Pfizer-FDA FOIA Request

Pfizer-FDA FOIA Request

Re: Freedom of Information Request for Pfizer’s data for Covid Vaccine FDA approval

Facts of the Case

Dates: Sept 16 2021
Location: Texas, USA
Court: US District Court Northern District Of Texas
Case #: 4:21-cv-01058-P
Plaintiff: PHMPT

Defendant: FDA
Trial Type: FOIAR
Judge:
Status: End
Verdict: For The Plaintiff

Background

On Sept 16, 2021, the group Public Health & Medical Professionals For Transparency (PHMPT) filed an Freedom of Information Act request against the Food & Drug Administration (FDA), essentially for documents that Pfizer submitted to gain approval for their fast-tracked covid vaccine. (1)

As stated in their complaint this is actually a follow up request:

On September 9, 2021, the FDA denied PHMPT’s request for expedited processing on the basis that PHMPT did “not demonstrate[] a compelling need that involves an imminent threat to the life or physical safety of an individual” or “that there exists an urgency to inform the public concerning actual or alleged Federal Government activity.” PHMPT brings this action to challenge the FDA’s determination and seeks an order compelling the FDA to produce responsive records on an expedited basis.(1)

PHMPT’s members include doctors and scientists from all over the world (such as Drs Doshi, McCullough, Keil, Bridle, etc) and from universities such as Yale, Brown, Oxford, etc (1)

Significance

This is a request for transparency regarding information that has lead to the largest drug trial in human history.

Plaintiff’s Argument

The request states (among others):

On August 23, 2021, the FDA approved the Pfizer-BioNTech COVID-19 Vaccine, marketed as Comirnaty (the “Pfizer Vaccine”) for individuals 16 years of age and older.
Although the FDA asserts that the Pfizer Vaccine “meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product[,]” numerous public health officials, media outlets, journalists, scientists, politicians, public figures, and others with large social or media platforms have publicly raised questions regarding the sufficiency of the data and information, the adequacy of the review, and the appropriateness of the analyses relied upon by the FDA to license the Pfizer Vaccine.
In furtherance of its mission, and in an effort to ensure that the FDA acts in furtherance of its commitment to transparency,4 PHMPT seeks to obtain the data and information relied upon by the FDA to license the Pfizer Vaccine. The importance of releasing to the public this information is also recognized under federal law which provides that: “After a license has been issued, the following data and information in the biological product file are immediately available for public disclosure unless extraordinary circumstances are shown: (1) All safety and effectiveness data and information. (2) A protocol for a test or study . . .” 21 C.F.R. § 601.51(e).
PHMPT therefore issued a request to the FDA pursuant to the Freedom of Information Act (5 U.S.C. § 552, as amended) (“FOIA”) for “[a]ll data and information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e)5 with the exception of publicly available reports on the Vaccine Adverse Events Reporting System.6” (the “FOIARequest”).

Defendant’s Argument

…More information needed…

Decision

Two months and one day after it was sued, and close to 3 months since it licensed Pfizer’s Covid-19 vaccine, the FDA released the first round of documents it reviewed before licensing this product. The production consisted of 91 pdf pages, one xpt file, and one txt file. You can download them here. (2)

Aftermath

On January 6, 2021, attorney Aaron Siri, reported on his site that the court ordered the FDA to produce all the data at a clip of 55,000 pages per month which would see all documents released in 8 months instead of 75 years. [3] See the Case details here.