In November of 2020, the U.S. Food and Drug Administration (FDA) committed to transparency, open dialogue, and efficiency when dealing with decisions to grant emergency requests for COVID-19 vaccines.
“The FDA understands there is tremendous public interest regarding vaccines for COVID-19. We remain committed to keeping the public informed about the evaluation of the data of a potential COVID-19 vaccine, so that once available, the public and the medical community can have trust and confidence in receiving the vaccine for our families and ourselves.”FDA Commissioner Stephen M. Hahn, M.D.
Despite this promise to the American people, the FDA has now asked a United States Federal District Court for 55 years to produce the data and information it relied upon to license Pfizer’s COVID-19 vaccine, Comirnaty. To be clear, the FDA claims it conducted an intense review of these same documents in just 108 days to authorize Comirnaty in the first place.
In August of 2021, the non-profit organization Public Health and Medical Professionals for Transparency (PHMPT) requested data and information submitted to the FDA by Pfizer to license its COVID-19 vaccine, Comirnaty.
PHMPT was created “for the sole purpose of disseminating to the public the data and information in the biological product files for each of the COVID-19 vaccines.”
The FDA refused the request. It claimed that PHMPT failed to “demonstrate a compelling need that involves an imminent threat to the life or physical safety of an individual” or to show “that there exists an urgency to inform the public concerning actual or alleged Federal Government activity.”
In response, PHMPT sued the FDA in the U.S. District Court for the Northern District of Texas. In its Freedom of Information Act (FOIA) suit, PHMPT noted that under federal law, (1) information related to the safety and effectiveness of a biological product file, such as the vaccine Comirnaty, as well as (2) protocol for any tests and studies related to the vaccine is required to go public “unless extraordinary circumstances are shown.” 21 C.F.R. § 601.51(e).
Following the initiation of the suit, the FDA determined that there are over 329,000 pages (not including certain record types that are not paginated) that would potentially need to be disseminated. To comply with the FOIA request, the FDA proposed “to process and produce the non-exempt portions of responsive records at a rate of 500 pages per month.”
While 500 pages per month is consistent with many FOIA cases, it would mean that American citizens would need to wait 55 years to finally receive all the data related to Pfizer’s Comirnaty vaccine.
PHMPT has put in a request for a shorter timeline. It argues that basic liberty and government transparency demands a speedier response given that the federal government has rolled out numerous workplace mandates impacting over 100 million Americans and may yet target school children.
“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.”PHMPT v. FDA, Civil Action No. 4:21-cv-01058-P at 11.
PHMPT also noted in its request that the need for transparency is “heightened by the fact that the secretary of Health and Human Services (“HHS”), the FDA’s parent department, has granted Pfizer complete immunity from financial liability for any injury caused by its product.”
Under the HHS’s declaration, Pfizer cannot be sued by anyone receiving its Covid-19 vaccine for any injury. Pfizer also cannot be sued for willful misconduct regarding its vaccine unless HHS, which has been instrumental in promoting the product’s efficacy, agrees to bring such a claim. 42 U.S.C. § 247d-6d.
Given the high stakes surrounding the medical tool, PHMPT reiterated its request for speed. It noted that if the FDA has conducted the intense, robust, thorough, and complete review and analysis of the documents required to assure that the Pfizer vaccine was safe and effective for licensure, then it should “welcome” making the documents publically available.
Plaintiff respectfully requests that the Court enter an order requiring the FDA to produce all documents … on or before March 3, 2022…. To require less is to render FOIA meaningless, the FDA’s promise of transparency a lie, and to send a signal to every American that while the federal executive branch is shielding Pfizer from any liability for injuries from its product and requiring employers, schools, hospitals and the military to expel those that don’t receive this product, it is protecting the very documents Pfizer provided to our taxpayer-funded health agency to obtain licensure to be able to sell this product.PHMPT v. FDA, Civil Action No. 4:21-cv-01058-P at 13.
Post by: CJ Fisher