FDA’s Peter Marks Resigns Amid Conflict Over Vaccine Policy and Leadership Changes at HHS
Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER), submitted his resignation on Friday, effective immediately. His departure follows a request to step down from officials within the Trump administration, according to individuals familiar with the matter.
Dr. Marks oversaw vaccine approvals, gene therapies, and the U.S. blood supply, and played a central role in the nation’s response to the COVID-19 pandemic, particularly through Operation Warp Speed. His resignation comes amid growing internal tensions within the Department of Health and Human Services (HHS), particularly regarding vaccine policy under the leadership of newly appointed HHS Secretary Robert F. Kennedy Jr.
In his resignation letter, obtained by STAT News, Dr. Marks cited concerns about the direction of the agency, claiming that his attempts to promote transparency and scientific dialogue around vaccine safety were not supported. “It has become clear that truth and transparency are not desired by the Secretary,” Marks wrote, asserting that the expectation instead was for confirmation of “misinformation.”
Secretary Kennedy has made headlines in recent weeks by suspending and canceling several vaccine advisory meetings, calling for a reevaluation of vaccine safety studies, and forming a new office within the CDC to study vaccine injuries. In addition, David Geier, a figure associated with the anti-vaccine movement, was hired as a senior data analyst in the Secretary’s office. These moves represent a shift in federal health policy direction and have stirred concern among various health experts.
Dr. Marks’ resignation also comes as the U.S. sees a resurgence of measles cases, with the CDC reporting nearly 500 confirmed cases across 19 states and two fatalities. The CDC warns the actual number could be higher due to underreporting. Public health officials have historically emphasized the need for widespread vaccination to prevent such outbreaks.
Reaction to Dr. Marks’ departure was swift. Former FDA commissioners and public health leaders expressed concern about the implications for scientific independence and vaccine policy. Dr. Scott Gottlieb, who previously served as FDA Commissioner, praised Marks for his leadership in gene therapy and called him a driving force behind advances in treatments for diseases like pediatric leukemia and sickle cell anemia. Others, including Dr. Jesse Goodman and John Crowley of the Biotechnology Innovation Organization, warned that the loss of experienced leadership could negatively impact the pace of innovation and public trust in medical regulation.
Critics of the decision to remove Marks have called for congressional oversight and inquiry. Some have questioned whether political considerations are compromising the independence of federal science agencies.
Dr. Marks was a prominent figure in the rapid development and approval of mRNA vaccines during the COVID-19 pandemic. His departure leaves uncertainty around the FDA’s future direction on vaccine oversight and biologics development, especially as the agency navigates new leadership under incoming FDA Commissioner Marty Makary.
As the broader public health community reacts to this leadership change, the situation reflects ongoing tensions between evolving public sentiment, federal policy, and scientific consensus. DailyClout will continue monitoring developments surrounding HHS, FDA leadership, and federal vaccine policy.
Rewritten from Statnews