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In win for government transparency, federal judge orders the FDA to release all information on Pfizer vaccine approval in eight months


In response to a Freedom of Information Act (FOIA) request, the Food and Drug Administration (FDA) had proposed releasing just 500 pages of some 400,000 total pages of material per month about the Pfizer vaccine approval process, but a federal district judge this week ordered the agency to release 55,000 pages per month until complete, insisting that the public’s right to know is “of paramount importance.”

Quick Facts

Suzann Burk, head of the FDA’s Division of Disclosure and Oversight Management, argued that the FDA can only release 500 pages per month because it takes 8 minutes per page to review and the office only has 10 employees devoted to FOIA requests. That means it would take the agency 55 years to fully comply with the request.

“It is important for the FDA to perform a careful line-by-line, word-by-word review of all responsive records before producing them in response to a FOIA request,” she said.

Yet the FDA has previously released information at a much quicker pace, such as in the case of Treatment Action Group v. FDA, wherein the agency released 11,800 pages per month.

Aaron Siri, who represents the plaintiffs, said the proposed release of the documents was “so slow that the documents will not be fully produced until almost all of the scientists, attorneys, and most of the Americans that received Pfizer’s product will have died of old age.”

Siri called the Department of Justice’s claim that the FOIA request should not be expedited “dystopian for the government to give Pfizer billions, mandate Americans to take its product, prohibit Americans from suing for harms, but yet refuse to let Americans see the data underlying its licensure.”

U.S. District Judge Mark Pittman ordered the FDA to release 12,000 pages by January 31 and be prepared to release 55,000 pages each month starting on March 1, which if followed would complete the release in just 8 months. The court order quotes former President John F. Kennedy, who said, “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.”

The judge said that FOIA requests are intended to “pierce the veil of administrative secrecy,” and “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.’”

The order continued, “Here, the Court recognizes the ‘unduly burdensome’ challenges that this FOIA request may present to the FDA. But, as expressed at the scheduling conference, 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….’”

Americans are entitled to know what their government is doing behind closed doors and their reasons for doing it, and the FOIA process is critical to holding the government accountable. While transparency is always paramount, it is especially so if the government is going to mandate that everyone take a medical intervention that was developed and approved in record time.

The idea that it would take decades to release this information is ridiculous and troubling, and fortunately the judge in this case recognized that. The federal government has too much power and money — money it obtains from taxpayers — to not be held in check, and the way that is accomplished is through public transparency in a timely fashion, not when the government feels like it and certainly not 50 years in the future.

In a free society, the government can never be allowed to hide from accountability by purposefully keeping the American public in the dark.

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