Public Health and Medical Professionals for Transparency (PHMPT) is a not-for-profit organization. It’s members include over 30 accomplished academics, professors, and scientists from the medical schools and related departments of our most prestigious universities, including Yale, Harvard, UCLA, UCSF, UCI and Brown.
These academics and scientists represent a cross section of every discipline relevant to the licensure of the Pfizer vaccine and include many of the best our country has to offer when it comes to reviewing and assessing the appropriateness and validity of the FDA’s decision-making in licensing of the Pfizer COVID Vaccine.
In furtherance of its mission, on August 27, 2021, PHMPT submitted the Freedom of Information Act (FOIA) Request to the FDA seeking all data and information pertaining to the application and approval of the Pfizer Vaccine. Federal law (21 C.F.R. § 601.51(e)) provides that: “After a license has been issued, the following data and information in the biological product file are immediately available for public disclosure unless extraordinary circumstances are shown.” PHMPT desires to perform its own independent analysis of the safety and efficacy the the vaccine, especially in light of the vaccine mandates being promulgated at the federal and state levels.
In the Second Joint Status Report following filing this case, the FDA assessed that there are more than 329,000 pages potentially responsive to the PHMPT FOIA request. The FDA asked that the Court limit the FOIA response to no more than 500 pages per month. This would be nearly 55 years or until about 2077.
The FDA lost the battle. On January 6, 2022 a federal judge soundly rejected the FDA’s request and ordered the FDA to produce all the data at a rate of 55,000 pages per month. In doing so the judge noted that “the Court recognizes the ‘unduly burdensome’ challenges that this FOIA request may present to the FDA.”
The January 6, 2022 order set a production schedule, which was partially modified on February 2, 2022. The production schedule required the FDA to “produce 80,000 pages on or before May 2, June 1, and July 1, 2022; 70,000 pages on or before August 1, 2022; and then 55,000 pages on or before the first business day of each month thereafter.”
On December 19, 2023, in a Joint Status Report, the FDA notified the Court that it had completed its production of responsive documents. However, on April 23, 2024, in a related case Plaintiff learned that the FDA may have identified but not produced an Emergency Use Authorization (“EUA”) file.
Thereafter, on July 17, 2024, in its response to Plaintiff’s adequacy-of-search letter, the FDA disclosed that it had in fact identified but not produced an EUA file for the Pfizer Vaccine. Because the Parties were unable to resolve this issue without court intervention, the matter was briefed. And on December 6, 2024, the Court entered an order finding that the EUA file was responsive to Plaintiff’s FOIA request and must be produced. The Court ordered the FDA to produce the EUA file on or before June 30, 2025.
This month marks three years after the 2022 court order, and the PHMPT and FDA continue litigating compliance with the federal law mandating the publics ability to review the FDA information used to justify approval of the Pfizer Vaccine. The FDA now requests that the Court not only delay the production of the EUA file, but indefinitely stay it. In its Cross-Motion for Summary Judgment, Plaintiff specifically requested that the Court order the FDA to produce the EUA file on or before February 20, 2025.
In denying the FDA’s recent request for a stay, U.S. District Judge Mark Pittman expressed his exhaustion with the agency’s “continued attempts to pause the production of information related to one of the preeminent events of our time – the Covid-19 pandemic.” He ordered that the FDA must release the requested “emergency use authorization” file by June 30, 2025.