10.) The FDA also attests that over the coming Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 4 of 20 PageID 1790Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 4 of 20 PageID 1790
3 weeks, it will have 28.5 full -time people reviewing the documents . Working 7.5 hours per day for
20 business days per month, 28.5 people reviewing 50 pages per hour can review a total of
approximately 213,750 pages per month. Putting aside that most of this production can be
reviewed far faster than the rate of 50 pages per hour, Plaintiff asks that the FDA be held to its
representation s and be direct ed to produce at the rate of 180,000 pages per month starting in April.
(Infra § III.)
The Court is, other than Congress, the only check on the FDA. In a free country,
transparency is paramount, and the FDA has chosen to thwart transparency and the requirements
of FOIA by anemically understaffing the office it maintains to respond to FOIA requests . It is
akin to the boy that kills his parents and asks for sympathy for being an orphan. Decrying that this
Court is now making it comply with the law – by actually producing documents in a timely manner
– is ridiculous . It is also incredible for the FDA to claim that compliance here would harm its
health policy objectives. Even if the FDA really does need to spend $4 to $5 million which, as
shown below, is an absurd overestimate, that is an inconsequential amount of its overall $3.41
billion discretionary budget. Moreover, the issues with the Pfizer vaccine – including waning
immunity, variants evading immunity, the failure to prevent transmission, myocarditis, and pericarditis – show that the FDA ’s priority should be to address this product before rushing off to
engage in other activities. ( Infra § IV.)
For these reasons, as explained below, t he Court should refuse to reduce the rate of
production in February and M arch and should increase the rate of production for April and
thereafter to 1 80,000 pages per month consistent with the FDA employing 28.5 full -time reviewers
in the coming weeks to conduct the review and the fact that most of the pages need only be
reviewed for PII. Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 5 of 20 PageID 1791Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 5 of 20 PageID 1791
4 ARGUMENT
I. The FDA’s Claim That it Cannot Produce 55,000 Pages on March 1st and March
31st is False
Plaintiff submitted the instant F OIA request in late August 2021 and filed th is action in
September 2021. (Dkt. No. 1.) Nearly four months later , on January 6, 2022, the Court rejected
the FDA’s patently unreasonable request to produce just 500 pages per month and instead ordered
the FD A to produce 55,000 pages every 30 days starting on March 1, 2022. (Dkt. No. 35.) Now,
the FDA wants to have that deadline pushed to May 1, 2022, which would be nearly four months
after the Court entered its order and nine months after Plaintiff submitted its FOIA request.
However, t he FDA’s excuses for seeking to further delay the production do not withstand even the
most basic scrutiny.
Even more egregious, its excuses are plainly not tethered to the truth. The FDA is clearly
dissembling when it c laims it is taking steps to “marshal every possible resource available to it ,”
that the “FDA is doing everything within its ability to comply with the January 6 Order ,” that it is
“acting with maximal urgency to assemble every possible resource available to it ,” or that the
“FDA is putting every available resource at its disposal into its efforts to achieve compliance with
the Court’s Order.” (Dkt. No. 37 at 10, 2, 3, 10.) It requires suspending reality to accept that the
FDA , with over 18,000 employees and its multi -billion -dollar discretionary budget, could not
comply with the Court’s deadline s if it were truly marshaling every possible resource available to
it. If it was doing so, it could complete the entire production in even less than the originally
requested 108 days .
After making the false claim that it is marshaling every possible resource, which it
apparently defines as assigning “nearly 11 full -time s taff to this project ” (out of its over 18,000
employees), it then makes the outrageous claim to this Court that these nearly 11 full -time staff Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 6 of 20 PageID 1792Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 6 of 20 PageID 1792
5 can only produce 10,000 pages per month in February and March. Some simple math reveals just
how absurd this cl aim is and how it stretches reason to accept that the FDA itself believes this
claim. There are a total of 43 business days during this period, and assuming the 11 reviewers
work 7.5 hours per day, 10,000 pages per month amounts to an average review pace of just 5 pages
per hour !
