Peter Marks, who has led the FDA's Center for Biologics Evaluation and Research (CBER) since 2016, was forced to resign on Friday, sending biotechnology stocks tumbling and raising serious concerns about the future of regulatory science at the agency.
According to multiple reports, Marks was given an ultimatum to resign or be fired, despite his previous statements indicating willingness to remain in his role during the Trump administration. His final day at the agency will be Saturday, April 5.
Industry Reaction and Market Impact
The news of Marks' departure triggered immediate market reactions. Shares of gene therapy and vaccine-focused companies including Taysha Gene Therapies, Solid Biosciences, Sarepta Therapeutics, and Novavax fell between 5% and 10% in pre-market trading on Monday.
BMO Capital Markets characterized the situation as a "new wave of uncertainty at FDA" in a Monday investor note, adding: "We view this departure as a significant negative for the biopharma and biotech sectors, as FDA's independence rooted in sound scientific rigor is critical for their efficient functioning."
Truist Securities analysts expressed similar concerns, noting that "our industry conversations over the weekend suggest the resignation of Dr. Peter Marks was a negative surprise," and predicting volatility for companies with vaccine businesses as investors process the implications.
Conflict Over Vaccine Safety and Scientific Integrity
In his resignation letter, Marks directly addressed the conflict with newly confirmed Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., who has a well-documented history of vaccine skepticism that was highlighted during his Senate confirmation hearings.
Marks wrote that while he was "willing to work" to address Kennedy's concerns about vaccination safety, "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."
Jeremy Levin, CEO of Ovid Therapeutics, expressed "grave concern" over the resignation in a LinkedIn post, calling it "a stark and unequivocal warning" that "the FDA, long held as the gold standard in global regulatory science, is now under threat from political interference and the systematic distortion of scientific truth."
Broader Pattern of FDA Leadership Changes
Marks' forced departure follows several other significant leadership changes at the FDA. Patrizia Cavazzoni left her position as head of the Center for Drug Evaluation and Research (CDER) in January, later joining Pfizer as chief medical officer.
According to a William Blair investor note, Oncology Center of Excellence (OCE) deputy directors Paul Kluetz and Marc Theoret also plan to leave the agency "imminently," with concerns that OCE Director Richard Pazdur "may also be at risk of leaving."
Implications for Regulatory Pathways
During his tenure, Marks had been a strong advocate for accelerated approval pathways and regulatory flexibility for gene therapies targeting rare diseases. His support for innovative approaches to drug development had made him a valued partner for companies working on cutting-edge therapies.
Industry analysts now worry about the future of these pathways. Truist Securities expressed concern that "a CBER yes-person may expand the influence of RFK Jr.'s vaccine rhetoric," potentially compromising the scientific basis of regulatory decisions.
Broader Context of FDA Changes
The leadership shakeup comes amid other significant changes at the FDA. In February, shortly after Kennedy's confirmation as HHS Secretary, the agency implemented job cuts that raised eyebrows across the industry.
"The extent and the rapidity of the actions taken has been remarkable, and that has perhaps led to, in many cases, the concern that there is no understanding of exactly why they're being done," Levin told BioSpace regarding these earlier changes.
Looking to the Future
As the industry absorbs the implications of Marks' departure, attention turns to who might replace him and what direction CBER might take under new leadership. The selection of his successor will likely be closely watched as a signal of the administration's regulatory priorities.
For companies developing biologics, vaccines, and gene therapies, the leadership change introduces new uncertainty into an already complex regulatory landscape. Many will be watching closely to see whether the FDA can maintain its scientific independence and continue to support innovation while ensuring product safety and efficacy.
