Dr. Peter Marks, director of the Evaluation and Research Center of the Biological Center within the Food and Medicines Administration, answers a question during a Health, Education, Labor and Pensions of the Senate to discuss the ongoing federal response to COVID-19, in the United States Capitol in Washington, DC, May 11, 2021.
Greg Nash | Pool | Reuters
The main vaccine regulator of the Food and Drug Administration, Peter Marks, resigned, citing the “erroneous and relapse information of the Secretary of Human Human Services and Health, according to a renunciation letter obtained by CNBC.
For almost 10 years, Marks led the Evaluation and Research Center of the FDA Biological Center, a publication that included the evaluation of COVID-19 vaccines and the establishment of patterns for emerging treatments such as cell and gene therapies. A key figure in the FDA, the experts of the biopharma industry were closely observing the brands in the middle of the transition.
The Wall Street Journal first reported Marks's resignation, saying that an official of the Department of Health and Human Services gave Marks the opportunity to resign or be fired. Marks, the FDA and the Department of Health and Human Services did not immediately respond to a request for comments.
In his renunciation letter, addressed to the interim commissioner of the FDA, Sara Brenner, Marks praised the agency's work to issue the development of vaccines that met the standards of quality, safety, effectiveness expected by Americans and “undoubtedly reduce significantly the morbidity and mortality of COVID-19 in the United States and elsewhere.” He called advanced efforts on the adverse effects of “worrying” immunization, specifically citing the current measles outbreak as an example of the “clear danger” of “undermining confidence in well -established vaccines.”
“As you know, I was willing to work to address the secretary's concerns regarding the safety and transparency of vaccines when listening to the public and implementing a variety of different public meetings and commitments to the National Academy of Sciences, Engineering and Medicine,” Marks wrote. “However, it has become clear that truth and transparency do not want the secretary, but wishes the subordinate confirmation of his misinformation and lies.”
Marks was well known among the biofarma industry, regularly speaking in conferences about finding ways to accelerate the development of innovative therapies, particularly for rare diseases. His departure could further shake a biotechnology industry that has been defeated in recent years.
Last fall, speaking remotely at the Health Health Conference of Jefferies London, Marks said he planned to stay while welcome.
“I will stay all the time they consider me welcome to stay,” Marks said at that time, according to Endpoints News. “I think it is very important that people see that there is constant leadership here, that we are here to work with both sides of the hall.”
