Nearly three months after the U.S. Food and Drug Administration licensed the Pfizer COVID injection, the agency has released the first 91 out of tens of thousands of documents it reviewed before approving it for emergency use.
Last week, court documents revealed the FDA was asking the court to schedule a monthly release of the documents over the next 55 years. This means the “full transparency” the FDA promised the American public would not be fulfilled until the year 2076.
The FDA was sued soon after it approved the injection for not providing a single page of documentation relating to that decision beforehand. According to a status report filed Nov. 15, “FDA proposes to work through the list of documents that Plaintiff requested FDA prioritize for production in order of priority at a rate of 500 pages per month,” since this rate is “consistent with processing schedules entered by courts across the country in FOIA cases.”
The plaintiffs, a group of 30 scientists, academics, and professors under the name Public Health and Medical Professionals for Transparency (referred to as PHMPT in the report), filed the lawsuit on August 27. Since the agency did not release a single document since this group’s open records request, made almost three months ago, they asked the court to give the FDA until March 3, 2022 to fulfill the records request.
The agency responsible for approving a brand new pharmaceutical they knew would be immediately mandated for millions of Americans complained that the plaintiffs were requesting they “process and produce” more than 80,000 pages a month, claiming they do not have the personnel to redact sensitive information from the records at that rate.
The PHMPT has argued that since it only took the FDA 108 days to conduct what it claims is a “rigorous” examination of the documents to determine whether Pfizer’s product was safe to approve, it should be able to release documents to the public in a similar timeframe. But the agency claims this argument is “specious,” as its information specialists conduct an “entirely different” kind of review when deciding what information must be kept confidential.
The FDA also cited an unrelated decision by the D.C. Circuit Court, which stated that “another agency’s policy of processing 500 pages per request per month… ‘serves to promote efficient responses to a larger number of requesters,’” and that allowing this plaintiff to similarly “jump to the head of the FOIA processing line would upset the agency’s processes and be detrimental to the other expedited requesters.”
PHMPT is arguing a “compelling need” for expediting processing, as their Freedom of Information Act request “concerns a matter of current exigency to the American public.” In the FDA’s letter to the group denying their request for expedited processing, they denied any such urgency to inform the public and claimed PHMPT “failed to “demonstrate a compelling need that involves an imminent threat to the life or physical safety of an individual.”
It’s audacious for the FDA to claim this request for transparency isn’t meeting “a compelling need” to inform the public, given these are the documents that led the FDA to approve a product with dire alleged medical consequences for some recipients (such as myocarditis or stroke) and far-reaching social consequences. COVID shots have effectively created apartheid communities in parts of the country that exclude those who decline the shot from many indoor public places and activities that constitute a normal life.
The FDA has said they are committed to “ensuring full transparency, dialogue and efficiency.” Acting FDA Commissioner Janet Woodcock was quoted in the PHMPT’s complaint as assuring the public they “can be very confident that [the Pfizer vaccine] meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”
Particularly if the FDA was this confident, they should have been working on processing related documents as soon as the drug was approved on August 23 to bolster trust in Pfizer’s mRNA product. Instead, it seems the FDA wants to slow-walk “transparency” until all the people responsible for approving this product are dead.
To say the public has an urgent need to see every related document forthwith would be an understatement. People are losing their jobs, military service members are losing their benefits, and Americans are losing access to basic life activities such as places to eat, schools, and gyms if they have concerns about accepting these vaccinations.
The FDA’s alleged inability to process 80,000 pages of records a month begs an important practical question, as well: it is 2021, and all this redaction appears to be done by human hand. Yet there are several redaction software programs on the market, including at least one the company explicitly states can redact medical records and clinical research. Why is one of the most important regulatory bodies in the world using anachronistic processes that hold up FOIA requests for months or years instead of cutting-edge technology that could ensure speedy public availability of important records?
Lagging decades behind modern technology is characteristic of government bureaucracies, but in this case it isn’t just an inconvenience. The FDA is leveraging these outdated processes to avoid accountability for people whose decisions are affecting all of society, and it shouldn’t be tolerated.
Members of Congress should apply pressure to the administration and the FDA and introduce legislation, if necessary, to ensure the redaction of records subject to FOIA are done in the most efficient way possible. The public was promised a “safe and effective vaccine” and they deserve nothing less than full transparency as to how the FDA made that determination.