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IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF TEXAS
____________________________________
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PUBLIC HEALTH AND MEDICAL ) PROFESSIONALS FOR ) TRANSPARENCY, )
)
Plaintiff, )
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v. ) Civil Action No. 4:21-cv-01058-P
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UNITED STATES FOOD AND DRUG ) ADMINISTRATION, )
)
Defendant. )
___________________________________ )
DEFENDANT FOOD AND DRUG ADMINISTRATION’S RESPONSE TO PFIZER
INC’S MOTION FOR LEA VE TO INTERVENE FOR A LIMITED PURPOSE
Pursuant to the Court’s Order of Janua ry 21, 2022, Dkt. No. 43, Defendant Food and
Drug Administration (“FDA”) reports that it consents to Pfizer Inc.’s Motion for Leave to
Intervene for a Limited Purpose (“Pfizer’s Moti on to Intervene” or “Motion”), Dkt. Nos. 40-41,
insofar as Pfizer moves for permissive interventi on under Federal Rule of Civil Procedure 24(b).
As Pfizer noted in its Motion, “it is the Government’s province to make the relevant
determinations under FOIA.” Dkt. No. 40 at 2. However, due to the unp recedented speed with
which the Court has ordered FDA to process th e records at issue, FDA anticipates that
coordination with Pfizer to obtai n the company’s views as to which portions of the records are
subject to Exemption 4, the Trade Secrets Act (“TSA”), 18 U.S.C. § 19 05, or other statutory
protections will be a necessary component of the agency’s endeavors to meet the extraordinary
exigencies of this case. See Defendant’s Motion to Partially M odify Scheduling Order, Dkt. No. Case 4:21-cv-01058-P Document 46 Filed 01/25/22 Page 1 of 4 PageID 2057Case 4:21-cv-01058-P Document 46 Filed 01/25/22 Page 1 of 4 PageID 2057
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37, at 6 (explaining that these efforts are alrea dy underway, and anticipated to evolve). Pfizer’s
participation in this matter will f acilitate these necessary communications.
Additionally, as FDA previously explained, if the agency determines not to withhold
information that might be confidential comm ercial information, it is required under some
circumstances to provide notice to the company that submitted the information. See, e.g., 21
C.F.R. §§ 20.47, 20.48, 20.61(e). The submitter in that circumstance may challenge the disclosure under the Administra tive Procedure Act (a “reverse FOIA” claim), and may assert a
violation of another statute such as the TSA . See Doe, 1 v. Federal Election Comm’n , 920 F.3d
866, 872 (D.C. Cir. 2019) (holding that, because “FOI A is a disclosure statute,” “the agency
cannot possibly violate FOIA” in disclosing information (citing Chrysler v. Brown , 441 U.S. 281,
292 (1979)); see also Northrop Grumman Sys. Corp. v. NASA , 346 F. Supp. 3d 109, 116 (D.D.C.
2018) (holding that in “reverse -FOIA cases” “an aggrieved party may bring an action under the
APA to enjoin an agency from releasing proprie tary information under FOIA in violation of the
Trade Secrets Act” or on the basis that disclo sure is otherwise “unl awful or arbitrary and
capricious ‘agency action.’”). Thus, this case ma y require expedited judi cial resolution of any
“reverse FOIA” issues that may arise. It would fu rther judicial efficiency to resolve in the same
case the FOIA claim and any related “reverse FOIA” claims cognizable under the APA, and
Pfizer’s participation in these proc eedings will further this interest.
Accordingly, FDA shares Pfizer’s view th at, in the unusual and indeed extraordinary
circumstances here presented, Pfizer’s intervention would facilitate an orde rly resolution of this
matter, and consents to Pfizer’s intervention pursuant to Rule 24(b).
Dated: January 25, 2022 Respectfully submitted, Case 4:21-cv-01058-P Document 46 Filed 01/25/22 Page 2 of 4 PageID 2058Case 4:21-cv-01058-P Document 46 Filed 01/25/22 Page 2 of 4 PageID 2058
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B R I A N M . B O Y N T O N Acting Assistant Attorney General C i v i l D i v i s i o n
ELIZABETH J. SHAPIRO
Deputy Director F e d e r a l P r o g r a m s B r a n c h
/s/ Antonia Konkoly
ANTONIA KONKOLY
Trial Attorney United States Department of Justice Civil Division, Federal Programs Branch 1100 L Street, N.W. Room 11110 Washington, D.C. 20005 Tel: (202) 514-2395 Email: [email protected]
Counsel for Defendant Case 4:21-cv-01058-P Document 46 Filed 01/25/22 Page 3 of 4 PageID 2059Case 4:21-cv-01058-P Document 46 Filed 01/25/22 Page 3 of 4 PageID 2059
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CERTIFICATE OF SERVICE
I hereby certify that on January 25, 2022, I el ectronically transmitted the foregoing to the
parties and the clerk of court fo r the United States District Cour t for the Northern District of
Texas using the CM/ECF filing system.
/s/ Antonia Konkoly
ANTONIA KONKOLY
Trial Attorney United States Department of Justice Civil Division, Federal Programs Branch 1100 L Street, N.W. Room 11110 Washington, D.C. 20005 Tel: (202) 514-2395 Email: [email protected]
Case 4:21-cv-01058-P Document 46 Filed 01/25/22 Page 4 of 4 PageID 2060Case 4:21-cv-01058-P Document 46 Filed 01/25/22 Page 4 of 4 PageID 2060