On Monday, the Food and Drug Administration (FDA) requested that the courts allow the agency to wait until the year 2076 to release all of the relevant documents regarding the approval of the vaccine developed by Pfizer and BioNTech, as reported by the Daily Caller.
The FDA made its request after a lawsuit was filed against the agency by the group Public Health Medical Professionals for Transparency (PHMPT). The PHMPT had previously made a Freedom of Information Act (FOIA) request on September 9th asking for the release of the vaccine approval documents; after the FDA denied the request, the group filed its lawsuit on September 16th.
The FDA concluded that there were roughly 329,000 pages in total that would qualify under this FOIA request. In its appeal to the courts, the agency said that, at most, employees would be able to “process and produce the non-exempt portions of responsive records at a rate of 500 pages per month.” Under this process, the FDA said that it would hand over prioritized documents to the plaintiff, and release non-exempt documents on a “rolling basis.”
“This rate is consistent with processing schedules entered by courts across the country in FOIA cases,” the FDA said in a statement. The FDA said that if they were forced to comply with the PHMPT’s request of a 4-month timeframe, then they would have to process at least 80,000 pages per month. The disagreement between the two parties led the FDA to request that the case be argued before a judge.
Although the PHMPT said in a statement that it does not doubt “the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” they nevertheless wanted access to the information in order to satisfy questions regarding the sufficiency of data that was used to approve the vaccine.
“After a license has been issued,” the lawsuit states, “the following data and information in the biological product file are immediately available for public disclosure unless extraordinary circumstances are shown.”
Aaron Siri, a lawyer with the firm that is representing PHMPT, said in a statement that “the FDA’s promise of transparency is, to put it mildly, a pile of illusions.”
“It took the FDA precisely 108 days from when Pfizer started producing the records for licensure to when the FDA licensed the Pfizer vaccine,” Siri continued. “Taking the FDA at its word, it conducted an intense, robust, thorough, and complete review and analysis of those documents in order to assure that the Pfizer vaccine was safe and effective for licensure. While it can conduct that intense review of Pfizer’s documents in 108 days, it now asks for over 20,000 days to make these documents available to the public.”