FDA Response to Pfizer Motion to Intervene — PHMPT v. FDA

Record facts

UNITED STATES DISTRICT COURT · No. 4:21-cv-01058-P · Doc. 46 · 2022-01-24 · Docket on CourtListener

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IN THE UNITED STATES DISTRICT COURT 
FOR THE NORTHERN DISTRICT OF TEXAS 
____________________________________ 
 
 
 
 
 
 
) 
PUBLIC HEALTH AND MEDICAL  
) 
PROFESSIONALS FOR 
 
 
) 
TRANSPARENCY,  
 
  
) 
) 
Plaintiff, 
 
) 
) 
v. 
 
 
 
)  
Civil Action No. 4:21-cv-01058-P 
) 
UNITED STATES FOOD AND DRUG 
) 
ADMINISTRATION, 
 
 
) 
) 
Defendant. 
 
) 
___________________________________  ) 
 
 
 
DEFENDANT FOOD AND DRUG ADMINISTRATION’S RESPONSE TO PFIZER 
INC’S MOTION FOR LEAVE TO INTERVENE FOR A LIMITED PURPOSE 
 
Pursuant to the Court’s Order of January 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 Motion to Intervene” or “Motion”), Dkt. Nos. 40-41, 
insofar as Pfizer moves for permissive intervention 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 unprecedented speed with 
which the Court has ordered FDA to process the records at issue, FDA anticipates that 
coordination with Pfizer to obtain 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. § 1905, 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 Modify Scheduling Order, Dkt. No. 
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37, at 6 (explaining that these efforts are already underway, and anticipated to evolve). Pfizer’s 
participation in this matter will facilitate these necessary communications. 
Additionally, as FDA previously explained, if the agency determines not to withhold 
information that might be confidential commercial 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 Administrative 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 “FOIA 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 proprietary information under FOIA in violation of the 
Trade Secrets Act” or on the basis that disclosure is otherwise “unlawful or arbitrary and 
capricious ‘agency action.’”). Thus, this case may require expedited judicial resolution of any 
“reverse FOIA” issues that may arise. It would further 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 proceedings will further this interest. 
Accordingly, FDA shares Pfizer’s view that, in the unusual and indeed extraordinary 
circumstances here presented, Pfizer’s intervention would facilitate an orderly resolution of this 
matter, and consents to Pfizer’s intervention pursuant to Rule 24(b). 
 
Dated: January 25, 2022 
 
 
Respectfully submitted, 
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BRIAN M. BOYNTON 
 
 
 
 
 
 
Acting Assistant Attorney General 
 
 
 
 
 
 
Civil Division 
 
 
 
 
 
  
 
 
 
 
ELIZABETH J. SHAPIRO  
 
 
 
 
 
 
Deputy Director  
 
 
 
 
 
 
Federal Programs Branch 
 
 
  
 
 
 
 
 
 
/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: antonia.konkoly@usdoj.gov 
 
Counsel for Defendant 
 
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CERTIFICATE OF SERVICE 
 
 
I hereby certify that on January 25, 2022, I electronically transmitted the foregoing to the 
parties and the clerk of court for the United States District Court 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: antonia.konkoly@usdoj.gov 
 
 
 
 
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