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.
FOIA provides for “expedited processing of request for records” upon a showing of “compelling need.” PHMPT requested expedited processing of the FOIA Request, which was rejected by the FDA. Thus, PHMPT filed a lawsuit in federal court, seeking to obtain the data and information relied upon by the FDA to license the Pfizer Vaccine by way of expedited processing. The FDA denied the expedited processing request.
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 asks 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, 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 burden some’ challenges that this FOIA request may present to the FDA. “
Nonetheless, the Court went on to say that “Open government is fundamentally an American issue” – it is neither a Republican nor a Democrat issue. As James Madison wrote, “[a] popular Government, without popular information, or the means of acquiring it, is but a Prologue to a Farce or a Tragedy; or, perhaps, both. Knowledge will forever govern ignorance: And a people who mean to be their own Governors, must arm themselves with the power which knowledge gives.” John F. Kennedy likewise recognized that “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.” And, particularly appropriate in this case, John McCain (correctly) noted that “[e]xcessive administrative secrecy . . . feeds conspiracy theories and reduces the public’s confidence in the government.”
Echoing these sentiments, “[t]he basic purpose of FOIA is to ensure an informed citizenry, [which is] vital to the functioning of a democratic society.”
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.’ ”
Attorney Aaron Siri, who represents the plaintiff in the case, said “This is a great win for transparency and removes one of the strangleholds federal ‘health’ authorities have had on the data needed for independent scientists to offer solutions and address serious issues with the current vaccine program – issues which include waning immunity, variants evading vaccine immunity, and, as the CDC has confirmed, that the vaccines do not prevent transmission.”