Bringing the absurdity of the FDA’s position into even sharp er focus is the strai ght-forward
nature of this production. There is no dispute as to the universe of responsive documents . The
FDA has never needed to conduct elaborate search es for documents or engage in a long collection
process . The agency just needs to review the documents already in the Pfizer vaccine’s biologics
license file . The FDA does not need to review those documents for relevance because if a
document is in the file , then it is relevant and responsive.
As for review ing the unquestioned universe of documents, the FDA admits it needs to
review these documents for only two exemptions: trade secrets and PII. That is it.
In its prior briefing, the FDA never contested that almost all the information requested is
clinical trial data that does not contain trade secrets . Making its job even easier , the FDA has now
asked Pfizer to confirm the p ortions of the requested documents that do not contain trade secrets
by February 1, 2022. These non- trade secret documents almost certainly represent the vast
majority of the production. This is obvious from t he fact the FDA claims it will allocate 11 of the
15 contract ors it is hiring to review “those records that do not require review for trade secret or
confidential information .” (Dkt. No. 37 at 3.)
As for the FDA’s need to review for PII , the FDA never contested that Pfizer already
redacted the PII before submitting its documents to the FDA (as it was required to do by FDA
regulations) . See 21 C.F.R. § 20.63(b). The FDA now just wants to do a second review , which is Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 7 of 20 PageID 1793Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 7 of 20 PageID 1793
6 fair enough. However, there is absolutely no reason why a trained reviewer can only review 5
pages per hour if all they are doing is a second level review for PII. Furthermore, for the new
reviewers the FDA is hiring, beyond its 11 current experienced reviewers, training to review for
PII cannot seriously take more than a few hours.
The production the FDA already delivered to Plaintiffs further evidences the absurdity of
the FDA’s claims concerning the complexity of the instant review. The index provided by the
FDA for the Pfizer vaccine biologics file is 87 pages long. (App000939- App1026.) Out of those
87 pages, 68 pages contain just a long list of 1,035 case report form s (“CRF”) files. Each CRF
file contains only data from a clinical trial site. The FDA, based on Plaintiff’s initial sampling
request, produced 37 of the 1,035 listed CRF files. These 37 CR F files contained a total of 8,347
pages. Assuming this sampling is representative, the 1,035 CRF files in the total production will
amount to around 250,000 pages, or more than half of the 450,000 pages that the FDA has indicate d
are responsive to the request at issue.
Taking a closer look at the sample 8,347 pages of CRF files produced to- date, t he only
redaction s the FDA made were for a single type of PII data: date of birth and death. Nothing more.
Moreover, a ll of the 8,347 pages are similar, most of them looking like one of the following two
examples: Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 8 of 20 PageID 1794Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 8 of 20 PageID 1794
7
Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 9 of 20 PageID 1795Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 9 of 20 PageID 1795
8
Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 10 of 20 PageID 1796Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 10 of 20 PageID 1796
9 Claiming it will take a full hour to review 5 pages of the foregoing repetitive documents for only
PII is absurd at best and, at wors t, knowingly deceptive .
Included in Plaintiff’s Appendix are the first 50 pages of each of the three CRF files
produced to date , for a total of 150 combined pages . (App000785- App000934.) According to the
FDA, a review of those pages should take approximately 30 hours. To test this claim, a paralegal
at our firm replaced the redactions from these pages with made- up data . Attorney of record in this
matter, E lizabeth Brehm, carefully reviewed this version of these 150 pages and redacted the
relevant PII in just 14 minutes and 15 seconds . (App000781- App000782.) Ms. Brehm caught all
three of the original redactions – which were birthdates. ( Id.) This test sh ows that the FDA’s time
estimates are patently absurd. It also establishes that the instant request is far from evidence of the
agency “doing everything within its ability to comply with the January 6 Order” as it claims, but
rather is just another exampl e of the agency trying to avoid or delay its FOIA obligations . (Dkt.
No. 37 at 2.)
