FDA Asks Court to Delay Full Release of Documents on Pfizer COVID Biologic for 55 Years

by TVR Staff

Published November 21, 2021 | Law, Federal Agencies

In response to a Freedom of Information Act (FOIA) lawsuit filed on Sept. 16, 2021 against the U.S. Food and Drug Administration (FDA) by a medical transparency group of more than 30 physicians, professors and scientists from various universities in the United States, the FDA has asked a federal judge to delay the full release of all documents in the agency’s possession related to its Aug. 3, 2021 licensing of the “Pfizer-BioNTech COVID-19 Vaccine” (also known as BNT162b2) until the year 2076.^{1 2 3 4}

The lawsuit, filed in U.S. District Court for the Northern District of Texas by the nonprofit Public Health

and Medical Professionals for Transparency (PHMPT), was prompted after the FDA denied a request by the PHMPT to expedite the release of the documents. The FDA and the PHMPT were unable to agree on a disclosure schedule.^{1 2 3 5}

Attorneys for the U.S. Department of Justice (DOJ) representing the FDA propose that the FDA be allowed to release 500 pages per month on a “rolling basis.”^{2 3} DOJ attorneys wrote:

By processing and making interim responses based on 500-page increments, FDA will be able to provide more pages to more requesters, thus avoiding a system where a few large requests monopolize finite processing resources and where fewer requesters’ requests are being fulfilled.²

But attorney Aaron Siri, whose firm, Siri & Glimstad LLP of New York, is representing PHMPT in the lawsuit, notes:

It took the FDA precisely 108 days from when Pfizer started producing the records for licensure to when the FDA licensed the Pfizer vaccine. Taking the FDA at its word, it conducted an intense, robust, thorough, and complete review and analysis of those documents in order to assure that the Pfizer vaccine was safe and effective for licensure. While it can conduct that intense review of Pfizer’s documents in 108 days, it now asks for over 20,000 days to make these documents available to the public.³

FOIA Requests Require Fast Turnaround

The FOIA law, passed in 1967, requires agencies of the federal government to respond to FOIA requests within 20 business days unless there are “unusual circumstances.”^{2 6} Such circumstances include one or more of the following situations:

• • the component needs to search for and collect responsive records from a field office or other entity separate from the office processing the request;
  • the request involves a “voluminous” amount of records that must be located, compiled, and reviewed; or
  • the component needs to consult with another federal agency or two or more Department of Justice components that have a substantial interest in the responsive information.⁶

DOJ attorneys contend that the PHMPT is seeking approximately 329,000 pages of documents related to the “Pfizer-BioNTech COVID-19 Vaccine” and that the FDA cannot release the information without first reviewing it to redact “confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials.”²

But plaintiff attorneys Siri and John Howie of Howie Law, PC of Dallas, Texas argue:

The entire purpose of the FOIA is to assure government transparency. It is difficult to imagine a greater need for transparency than immediate disclosure of the documents relied upon by the FDA to license a product that is now being mandated to over 100 million Americans under penalty of losing their careers, their income, their military service status, and far worse.²

Transparency on the Pfizer COVID Biologic is Important

Given the importance of this issue and what is at stake for so many Americans, Siri and Howie point out that the FDA “should have been preparing to release (data on the “Pfizer-BioNTech COVID-19 Vaccine”) simultaneously with the licensure [of the biologic]. Instead, it has done the opposite.” They add that the FDA itself has said that there is “nothing more important than the licensure of this vaccine and being transparent about this vaccine.”²

“Reviewing this information will settle the ongoing public debate regarding the adequacy of the FDA’s review process,” Siri and Howie said.²

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  Aaron Siri, BioNTech, BNT162b2, COVID-19, Department of Justice, DOJ, FDA, FOIA, Food and Drug Administration, Freedom of Information Act, Howie Law, John Howie, Marco Cáceres, National Vaccine Information Center, NVIC, Pfizer, PHMPT, Public Health and Medical Professionals for Transparency, Siri & Glimstad LLP, The Vaccine Reaction, U.S. District Court for the Northern District of Texas