Legal Push: Vaccine Data Transparency at the FDA

In response to my FOIA request for the data relied upon for the Pfizer vaccine approval, the FDA indicated in would release it all... by the year 2076 (yes, you read that right).

Along with 30 other academic physicians and scientists I submitted a Freedom of Information Act (FOIA) request to the FDA for the Pfizer vaccine data. This week, in response, the FDA claimed that it will take them 55 years to release this data, though it only took them 108 days to review this same data for the vaccine approval process. Here’s the full story, along with the initial commentary in the press on the FDA’s absurd response.

In previous posts I’ve described my legal action pushing the CDC to acknowledge natural immunity and describing their telling response to a FOIA request we submitted. Keep in mind that the CDC is the federal agency that makes recommendations on the use of vaccines after they are approved, whereas the FDA is the federal agency responsible for approving vaccines (as well as medications and medical devices) for use. Both agencies, along with the NIH (and Anthony Fauci’s NAIAD division of NIH), report to the HHS Secretary, Xavier Becerra—a lawyer with no public health experience whose previous term as Attorney General of my home state of CA was disastrous.

But back to the FDA story. In September I organized 30 distinguished academic physicians and scientist colleagues to form Public Health and Medical Professionals for Transparency. This group included, among other luminaries, my friends Harvey Risch of Yale, Andrew Bostom of Brown, Joseph Ladapo of UCLA (who has since been appointed Surgeon General of Florida), Paul Alexander, formerly of HHS and WHO, Aditi Bhargava of UCSF, and other scientists from the U.S., Canada, Denmark, Australia, Germany, and the University of Oxford in the U.K.

With the help of my lawyers, Aaron Siri and Elizabeth Brehm, we submitted a FOIA request to the FDA for all the data relied upon to authorize Pfizer’s Covid vaccine. While this information was not available while the vaccine was only approved under Emergency Use Authorization (EUA), under federal law, the FDA was required to make this data publicly available once it received full approval, which happened in August. The law is crystal clear on this point: our FOIA request was not at all legally complicated, and the FDA’s lawyers at the Department of Justice are well aware of this.

As we describe on our website: “The organization takes no position on the data other than that it should be made publicly available to allow independent experts to conduct their own review and analyses. Any data received will be made public.” This is likewise uncontroversial, since transparency is widely regarded as a core ethical principle of all public health initiatives. It is one of the central ethical principles articulated, for example, in the University of California’s “Allocation of Scarce Critical Resources under Crisis Standards of Care,” the ventilator triage policy that I helped draft for the UC’s hospitals last year (see 2.f below):

What happened next is well-summarized in this Reuter’s article, published yesterday with the fitting title, “Wait what? FDA wants 55 years to process FOIA request over vaccine data”:

Freedom of Information Act requests are rarely speedy, but when a group of scientists asked the federal government to share the data it relied upon in licensing Pfizer’s COVID-19 vaccine, the response went beyond typical bureaucratic foot-dragging.

As in 55 years beyond.

That’s how long the Food & Drug Administration in court papers this week proposes it should be given to review and release the trove of vaccine-related documents responsive to the request. If a federal judge in Texas agrees, plaintiffs Public Health and Medical Professionals for Transparency can expect to see the full record in 2076. […]

The FDA can’t simply turn the documents over wholesale. The records must be reviewed to redact “confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials,” wrote DOJ lawyers in a joint status report filed Monday. The FDA proposes releasing 500 pages per month on a rolling basis, noting that the branch that would handle the review has only 10 employees and is currently processing about 400 other FOIA requests. […]

Plaintiffs' lawyers argue that their request should be top priority, and that the FDA should release all the material no later than 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 also argue that Title 21, subchapter F of the FDA’s own regulations stipulates that the agency “is to make ‘immediately available’ all documents underlying licensure of a vaccine.” Given the intense public interest in the vaccine, the plaintiffs’ lawyers say that the FDA “should have been preparing to release (the data) simultaneously with the licensure. Instead, it has done the opposite.”

To meet the plaintiffs’ proposed FOIA deadline, the FDA would have to process a daunting 80,000 pages a month. But the plaintiffs note that the FDA has 18,000 employees and a budget of $6 billion and “has itself said that there is nothing more important than the licensure of this vaccine and being transparent about this 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 to consider the timeline for processing the documents.

Commentary from journalists, physicians, scientists, and politicians was swift and strong as the story circulated:

I look forward to seeing the DOJ lawyers in court, and will keep you updated on this story as the legal proceedings unfold.