Late last week, three US congressional representatives sent a scathing letter to Food and Drug Administration (FDA) Commissioner Martin Makary, MD, MPH, condemning an agency email that contained “inaccuracies, misinformation, and unsupported claims regarding the agency’s regulation of vaccines, and asserting an unproven link between COVID-19 vaccines and pediatric deaths.”
The letter authors were Frank Pallone Jr. (D-NJ), Energy and Commerce Committee ranking member, and ranking members of the Health Subcommittee (Diana DeGette [D-CO]) and the Oversight and Investigations Subcommittee (Yvette D. Clarke [D-NY]).
The missive described “a troubling trend under your [Makary’s] leadership—of the agency making policy announcements with zero transparency regarding its decision-making process, zero public access to the ‘evidence’ it is relying on, and zero opportunity for the public to provide input.”
Lack of data supporting changes, claims
Specifically, the letter centered on an internal memo that FDA Center for Biologics Evaluation and Research Director Vinay Prasad, MD, MPH, sent to agency staff on proposed changes to vaccine regulations and an unproven link between COVID-19 vaccine and 10 child deaths.
Pallone and colleagues pointed out that the purported research findings Prasad cited weren’t published in a peer-reviewed journal and that Prasad’s claim about COVID-19 vaccine deaths wasn’t grounded in evidence.
Please provide the exact statutory and regulatory citations and explain how those authorities permit FDA to forego formal rulemaking, public comment, and processes outline in statute.
“In fact, Dr. Prasad concedes as much in the next sentence, by saying the relation of these deaths to vaccination is only ‘possible,’” they wrote. “Meanwhile, you [Makary] and Dr. Prasad have treated the fact that 183 children died of COVID-19 in the United States from 2020 to 2022 as, in effect, irrelevant.”
Prasad’s email also proposed changes to vaccine regulations such as more stringent requirements for authorizing vaccines for pregnant women and an altered seasonal flu vaccine approval process.
The authors ended the letter with demands for data supporting these assertions and proposed changes: “Please provide the exact statutory and regulatory citations and explain how those authorities permit FDA to forego formal rulemaking, public comment, and processes outline in statute.”