Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research within the Food and Drug Administration answers a question during a Senate Health, Education, Labor and Pensions Committee hearing to discuss the on-going federal response to COVID-19, at the U.S. Capitol in Washington, D.C., May 11, 2021.
Greg Nash | Pool | Reuters
The Food and Drug Administration’s top vaccine regulator Peter Marks has resigned, citing Health and Human Services Secretary Robert F. Kennedy Jr.’s “misinformation and lies” around immunization, according to a resignation letter obtained by CNBC.
For nearly 10 years, Marks led the FDA’s Center for Biologics Evaluation and Research, a post that included evaluating Covid-19 vaccines and establishing guidelines for emerging treatments like cell and gene therapies. A key figure at the FDA, biopharma industry insiders were closely watching Marks amid the transition.
The Wall Street Journal first reported Marks’s resignation, saying an official of the Department of Health and Human Services gave Marks the chance to resign or be fired. Marks, the FDA, and the Department of Health and Human Services did not immediately respond to a request for comment.
In his resignation letter, addressed to acting FDA Commissioner Sara Brenner, Marks praised the agency’s staff’s work to expedite the development of vaccines that met the standards for quality, safety, effectiveness expected by Americans and “undoubtedly markedly reduced morbidity and mortality from COVID-19 in the United States and elsewhere.” He called efforts being advanced on the adverse health effects of immunization “concerning,” specifically citing the current measles outbreak as an example of the “clear danger” of “undermining confidence in well-established vaccines.”
“As you are aware, I was willing to work to address the Secretary’s concerns regarding vaccine safety and transparency by hearing from the public and implementing a variety of different public meetings and engagements with the National Academy of Sciences, Engineering, and Medicine,” Marks wrote. “However, it has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies.”
Marks was well-known among the biopharma industry, regularly speaking at conferences about finding ways to accelerate the development of innovative therapies, particularly for rare diseases. His departure could further shake a biotech industry that’s been beaten down over the past few years.
Last fall, speaking remotely at the Jefferies London Healthcare Conference, Marks said he planned to stay as long as he was welcome.
“I will stay around as long as I’m considered to be welcome to stay around,” Marks said at the time, according to Endpoints News. “I think it’s very important that people see that there’s constant leadership here — that we are here to work with either side of the aisle.”
