A federal judge has ruled that the Food and Drug Administration (FDA) must speed up its processing of a Freedom of Information Act (FOIA) request for hundreds of thousands of pages of COVID-19 vaccine data.
Although the government rarely processes FOIA requests efficiently, the FDA argued in court that it needed 55 years to review and release the trove of documents.
The whole record wouldn’t have been available to the public until 2076.
Now, instead of producing 500 pages of data submitted by Pfizer to the FDA per month, the FDA has to share what it received from the pharmaceutical company at a rate of 55,000 pages per month.
The ruling follows a lawsuit filed by a nonprofit organization called Public Health and Medical Professionals for Transparency, which was formed to promote transparency of the COVID-19 vaccine data used to secure Emergency Use Authorization. In its lawsuit, which was filed in September, the PHMPT claimed that under federal law, the data and information in the biological product file that was submitted to the FDA are expected to be available for public disclosure unless extraordinary circumstances have been shown. The judge presiding over the lawsuit agreed.
U.S. District Judge Mark Pittman found that the Freedom of Information Act filed by PHMPT “is of paramount public importance.” The judge’s ruling demands that the FDA make the data publicly available within a span of eight months.
In part, Pittman wrote in his decision that “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.”
The FDA has not disputed that the data should be made available to the public. However, the regulatory agency has claimed that each page of the file must be closely reviewed in order to redact confidential details or trade secrets that could be exposed.
As BioSpace previously reported, the FDA said there are more than 329,000 pages related to the Pfizer vaccine. The agency said its team is short-staffed. The FDA said it has a 10-person team handling FOIA requests, and there are more than 400 requests that team is addressing. The agency did offer to release 12,000 pages of data and then an additional 500 pages per month on a rolling basis in order to assuage the plaintiffs.
Pittman’s order may be read in its entirety here.