Right off the bat, the high-profile departure of Peter Marks, M.D., Ph.D., former director of the FDA’s Center for Biologics Evaluation and Research, was linked to his advocacy for vaccines, which opposes certain viewpoints held by Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr.
Now, Marks is making it clear: His abrupt resignation came after he held his ground trying to block Kennedy from unfettered access to a federal vaccine safety database, according to an April 7 interview with the Associated Press.
Previously, Marks had only alluded to RFK Jr. in explaining his sudden FDA departure, specifically calling out the HHS secretary’s desire for “subservient confirmation of his misinformation and lies” in his resignation letter.
Now, the former director has told AP that he did attempt to “make nice” with RFK Jr. before things came to a boiling point. Part of those efforts included a “vaccine transparency action plan” aimed at helping address RFK Jr.’s long-held concerns about vaccine safety, Marks told the news service.
The plan hinged on revamping the HHS’s Vaccine Adverse Events Reports System (VAERS), a surveillance program established in 1990 and managed jointly by the FDA and the Centers for Disease Control and Prevention. Anyone can submit a report to VAERS, meaning the program can identify patterns but not accurately detect if a vaccination causes an adverse event, according to the website.
While Marks was “was willing to compromise” on making the system more transparent, he refused to give Kennedy’s team full access to the database, he told AP. Beyond concerns over the sensitive data held in the database, Marks cited a lack of trust and his belief that “they’d write over it or erase the whole database,” AP reported.
The former director was eventually called to a meeting at HHS headquarters, where he was told by an official that “he wants you gone,” Marks told AP. Marks added that he believes this was a reference to RFK Jr.
“It was pretty clear that either I was going to resign or they were going to fire me,” Marks told AP.
RFK Jr.’s plans for vaccines have been a point of contention since his Senate confirmation hearings, when he was grilled on his history of vaccine skepticism and anti-vaccine advocacy. Since taking office, RFK Jr.’s only “increased the pace by which he intends to minimize the use of vaccines in this country,” Marks said to AP.
So far, RFK Jr. has pledged to investigate several potential ties to the “drastic rise in chronic disease,” including childhood vaccination schedules. Two vaccine advisory meetings have been put on hold under his leadership, as well.
Previously, he has opposed vaccine mandates for COVID-19 and promoted the disproven claim that childhood immunizations can cause autism.
More recently, as a deadly measles outbreak spreads across Texas and other states, the HHS secretary endorsed measles, mumps and rubella vaccines in a social media post, calling them “the most effective way to prevent the spread of measles.” Later, RFK Jr. highlighted alternative, unproven measles remedies in a separate post.
Marks is far from the only federal health leader to depart after the Trump administration’s transition into office. Leadership within the FDA has been “decapitated,” according to Janet Woodcock, M.D., former acting FDA commissioner and former principal deputy commissioner of food and drugs. The leadership changes and resulting tumult has been “somewhat deliberate,” Woodcock said at a April 7 panel at the Biopharma Congress.
During his stint at the FDA, Marks advocated for the agency’s accelerated approval pathway for rare diseases and gene therapies and developed the concept of Operation Warp Speed to accelerate COVID-19 vaccine development.
FDA insider Scott Steele, Ph.D., has been tapped as acting CBER director in the wake of Marks’ departure.