The Declaration of Douglas Weinfield, Associate Chief Counsel for Discovery within t he
Office of the Chief Counsel of the FDA , makes clear that during his “time in private practice, a
review speed of 50 documents per hour was within the normal range for document review in a
complex matter.” ( Dkt. No. 38 Appx016 ¶ 5) ; see also David Degnan, Accounting for the Costs
of Electronic Discovery, 12 Minn. J.L. Sci. & Tech. 151, 165 (Winter 2011) (“Industry standards
suggest that document reviewers can read, understand, and mark 50 documents per hour.”). As
Mr. Weinfield explains, within these “private practice” reviews , reviewers search for “relevance,
responsiveness, privilege, hot documents, confidentiality , attorney- eyes only designation, and
coding categories .” (Dkt. No. 38 Appx016 ¶ 8). Obviously, just reviewing for PII is far less
burdensome tha n reviewing for all these other categories. H ere, not only is the review only for PII Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 11 of 20 PageID 1797Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 11 of 20 PageID 1797
10 for a majority of the responsive documents but, as shown, most of the documents are also repetitive
clinical trial data documents . Thus, this review is not even a “complex” matter requiring a reduced
review speed of 50 documents per hour, but rather a simple review that can be accomplished at an
even faster rate. Nonetheless, the FDA expects this C ourt to believe that its reviewers can only
review 5 pages per hour .
With just the 11 full time reviewers working 7.5 hours per day and reviewing 50 pages per
hour (rather than the absurd claim of just 5 pages per hour) , the FDA could review over 88,000
pages per month in February and in March 2022. That is more than sufficient to produce the
55,000 pages per month currently ordered by the Court for these two months , and 8 times greater
than the 10,000 per month the FDA requests .
To further confirm these numbers, and the reasonableness of the Court’s existing Order ,
Plaintiff contacted a profess ional document review company, BIA, is a highly regarded and
established document review company that has been performing document review services for law
firms for over 17 years. ( App000782.) Plaintiff provided BIA with copies of the 8,347 pages of
sample CRF data the FDA already produced (after removing redactions and inserting made- up
data) . BIA estimated it could provide project management, and review and redact those documents
for both trade secrets and PII within 50 -70 hours, and for a budget of just $3,700. ( Id.) That is a
rate of between 119 and 166 pages per hour.
The FDA could easily retain BIA (or any similar company) for the entire portion of the
production that only involves PII. In fact, as noted in Plaintiff’s prior papers, BIA estimated it
could complete the whole review of all 450,000 pages for PII and trade secrets within 6 -8 weeks
with 10 reviewers and 1 team lead, for approximately $132,000 (Dkt. No. 31 p. 3), a tiny fraction Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 12 of 20 PageID 1798Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 12 of 20 PageID 1798
11 of the purported $4 to $5 million the FDA claims it will cost to review these documents (Dkt. No.
37 at 9) .
Mr. Weinfield attempts to persuade the Court that the instant FOIA review will be much
harder and more time consuming than a typical private practice review. (Dkt. No. 38 at APPX012-
19.) In this manner he seeks to defend the indefensible : that the FDA’s 11 reviewers can only
review around 5 pages per hour. His arguments are irrelevant and/ or ridiculous:
• Mr. Weinfield never claims that he has specific knowledge of the documents at
issue here. ( Id. at APPX016 ¶ 3 (attesting that the declaration is merely based on
his general “knowledge and expertise in litigation and eDiscovery”).) As a result,
his conclusions are all just generalizations, and lack any specificity whatsoever , and
should therefore be given little if any weight . On the other hand, BIA based its
estimation on a sample of the actual documents at issue here.
• Mr. Weinfield does not even try to claim that PII is in any way complicated to
identify , and since the majority of the records only require review of PII, his
arguments, therefore, have no relevance to the majority of documents at issue. (Dkt. No. 38 at APPX006 ¶ 14 (“By knowing which records the sponsors believe do not contain information protected by FOIA Exemption 4, FDA will be able to … move more quickly through the records if it does not need to search for
Exemption 4 material”).)
