Judge Gives FDA 8 Months to Release Pfizer Vaccine Data After Agency Requested 75 Years

FILE - Syringes with doses of the Pfizer COVID-19 vaccine are shown next to vaccination ca
Ted S. Warren, File/AP

A federal judge on Thursday ordered the U.S. Food and Drug Administration (FDA) to release Pfizer vaccine data within approximately eight months after the agency had asked for 75 years to fully comply with an extensive public records request.

President Donald Trump appointee Judge Mark Pittman ordered the agency to produce 12,000 pages of Public Health and Medical Professionals for Transparency’s (PHMPT) request by January 31, 2022, followed by 55,000 pages every 30 days. The first round is due by March 1, 2022.

Pittman wrote in part:

“Open government is fundamentally an American issue”—it is neither a Republican nor a Democrat issue. As James Madison wrote, “[a] popular Government, without popular information, or the means of acquiring it, is but a Prologue to a Farce or a Tragedy; or, perhaps, both. Knowledge will forever govern ignorance: And a people who mean to be their own Governors, must arm themselves with the power which knowledge gives.”

John F. Kennedy likewise recognized that “a nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people.” And, particularly appropriate in this case, John McCain (correctly) noted that “[e]xcessive administrative secrecy . . . feeds conspiracy theories and reduces the public’s confidence in the government.”

PHMPT’s attorney Aaron Siri in court filings estimated that the size of the FOIA request “appears to be at least 451,000 pages,” which would take roughly 75 years to complete at the FDA’s proposed rate of 500 pages released per month. According to the court-ordered production schedule, PHMPT should receive 451,000 pages by October 1, 2022.

Pittman concluded that while the request may be “unduly burdensome,” releasing the data is of “paramount public importance.” The FDA previously argued the request would burden its Access Litigation and Freedom of Information Branch (the “Branch”), which at the time had “a total of ten employees, including the director and two trainees.” The plaintiff, PHMPT, argued the FDA has a multi-billion dollar budget and is capable of hiring more employees as needed, or asking Congress for a bigger budget.

“There may not be a “more important issue at the Food and Drug Administration . . . than the pandemic, the Pfizer vaccine, getting every American vaccinated, [and] making sure that the American public is assured that this was not [] rush[ed] on behalf of the United States . . . . .” the judge wrote, quoting from an earlier scheduling conference.

The lawsuit stems from a FOIA request from PHMPT, a group which is comprised of at least 30 scientists and professors from universities like Harvard, Yale, Brown, and UCLA. The group says it is a nonprofit that takes no partisan position on the data but “exists solely to obtain and disseminate the data relied upon by the FDA to license COVID-19 vaccines” for the sake of transparency.

After the FDA denied the group an expedited records request of all data pertaining to the licensing of Pfizer’s vaccine, PHMPT filed a lawsuit in September in the U.S. District Court for the Northern District of Texas. The group contends that reviewing the information will “settle the ongoing public debate regarding the adequacy of the FDA’s review process.” The nonprofit also emphasized the urgency of the release, noting that the ability for a majority of Americans to participate in civil society, “and even the exercise of basic liberty rights, are now contingent on receiving this product.”

The FDA initially replied asking Pittman to grant the agency 55 years to fully release the data due to the volume of the request, court documents show. However, in a December 6 brief, the FDA admitted it had found tens of thousands more pages of data and 126 data files to add to the request, meaning the 500-page per month timeline would conclude potentially in 2096. Arguably, by then most of the members of PHMPT would no longer be alive.

Pittman acknowledged the need for timeliness in his order, quoting court precedent to back up his reasoning. “Congress has long recognized that ‘information is often useful only if it is timely’ and that therefore, ‘excessive delay by the agency in its response is often tantamount to denial’”, he wrote.

In an exclusive statement to Breitbart News on Friday, Siri said Pittman’s decision is a “great win for transparency.”

“Americans are mandated to receive this product and cannot sue Pfizer for harm it may cause, so we are pleased that at least the public and independent scientists will have access to the data underlying its licensure,” he continued. 

Breitbart News reached out to the FDA for comment on the lawsuit and also asked whether the agency plans to hire more employees to handle the FOIA request. A spokesperson for the agency said, “The FDA cannot comment on pending, ongoing, or possible litigation.”

The case is Public Health and Medical Professionals for Transparency v. Food and Drug Administration, No. 4:21-cv-1058 in the United State District Court for the Northern District of Texas. 

Katherine Hamilton is a political reporter for Breitbart News. You can follow her on Twitter.


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