First Joint Report — PHMPT v. FDA

Record facts

U.S. District Court for the Northern District of Texas · No. 4:21-cv-01058-P · Doc. 18 · 2021-11-05 · Docket on CourtListener

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IN THE 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 
 
 
 
JOINT REPORT  
 
Plaintiff, Public Health and Medical Professionals for Transparency (“PHMPT”), by and 
through its attorneys, and Defendant, the U.S. Food and Drug Administration (the “FDA”), by and 
through its attorney, hereby submit this Joint Report in compliance with the Court’s Order of 
October 18, 2021, ECF No. 16.  The parties provide the following in response to the Court’s 
inquiries: 
1. 
Meeting of Counsel and Progress Toward Settlement: On November 3, 2021, lead 
counsel for PHMPT, Aaron Siri, and lead counsel for FDA, Courtney Enlow, met in Arlington, 
Virginia.  Although no settlement was reached, the parties continued to negotiate in good faith a 
production schedule for the non-exempt portions of records responsive to PHMPT’s Freedom of 
Information Act (“FOIA”) request.   
2. 
Summary of Claims and Defenses:  
a. PHMPT brought this action under the FOIA, 5 U.S.C. § 552, and 21 C.F.R. 
§ 601.51(e), seeking from FDA: “All data and information for the Pfizer 
Vaccine enumerated in 21 C.F.R. § 601.51(e) with the exception of publicly 
available reports on the Vaccine Adverse Events Reporting System.” 
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b. FDA raised two defenses in its answer: (1) Some or all of the requested 
records or information may be exempt from disclosure, in whole or in part, 
under 5 U.S.C. § 552(b); and (2) Plaintiff’s FOIA request is improper to the 
extent it does not reasonably describe the records requested, as required by 
5 U.S.C. § 552(a)(3)(A). 
3. 
Proposed Time Limit to Amend Pleadings and Join Parties:  Plaintiff reserves the 
right to amend the pleadings and join parties as provided in the FRCP and Defendant’s position is 
that no amendment of pleadings or joinder of parties is necessary in this FOIA action. 
4. 
Proposed Time Limit to File Various Types of Motions, Including Dispositive 
Motions:  The Plaintiff’s position is that the FDA should make “immediately available” all 
documents underlying the licensure of Pfizer’s Covid-19 vaccine, as required by 21 C.F.R. 
§ 601.51(e).  Plaintiff therefore intends to file a motion for summary judgment seeking to compel 
the production of these documents as required by 21 C.F.R. § 601.51(e).   
Defendant’s Position: FDA respectfully submits that it is premature to set deadlines for 
dispositive motions, as such briefing in a FOIA case is appropriate not to compel production, as 
Plaintiff implies, but rather to litigate the adequacy of the search or the propriety of redacted 
information under FOIA exemptions.1  Defendant respectfully requests that the Court not set a 
 
