Public health and regulatory experts signed an open letter to FDA Commissioner Dr. Stephen Hahn on Friday, demanding transparency and outlining steps to maintain the agency’s integrity.
The 33 signees of the #ProtectTheFDA letter included Dr. Luciana Borio, former chief scientist for the US Food and Drug Administration; Dr. Aaron Kesselheim, head of the Program On Regulation, Therapeutics, and Law at Harvard Medical School and Brigham and Women’s Hospital; Dr. Peter Lurie, president of the Center for Science in the Public Interest; and Dr. Eric Topol, director of the Scripps Research Translational Institute.
“The data and reasoning on which FDA bases its actions must be transparent and made reasonably available at the time the decision is made,” the letter said.
If decisions are made on data that’s evolving quickly, the authors said, there should be “a clear follow-up plan” that explains how more data will be collected and the process for re-evaluating the decision. “The FDA must enforce these timelines and be ready to modify or reverse its initial decision if better data require doing so,” the letter added.
The authors said that undermining the FDA by allowing political interference would harm the public.
The letter listed eight points for the FDA to act on, including insisting that “the President and his White House advisers refrain from criticizing federal scientists, their scientific conclusions, measurements, or methodologies” and sharing “key data and consultation with scientists from … the NIAID, the NIH, the CDC, FDA’s Vaccines and Related Products Advisory Committee, and the Infectious Diseases Society of America” before making any decision on authorizing a Covid-19 vaccine.
The signees of the letter also called on the FDA to “commit to publicly challenging claims by any government officials that are inconsistent with the evidence evaluated by FDA scientists in issuing its decisions.”