The U.S. Food and Drug Administration (FDA) asked a federal judge in Texas to throw out a public information document request by a group of scientists and medical experts seeking licensing information the agency relied on in approving the Pfizer-BioNTech COVID-19 vaccine in 2020.
As concerns grew over the efficacy and safety of coronavirus shots, Public Health and Medical Professionals for Transparency (PHMPT) in late 2021 sued the Biden FDA to release records relating to the vaccine approval process.
A 55-Year Wait
The FDA responded that it could take at least 55 years to process and release the information after receiving PHMPT’s original request under the Freedom of Information Act in 2021, Reuters reported.
PHMPT’s lawsuit alleges “the medical and scientific community and the public have a substantial interest in reviewing the data and information underlying the FDA’s approval of Pfizer’s Vaccine.”
The FDA now says it has produced more than a million documents in the case. The scientists and medical professionals are suing the FDA to release the rest of the records.
“Despite years of litigation and the Court’s order to produce all clinical trial documents, the FDA continues to withhold over a million pages of trial documents,” Aaron Siri, PHMPT’s attorney, said in a statement after the judge’s October 17 ruling.
New FDA Sheriff
It is not clear what direction the lawsuit could take under a new administration. President-elect Donald Trump who takes office on January 20 nominated Marty Makary, M.D. to head the FDA. Makary, a Johns Hopkins University surgeon has been an outspoken critic of pandemic policies.
If anything, the lawsuit calls attention to much-needed reform at the FDA, says Jeff Stier, a senior fellow at the Center for Consumer Choice.
“The Biden administration’s rush to impose vaccine mandates and demand vaccination of younger, healthier Americans was misguided,” said Stier. “Further examination of what led to the decisions is not only warranted but essential in order to learn from mistakes made.”
“The FDA has a greater responsibility than under its standard procedure if it’s going to allow the use of a dangerous experimental product while suppressing safe repurposed drugs, as do the other government agencies that pushed or even mandated this use,” said Jane Orien, M.D., the executive director of the Association of American Physicians and Surgeons.
Bonner Russell Cohen, Ph.D., (bcohen@nationalcenter.org) is a senior fellow at the National Center for Public Policy Research.