The Food and Drug Administration on Nov. 15 asked a federal court to give it until the year 2076 to fully release the documents in their possession regarding the approval of Pfizer's Wuhan coronavirus (COVID-19) vaccine.
The request was made in response to the Freedom of Information Act (FOIA) lawsuit by a medical transparency group.
The government told the court that it has 329,000 pages of documents responsive to the FOIA request, and it proposed releasing 500 pages per month to allow for redactions of exempt material. At this rate, the FDA would be able to fully release the records in just under 55 years.
"By processing and making interim responses based on 500-page increments, FDA will be able to provide more pages to more requesters, thus avoiding a system where a few large requests monopolize finite processing resources and where fewer requesters’ requests are being fulfilled," wrote Department of Justice lawyers, pointing to other court decisions where the 500-page-per-month schedule was upheld.
While the 1967 FOIA law requires federal agencies to respond to information requests within 20 business days, the time it takes to gather the documents will vary "depending on the complexity of the request and any backlog of requests already pending at the agency."
The plaintiff in this case is the Public Health and Medical Professionals for Transparency (PHMPT), a group of doctors and scientists who filed a lawsuit after the FDA denied its request to expedite the release of records. The professionals involved included individuals from Yale, Harvard and UCLA.
The parties were unable to reach an agreement on a disclosure schedule and are seeking a hearing to argue their cases before the judge.
Pfizer vaccine approval questioned
"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," said Aaron Siri, whose firm is representing PHMPT.
"Taking the FDA at its word, it conducted an intense, robust, thorough and complete review and analysis of those documents 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."
The plaintiffs' lawyers argue that the request should be a top priority and that the FDA should release all 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," Siri said in court papers.
The FDA licensed the Pfizer COVID-19 vaccine under the Comirnaty label on August 23, less than four months after the pharmaceutical company began submitting documents for full approval of the drug. The said approval of the license led to an avalanche of mandates in the private and public sectors.
One of the companies involved in the trials of the vaccine said it was investigating alleged problems brought to light by a whistleblower who said that the trial was riddled with issues, including falsification of data. The whistleblower alerted the FDA and was fired within hours from Ventavia Research Group, which operated several of the Pfizer trial sites in the fall of 2020. (Related: Whistleblower: Pfizer and research partner falsified COVID-19 vaccine trials data.)
There are also accusations that the FDA did not inspect Ventavia's trial sites despite being alerted about the issues.
On the FDA's part, the agency said that while it couldn't comment on the Ventavia matter, it has "full confidence in the data that were used to support the Pfizer COVID-19 vaccine authorization and the Comirnaty approval."
As of November 14, there had been 256 million doses of Pfizer's COVID-19 vaccine administered in the U.S. alone.
"The entire purpose of the FOIA is to assure government transparency. 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," the plaintiffs argued.
U.S. District Judge Mark Pittman set a scheduling conference for December 14 in Fort Worth to discuss the timeline for processing the Pfizer documents.
Read more stories related to the coronavirus pandemic at Pandemic.news.
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