• As for the subset of pages that may contain trade secrets and confidential business
information, Mr. Weinfield provides little support for his claim that reviewing for
this information here requires more specific knowledge than is required in a private practice review. Take, for example, an antitrust lawsuit involving a Pfizer drug. In Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 13 of 20 PageID 1799Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 13 of 20 PageID 1799
12 any event, t o the extent that a subset of the responsive documents here could contain
trade secrets or confidential business information, the FDA has already involved
Pfizer to identify such documents , further undermining any claim of burden . (See
Dkt No. 38 APPX007 ¶ 15 (“FDA is actively assessing other potential ways in which it may properly enlist Pfizer -BioNTech to assist with streamlining the
processing of the records at issue in this suit”).) In fact, the FDA has a whole set
of regulations specifically addressing how a company submitting documents to the FDA can and should “designate part or all of the information” that it has submitted to the FDA “as exempt from disclosure under exemption 4 of” FOIA, “either at the time the records are submitted to the Government or within a reasonable time thereafter.” 21 C.F.R. 20.61(d) .
For all these reasons , the FDA’s claim that its current 11 full -time reviewers can only
review 10,000 pages per month for February and March is simply untrue. On the other hand, i f
this claim were true, then it raises to a fever pitch questions regarding the competency of the FDA ,
and it screams the need to get the documents it relied upon to license the Pfizer vaccine into the
hands of independent scientists forthwith .
II. The FDA’s Delay Tactics Should Not be Countenanced All Americans must comply with the law. The FDA again asks this Court for special
dispensation t o avoid what Congress , and this Court, required. Everyday Americans do not get
such reprieve. The law is the law. At the current ordered rate, t he FDA is already being given
leeway with regard to the purpose and intent of FOIA , i.e., timely production. It has been more Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 14 of 20 PageID 1800Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 14 of 20 PageID 1800
13 than four months since Plaintiff commenced this lawsuit and the documents at issue, to be timely
put to good use by independent scientists , are needed forthwith .
That the FDA want s to stall production as long as possible is plain from the fact that during
the parties ’ negotiations and briefing , and during the court hearing, it would not agree to be
obligated to produce more than 500 pages per month. The agency made no secret of this goal ,
even after its counsel was pressed by the Court. And after being ordered to produce at a faster
rate, the FDA has no issue with making plainly ludicrous claims to obtain additional delay.
The FDA also makes clear that this latest maneuver will no doubt be only the first in a
series of delay tactics. In the FDA’s supporting Declaration of Suzann Burk (Dkt. No 38 at
APPX002 -APPX013) , the agency makes clear its future intentions . First, the FDA is not really
asking the Court to produce only 10,000 pages per month for February and March 2022; it is telling
the Court it will not comply with the Court’s order as it exists today. The FDA e xplicitly states it
may not even meet the dramatically reduced page count of 10,000 pages per month, claiming that
even this amount “ cannot be guaranteed,” rather the agency only states that if the productions were
reduced to 10,000 pages for these months , that “would significantly increase the likelihood that
FDA will be able to comply with the Court’s order.” (Dkt. No 38 at APPX012 (emphasis added) .)
Hence, the FDA is saying that it does not intend to comply unless the Court bends to its demand
of 10,000 pages for the next two productions and, even then , it may not comply with that amount.
Incredibly, the FDA then goes on to say that it may not comply with the 55,000 pages per
month obligation thereafter. Indeed, after claiming the agency will assign 28.5 full time reviewers
to the project ,3 the Declaration of Suzann Burk say s that:
3 The FDA is attested to the Court that it plans to hire 15 contractors (Dkt. No. 38 at APPX009 ¶
22), “detail” 8 agency employees (Id. at APPX005 ¶ 8) , and assign 5.5 of its normal review staff
to the project (Id. at ¶ 10) , for a total of 28.5 reviewers . Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 15 of 20 PageID 1801Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 15 of 20 PageID 1801
14 Even once the new hires fully take effect, meet ing the production
burden of 55,000 pages per month will pose a challenge to the
agency. As discussed above, FDA is making every effort to comply with this Court’s order in good faith. But in months where the agency is processing especially challenging r ecords or may be
dealing with staff reductions due to illness, attrition, or other reasons
beyond FDA’s control, the enormity of a 55,000 page per month obligation could still prove too much.