1 Continuation of Defendant’s Position: Contrary to Plaintiff’s suggestion, FDA’s regulations do not require or suggest 
that FDA will release all publicly releasable data immediately after a biologics license application is approved.  When 
read in context, it is clear that FDA’s regulations establish when information in a biological product file is held in 
strict confidence by the agency and when certain data can be released to the public, for instance in response to standard 
processing of a request submitted under the Freedom of Information Act.  See generally 21 C.F.R. 601.51.  Put another 
way, the regulations establish the point in time when records that may previously have been unavailable for public 
disclosure lose their status as confidential and thus become available for public release “immediately” upon occurrence 
of the triggering event.  Specifically, under 21 C.F.R. 601.51, the existence of a biological product file will not be 
disclosed by FDA prior to BLA approval unless it has been previously disclosed or acknowledged, and no data or 
information in that file is available for public disclosure.  21 C.F.R. 601.51(b, c).  If the existence of the biological 
product file has been acknowledged before a license has been issued, FDA generally still will not make information 
and data in the file available for public disclosure prior to issuance of a BLA license.  21 C.F.R. 601.51(d).  Once a 
license has been issued, however, certain data and information in the biological product file become “immediately” 
available for public disclosure.  21 C.F.R. 601.51(e).  That means that if a properly submitted FOIA request is received 
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deadline for dispositive motions at this stage in the litigation and instead set a processing schedule.  
Once FDA has completed its production of records responsive to Plaintiff’s FOIA request, 
Defendant proposes that the parties file a joint status report wherein they propose a schedule for 
summary judgment briefing. 
5. 
Proposed Time Limit for Designation of Experts: At this time, the parties agree that 
designations of experts will likely be unnecessary in this FOIA action.  Indeed, the U.S. District 
Court for the District of Columbia—which handles “[a] significant portion of the nation’s FOIA 
actions”—explains in a comment to their Local Rule 16.3(b) that actions under FOIA are actions 
that “typically do not require discovery or actions in which an initial disclosure requirement would 
not make sense.” 
6. 
Proposed Time Limit for Objection to Experts:  The parties agree that objections to 
experts are likely unnecessary for the reason set forth in paragraph 5. 
7. 
Proposed Plan and Schedule for Discovery:  The parties agree that a proposed plan 
and a schedule for discovery are not necessary at this stage in the proceedings for the reasons set 
forth in paragraph 5. 
8. 
Statement on Limitations for Discovery:  The parties agree that such limitations are 
not necessary at this stage of the proceedings for the reasons set forth in paragraph 5. 
9. 
Statement on the Method for Disclosing and Conducting Discovery:  The parties 
agree that such a statement is not necessary at this stage in the proceedings for the reasons set forth 
in paragraph 5. 
 
for data and information listed in 21 C.F.R. 601.51(e), FDA may publicly release such information in response to such 
request, without need for additional agency action to reclassify as publicly releasable data and information that had 
previously been deemed confidential.  Many BLAs, including the one at issue in this case, contain hundreds of 
thousands of pages.  It is not feasible for FDA to review and produce such large volumes of data immediately upon 
the approval of each BLA, and FDA does not interpret its regulations to require such. 
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10. 
Proposals Regarding the Handling and Protection of Privileged or Trial Preparation 
Material:  The parties agree that such a proposal is unnecessary for the reasons set forth in 
paragraph 5. 
11. 
Proposed Trial Date:  The parties agree that a proposed trial date is unnecessary at 
this stage in the litigation because “[m]ost FOIA cases are resolved by the district court on 
summary judgment, with the district court entering judgment as a matter of law.”  Animal Legal 
Def. Fund v. U.S. Food & Drug Admin., 836 F.3d 987, 989 (9th Cir. 2016). 
12. 
Proposed Mediation Deadline: The parties agree that mediation is not necessary in 
this FOIA action. 
13. 
Statement on Initial Disclosures:  The parties agree that initial disclosures are not 
necessary in this FOIA action for the reasons set forth in paragraph 5 and request that the Court 
waive the initial disclosures requirement.  See U.S. District Court for the District of Columbia, 
Local Rule 16.3(b) comment, 40 (describing FOIA cases as “actions that typically do not require 
discovery or actions in which an initial disclosure requirement would not make sense”), 
https://www.dcd.uscourts.gov/sites/dcd/files/local_rules/Local%20Rules%20Sept_2021_0.pdf. 
14. 
Statement of Whether Parties Will Consent to a Trial Before a Magistrate Judge:  
The parties do not consent to a trial before a magistrate judge. 
15. 
Whether a Conference with the Court is Desired:  
Plaintiff’s Position: Plaintiff respectfully requests a conference with the Court as soon as 
practicable.  The Plaintiff – comprised of highly accomplished scientists from prestigious 
universities from across the country –  seeks a copy of the data provided by Pfizer to the FDA for 
the licensure of its COVID-19 vaccine (the “Pfizer Vaccine” or “Comirnaty”).  The FDA 
received and reviewed this data and licensed Pfizer’s vaccine in under four months.  Pursuant to 
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FDA’s own regulation, this data is to be made “immediately available for public disclosure.” 21 
C.F.R. § 601.51(e).  Nonetheless, despite the passage of two and half months since licensure, the 
FDA has not made a single page of Pfizer’s submission public.  The FDA position appears to be 
that while it was able to review the over 300,000 pages provided by Pfizer, including extensive 
and complex statistical analysis and review, in less than four months, it can only review for public 
production a few hundred pages this month.  The FDA provided Plaintiff with a PDF copy of the 
index of the documents provided by Pfizer (copy attached) and in an attempt to compromise, the 
Plaintiff asked if the FDA would produce the following by the end of this month: 
1. PDF page 27:  CRFs for site 1055  
2. PDF page 31:  CRFs for site 1081 
3. 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  
 
