The newly appointed Food and Drug Administration (FDA) Commissioner, Marty Makary, has agreed to oust top vaccine regulator Peter Marks, sending shockwaves through the scientific community and pharmaceutical industry. The forced resignation marks Makary’s first major act as commissioner and is seen as a significant move by Secretary Robert F. Kennedy Jr.’s Health and Human Services Department to remake the government’s approach to vaccines.
Makary had previously agreed with Kennedy to push out Marks, who led the FDA’s vaccine division for over eight years. However, Kennedy made the final call to force Marks’ exit after Makary consented. The decision has alarmed lawmakers and industry experts, who see it as an effort to lay the groundwork for remaking the government’s approach to vaccines.
Marks is credited with helping establish the Operation Warp Speed initiative during President Donald Trump’s first term that delivered a Covid vaccine in a matter of months. He had won the trust of FDA commissioners and lawmakers in both parties, developing a reputation over more than 12 years as a fierce defender of scientific independence and the agency’s rigorous approach to developing and testing vaccines.
Kennedy had long expressed skepticism of Marks and the FDA’s approach to vaccines, often accusing the agency without evidence of downplaying the health risks they believe the shots pose. The HHS secretary has also ordered a large-scale study on potential links between vaccines and autism, despite extensive research that has failed to find evidence of such a connection.
The ouster of Marks has generated outsize concern within the FDA and across the healthcare landscape. Vaccine manufacturers Moderna and Novavax saw their stocks drop sharply when the market opened Monday. Biotechnology Innovation Organization President and CEO John Crowley said the loss of leadership at the FDA could erode scientific standards and impact the development of new medicines.
Mark McClellan, who ran the FDA during the George W. Bush administration, praised Marks’ commitment to bringing the best science and data to the development and availability of lifesaving biomedical technologies. “His decade-long leadership at the FDA is a big reason why the FDA is the gold standard for advancing the most innovative breakthrough medicines,” McClellan said.
The move has also sparked criticism from lawmakers, with Senator Bill Cassidy (R-La.) stating that Makary and Kennedy should “replace him with someone of similar stature and credibility amongst the scientific community.”
Source: https://www.politico.com/news/2025/03/31/new-fda-commissioner-signed-off-on-ousting-top-vaccine-regulator-after-private-swearing-in-00260582