Many people and news media have raised questions about the unethical practices that are followed by FDA. Since the start of COVID pandemic many things came to attention like approval of drugs and vaccine without proper scrutiny and now recently the war between NIH and Moderna over patent and role of scientists unfolds many things that are undergoing in US healthcare system.
Recently, according to the documents filed (PDF) in a U.S. District Court for the Northern District of Texas, the FDA asked a federal judge for 55 years to complete a FOIA request for data and information on the approval of Pfizer-BioNTech’s COVID-19 vaccine, Comirnaty. If the judge grants the FDA’s request, the plaintiffs, Public Health and Medical Professionals for Transparency, would have to wait until the U.S. celebrates its 300th year anniversary in 2076 to view the full report.
The FDA’s request comes about a month after the plaintiffs, comprising more than 30 professors and scientists from some of the country’s top schools who also include overseas professors from the UK, Germany, Denmark, Australia and Canada, filed suit (PDF) to expedite their FOIA request. The group originally asked for documentation after the vaccine’s approval in August, but the FDA has yet to turn anything over.
The plaintiffs’ lawyers say the FDA needs to fork over the information to “settle the ongoing public debate” around the agency’s review process as well as to confirm its conclusion that the Pfizer vaccine is safe, effective and worthy of the public’s trust. “The entire purpose of the FOIA is to assure government transparency,” they continued. “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.” They also argue that Title 21, subchapter F of the FDA’s own regulations stipulates that the agency “is to make ‘immediately available’ all documents underlying licensure of a vaccine.”
Given the intense public interest in the vaccine, the plaintiffs’ lawyers say that the FDA “should have been preparing to release (the data) simultaneously with the licensure. Instead, it has done the opposite.”
Two months and one day after it was sued, and close to 3 months since it licensed Pfizer’s Covid-19 vaccine, the FDA released the first round of documents it reviewed before licensing this product. The production consisted of 91 pdf pages and according to observations, in the 2 ½ months following EUA, Pfizer received a total of 42,086 reports containing 158,893 “events.” Most of these reports were from the U.S. and disproportionately involved women (29,914 vs. 9,182 provided by men) and those between 31 and 50 years old (13,886 vs 21,325 for all other age groups combined, with another 6,876 whose ages were unknown). Also, 25,957 of the events were classified as “Nervous system disorders”.