The FDA rejected this proposal and only offered to provide item 6 on this list and one of the SAS 
files.  At that rate of production, it would take over 80 years to produce the data Pfizer submitted 
to the FDA to license its COVID-19 vaccine.   
The FDA’s position is also incredible given that the federal government is mandating that 
millions of Americans receive Pfizer’s vaccine under penalty of being fired from their jobs while 
at the same time giving immunity to Pfizer for any injuries from this product.  This unique situation 
demands the FDA (as its own regulations reflect) immediately make the data underlying the 
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licensure of this product public, including to the dozens of independent scientists on whose behalf 
this request was submitted.  Plaintiff therefore seeks an immediate conference with the Court to 
address the FDA’s refusal to timely produce the data underlying the licensure of Pfizer’s COVID-
19 vaccine.2 
Defendant’s Position: Defendant respectfully requests a conference with the Court to set a 
schedule for the processing of records responsive to Plaintiff’s FOIA request. 
FDA is committed to transparency, in general, and in particular with respect to records 
related to the Biological License Application (“BLA”) for the Comirnaty vaccine.3 
Plaintiff’s FOIA request effectively seeks all publicly releasable information from the 
Comirnaty BLA.  FDA has conducted an initial assessment of the number of records responsive 
to Plaintiff’s FOIA request and has determined that more than 329,000 pages of documentary 
records, plus other files, typically containing data in a format similar to a spreadsheet that are not 
captured in this page count, such as SAS data files, are responsive to Plaintiff’s FOIA request.  
Some of those spreadsheets themselves are extremely large, containing dozens of columns and 
more than ten thousand rows of data.   
In processing records responsive to FOIA requests, FDA must conduct a careful review of 
records before they are released, often on a line-by-line basis. This review is entirely different from 
the review conducted by FDA’s scientists when reviewing a BLA.  The review that must be 
conducted in this case, which is conducted by government information specialists, is necessary to 
ensure that no information exempt from the FOIA is released.  Plaintiff has requested records that 
 
2 The FDA claims it has released a significant amount of information on its website, but those documents are all the 
FDA’s own analysis.  Not the data provided by Pfizer to the FDA for licensure of Comirnaty. 
3 Indeed, FDA released a significant amount of information related to the Comirnaty approval on its website shortly 
after the BLA was approved.  That information includes, among other things, the package insert, the approval letter, 
a summary of FDA’s basis for action, and over a dozen FDA review memoranda.  U.S. Food and Drug Admin., 
“Cominarty,” https://www.fda.gov/vaccines-blood-biologics/comirnaty (last accessed: Nov. 4, 2021). 
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comprise information submitted by the vaccine sponsor (Pfizer-BioNTech).  From FDA’s 
experience with other FOIA requests, such records can be expected to contain both confidential 
business and trade secret information of Pfizer or BioNTech and personal privacy information of 
individuals who participated in clinical trials.  This type of information is exempt from production 
under the FOIA.  See 5 U.S.C. § 552(b)(4), (b)(6).  To ensure protection of this information, and 
other information subject to withholding under the FOIA exemptions, FDA must carefully review 
and, if necessary, redact exempt information on a line-by-line basis.  Due to the vast size of 
Plaintiff’s request, FDA’s limited resources for processing FOIA requests, and currently 
extraordinary demand for FDA records,4 it is not feasible for FDA to review and produce the 
substantial volume of records that Plaintiff seeks to obtain on a short timeframe. 
FDA has worked with Plaintiff in an attempt to develop a production schedule that would 
prioritize production of the portion of the biological product file of most interest to Plaintiff.  
Plaintiff has provided a priority list to FDA, but Plaintiff’s most recent proposal would require 
FDA to review and process over 20,000 pages in less than a month.   
FDA is committed to processing Plaintiff's FOIA request as soon as practicable and has 
taken affirmative steps to do so.  FDA proposes to process and produce the non-exempt portions 
of the following records by the following dates: 
• November 17:  
o From Section 5.2 of the BLA file: 
 