(Dkt. No 38 at APPX008.) In establishing the 55,000 pages per month rate, the Court already took
into account “ the FDA’s concerns regarding the burdens of production” and balanced those against
the “need for unprecedented urgency.” (Dkt. No. 35 at 3.) As such , the agency cannot simply tell
the Court that because of the burden on it , the agency may choose to not comply.
That t he FDA does not intent to comply with the Order is further foreshadowed by its
harping on its claimed “good faith.” It is plainly layin g the foundation for not being held in
contempt when it later fails to comply with the Order. Judging the FDA by its actions, not its
words, it is clear why the FDA filed this motion : it is setting up for delay and more delay later with
the cover of supposed good faith attempts at compliance, none of which is actually made in good
faith. Thus, s hould the Court grant the agency its requested inch (a 90,000- page reduction for
February and March) in this motion , it has made clear it will subsequently take ma ny miles.
If the FDA is willing to dissembl e in this motion by claiming that its current 11 employees
assigned to the project can only review on average 5 pages per hour , then there is no reason to
think anything it says regarding its intentions are true.
III. Holding the FDA to its Representations, Plaintiff Requests the Monthly Rate
Increase to 180,000 Pages Per Month
Since the FDA has affirmed to this Court that it is taking steps to “marshal every possible
resource available to it ,” is “acting with maximal urgency to assemble every possible resource Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 16 of 20 PageID 1802Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 16 of 20 PageID 1802
15 available to it” and “ is putting every available resource at its disposal into its efforts to achieve
compliance,” the Plaintiff asks that the Court hold the FDA to its representations .
The FDA asserts that over the coming weeks, it will have 28.5 full -time people to conduct
a review of the documents. Working 7.5 hours per day for 20 business days in a month, 28.5
people reviewing 50 pages per hour can review a total of approximately 213,750 pages per month.
Reducing this monthly rate by another 15% to allow for different types of documents, and
potential delays caused by unforeseen issues – such as “ staff reductions due to illness, attrition, or
other reasons ” referenced by Ms. Burk (Dkt. No 38 at APPX008) – results in a n exceedingly
reasonable rate of 1 80,000 pages per month. Meaning, putting aside that a document review
company could review these documents within weeks with far less people and for a tiny fraction
of the budget claimed by the FDA, and that most of the documents (which only involve PII) can
be reviewed far quicker than 50 pages per hour, with 28.5 full time reviewers the agency should
be able to easily review 1 80,000 pages per month.
As for the FDA’s claim that the rate in this case is unprecedented, the FDA, as noted in
prior argument, fails to identify the relevant metric . The rate is the tail, and the dog is FOIA’s
requirement that the documents be timely produced. Here, the minimum rate of 55,000 pages per month still means the documents will not be produced until at least the end of September which,
given the current issues with the pandemic , is respectfully still not timely for the current needs.
Independent scientists need these document s today.
IV. The FDA’s Comments Regarding the Cost of the Review or the Need to Reallocate
Resources Cannot Serve to Alter the Court’s Ruling
The FDA repeatedly makes hyperbolic comments in its papers about the cost of the review
and the resources it needs to transfer to comply with the Court’s order. However, the FDA never Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 17 of 20 PageID 1803Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 17 of 20 PageID 1803
16 makes explicit its reasons for making these comments , and it appears th e FDA is merely trying to
make the Court feel guilty for ordering the production in the first place .4
The Court is, other than Congress, the only check on the FDA. In a free country,
transparency is paramount, and the FDA has chosen to thwart transparency and the requirements
of FOIA by anemically understaffing the office it maintains to respond to FOIA requests . The
FDA’s understaffing of its FOIA office is in itself a violation of the obligation of FOIA. Decrying
that this Court is now making it comply with the law – by making the agency actually produc e
documents in a timely manner – is incredible . Trying to m ake the Court feel it is doing something
wrong by making the FDA comply with the law is the height of absurdity. That the FDA is not
sufficiently staffed to timely respond to all the transparency requests from the American people is
not the fault of the Court but rather falls squarely upon the FDA itself for understaffing the
personnel available to respond to these requests .
