More than 30 professors and scientists have filed a Freedom of Information Act, asking the FDA to share the data it used to approve Pfizer’s Covid vaccine. The FDA wants 55 years to comply.
Yes, you read that right. 55 years.
What’s Going On with the Freedom of Information Act Request?
A group of more than 30 professors and scientists from universities like Yale, Harvard, UCLA, and Brown, as well as from the UK, Germany, Denmark, Australia, and Canada filed the Freedom of Information Act (FOIA) suit in September. They asked the U.S. District Court for the Northern District of Texas for expedited access to the Food and Drug Administration’s data on the Pfizer Covid vaccine and their licensure process.
While the 1967 FOIA law requires federal agencies to respond within 20 business days, the FDA proposes it should get 55 years to review and release all the related documents. They claim they need that much time to process the roughly 329,000 pages of related information, which includes redacting trade secrets, confidential business information, and the personal information of clinical trial patients. Instead, the FDA proposes releasing 500 pages a month, citing a personnel issue (only 10 employees in that branch) and a backlog of over 400 other FOIA requests.
But to counter this objection, the FDA has 18,000 employees and a $6 billion budget. Surely they can find a few more people to help out.
The plaintiffs’ lawyers argue that their request should be prioritized and ask that the FDA release all the material by March 3, 2022.
“This 108-day period is the same amount of time it took the FDA to review the responsive documents for the far more intricate task of licensing Pfizer’s COVID-19 vaccine,” wrote Aaron Siri of Siri & Glimstad in New York and John Howie of Howie Law in Dallas in court papers.
“The entire purpose of the FOIA is to assure government transparency,” they continued. “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.”
They further argue that Title 21, subchapter F of the FDA’s own regulations requires the agency “to make ‘immediately available’ all documents underlying licensure of a vaccine."
Transparency Will Calm Skepticism, Delay Will Only Make It Worse
Given the debate and skepticism surrounding the Covid vaccine, the plaintiffs' lawyers claim the FDA “should have been preparing to release (the data) simultaneously with the licensure. Instead, it has done the opposite.”
Additionally, they claim that complying with the FOIA request will help calm vaccine skepticism by proving that the shot is indeed “safe and effective and, thus, increase confidence in the Pfizer vaccine.”
As Siri and Howe argue, “Reviewing this information will settle the ongoing public debate regarding the adequacy of the FDA’s review process.”
U.S. District Judge Mark Pittman has set a scheduling conference for December 14 in Fort Worth, TX to consider the timeline for the FDA to process its documents.