4 Because of FDA’s size and the large number of records generated during the course of agency business, and the 
different components within FDA, the agency’s FOIA program is decentralized.  Plaintiff’s FOIA request is being 
processed by the Access Litigation and Freedom of Information Branch (the “Branch”) in FDA’s Center for Biologics 
Evaluation and Research (“CBER”).  The Branch has a total of ten employees, including the director and two trainees.  
It is currently responsible for processing a total of approximately 400 currently pending FOIA requests, including 
Plaintiff’s. CBER is currently involved in 6 active FOIA litigation matters.   
 
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 The Tabular Listing 
 The Listing of Clinical Sites 
o The Reports of Postmarketing Experience from Section 5.3.6 of the BLA 
file 
o One SAS file.5   
• December 1: remainder of section 5.2 of the BLA file. 
After the December 1 production, FDA proposes to work through Plaintiff’s priority list in order 
of priority and process and release the non-exempt portions of those records to Plaintiff on a rolling 
basis.  
This proposal is a reasonable processing schedule that takes into account FDA’s obligations to 
respond to other document requests, meet its stipulated document processing deadlines in other 
matters, and thus, fairly respond to other FOIA requestors, including the many with requests that 
were received ahead of Plaintiff’s.  Moreover, this proposed processing schedule is consistent with 
those entered by courts around the country.6 
 
5 Plaintiff has requested to receive the SAS files in their native format.  FDA customarily converts SAS files to PDF 
files because PDFs can be redacted to prevent the release of non-exempt information.  However, FDA is willing to 
produce SAS files to Plaintiff (if it is feasible for FDA to do so) with the parties’ understanding that FDA may have 
to delete, rather than redact, exempt information from those files to prevent disclosure of exempted information.   
6 See, e.g., Documented NY v. U.S. Dep’t of State, No. 20 Civ. 1946 (AJN) (S.D.N.Y.) Dkt. 26 p.2 (denying plaintiff’s 
processing rate demand of 2,500 pages per month and adopting Department of State’s proposed 300 pages per month); 
NYCLU v. Admin. for Children & Families, No. 20 Civ. 183 (MKV), Dkt. No. 30 (S.D.N.Y. May 5, 2020) (400 pages 
per month); Color of Change v. U.S. Dep’t of Homeland Sec., 325 F. Supp. 3d 447, 451 (S.D.N.Y. 2018) (500 pages 
per month); Davis v. U.S. Dep’t of Homeland Sec., No. 11-cv-203 (ARR) (VMS), 2013 WL 3288418, at *1 (E.D.N.Y. 
June 27, 2013) (500 pages per month); Blakeney v. FBI, No. 17-cv-2288 (BAH), 2019 WL 450678, at *2 (D.D.C. Feb. 
5, 2019) (500 pages per month); Colbert v. FBI, No. 16 Civ. 1790 (DLF), 2018 WL 6299966, at *3 (D.D.C. Sept. 3, 
2018) (500 pages per month); Middle E. Forum v. U.S. Dep’t of Homeland Sec., No. 17 Civ. 767 (RCL) (GMH), 2018 
WL 1178022, at *3–4 (D.D.C. Mar. 5, 2018) (500 pages per month); id. at *3 n.3 (noting that, “[i]n a number of recent 
cases in this District, a production rate of 500 pages per month has been approved,” and collecting cases); Republican 
Nat’l Comm. v. U.S. Dep’t of State, No. 16 Civ. 486 (JEB), 2016 WL 9244625, at *1 (D.D.C. Sept. 16, 2016) (500 
pages per month); Energy & Env’t Legal Inst. v. U.S. Dep’t of State, No. 17 Civ. 340 (D.D.C.), Minute Order of 
August 22, 2017 (300 pages per month); Judicial Watch, Inc. v. U.S. Dep’t of State, No. 17 Civ. 205 (D.D.C.), Minute 
Order of June 30, 2017 (300 pages every four weeks); Am. Ctr. for Law & Justice v. U.S. Dep’t of State, No. 16 Civ. 
2516 (D.D.C.), Minute Order of June 27, 2017 (process 400 pages per month); Citizens United v. U.S. Dep’t of State, 
No. 16 Civ. 67 (D.D.C.), Dkt. 17 at 3 (declining “to adopt Plaintiff’s proposed production order of 2000 pages per 
month” and instead holding State “to its 300-page commitment”); Freedom Watch v. Bureau of Land Mgmt., No. 16 
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16. 
Other Information and Proposals:  FDA has conducted an initial assessment of the 
volume of records responsive to PHMPT’s request and has determined that there are at least 
329,000 pages responsive to PHMPT’s request.  The parties have conferred in good faith on several 
occasions in October and November 2021 to develop a proposed schedule for FDA to process and 
produce the non-exempt portions of records responsive to PHMPT’s request to PHMPT.  The 
parties failed to reach agreement.   
 