The FDA additionally wants to en sure that the Court’s effort to mak e it come close to
complying with the law is a one -time affair for this case and this case only. By the way the FDA
describes its supposedly “unprecedented’ actions to comply, the agency makes it sound like it is
attempting to land a man on the moon, rather than simply produce documents it has in its
possessio n and is statutorily obligated to produce. It is shameful for the agency to continue to
4 The FDA also attempts to minimize the unprecedented importance that the Court already found
regarding the instant FOIA production. In her declaration, Ms. Burk reiterates the FDA’s earlier
claims that the agency supposedly published information that “provides the public with substantial
information that it can use to evaluate FDA’s determination approving the” Pfizer vaccine. (Dkt. No. 38 APPX003 ¶ 2.) When it directed that the FDA produce 55,000 pages per month, the Court
already dismissed this claim and concluded that the public requires the underlying data so that independent scientists can review the FDA’s claims, and not just items created by FDA that were
sanitized for public review. Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 18 of 20 PageID 1804Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 18 of 20 PageID 1804
17 conduct itself in this manner instead of simply do ing what it is required to do by statute and now
by Court order: timely respond to all FOIA requests .
It is also re markable for the FDA to claim, with its over $3.41 billion discretionary budget,
that compliance here would harm its health policy objective s. Even if the FDA really does need
to spend $4 to $5 million, which as shown above is an absurd overestimate , that is an
inconsequential amount of its overall discretionary budget . Moreover, the issues with the Pfizer
vaccine – including waning immunity, variants evading immunity, the failure to prevent
transmission, myocarditis, and pericarditis – show that the FDA ’s priority should be to address
this product before rushing off to engage in other activities.
Instead, the FDA gripes about the fact that it must now purportedly spend $4 to $5 million
from its discretionary budget of over $3.41 billion and allocate a few employees when it has over
18,000 of them. The FDA claims the COVID -19 vaccine is the most important thing it is doing to
fight C OVID -19, yet now when it needs to be transparent with the American public it tries to claim
that every sin gle other expense it has is more important .
Among the list of its complaints, the agency grip es that it need s to review new product
applications and responding to this FOIA at the Court -ordered rate o f production adversely affects
that. P utting aside that the resources for the instant document review are not material to its 18,000
employees and over $3.41 billion discretionary budget, it fails to advise the C ourt that
pharma ceutical companies pay user fees directly to the FDA in order to carry out these new product
application reviews – the user fees are not part of the discretionary budge t and amounted to $2.8
billion last year and are expected to exceed that amount this year.5
5 See https://www.fda.gov/about -fda/budgets/2021- budget -summary . Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 19 of 20 PageID 1805Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 19 of 20 PageID 1805
18 If a multi- billion -dollar company’s counsel advised the C ourt that it could not comply with
a document demand within even 60 or 90 days for lack of resources, the company would find no
safe harbor before almost any federal judge. The FDA shouldn’t either.
CONCLUSION
Plaintiff respectfully asks that the FDA’s r equest to reduce the monthly rate for February
and March be denied and that, irrespective of whether that request is granted or denied, that the FDA be ordered to produce 180,000 pages on April 30, 2022 and every 30 days thereafter.
Dated: January 24, 2022
SIRI & GLIMSTAD LLP
/s/ Aaron Siri
Aaron Siri , NY Bar No. 4321790
Elizabeth A. Brehm, NY Bar No. 4660353
Gabrielle G. Palmer, CO Bar No. 48948
200 Park Avenue
17th Floor
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
Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 20 of 20 PageID 1806Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 20 of 20 PageID 1806