Dated:  November 5, 2021 
 
 
 
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 
aaron@sirillp.com 
ebrehm@sirillp.com 
gpalmer@sirillp.com 
 
 
HOWIE LAW, PC 
/s/ John Howie 
John Howie 
Texas Bar Number: 24027239  
2608 Hibernia Street 
Dallas, Texas 75204 
Tel: (214) 622-6340 
jhowie@howielaw.net 
 
Attorneys for Plaintiff 
  
 
 
 
 
Civ. 2320 (D.D.C.), Minute Order of June 13, 2017 (500 pages every 30 days); Citizens United v. U.S. Dep’t of State, 
No. 15 Civ. 1720 (D.D.C.), Dkt. 11 ¶ 10 (500 pages every four weeks); Judicial Watch, Inc. v. U.S. Dep’t of State, 
No. 15 Civ. 687 (D.D.C.), Minute Order of April 4, 2017 (500 pages per month). 
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BRIAN M. BOYNTON  
Acting Assistant Attorney General  
Civil Division  
 
ELIZABETH J. SHAPIRO  
Deputy Director  
Federal Programs Branch  
 
/s/Courtney D. Enlow 
COURTNEY D. ENLOW  
Trial Attorney  
United States Department of Justice  
Civil Division, Federal Programs Branch  
1100 L Street, N.W.  
Room 12102  
Washington, D.C. 20005  
Tel: (202) 616-8467 
Email: courtney.d.enlow@usdoj.gov 
 
Counsel for Defendant 
 
 
 
 
 
 
 
 
 
 
 
 
  
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ATTACHMENT 
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~12 pages 
~289 page 
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5.3.5 
 
Expanded sections for the Phase 1 / 2/ 3 study are below 
 
 
 
~31 pages 
~48 pages 
~2033 pages 
~1 page 
~3611 pages 
~1584 pages 
~ 2 pages 
~ 3697 pages 
~ 14 pages 
Index not being provided for 
section 5.3.1 (would need 
disclosure review first) 
~240 pages (~20 
journal articles) 
~38 pages 
Details of 5.3.5 
are provided 
below 
There are 2 
studies, shown 
here.  The record 
descriptions for 
each follow 
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That is the end of the first study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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See below for the Phase I/II study 
 
 
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