The resignation of Peter Marks, long-time director of the US Food and Drug Administration’s (FDA) centre responsible for assessing vaccines and other biological products, has exacerbated growing concerns within the US biotechnology industry and beyond.
Marks, who joined the FDA as deputy director of its Center for Biologics Evaluation and Research (CBER) in 2012, and was promoted to director in 2016, explained in his 28 March resignation letter that he is leaving the agency over insurmountable conflicts with the head of the FDA’s parent agency, the Department of Health and Human Services (HHS). Robert F Kennedy Jr, who is a very public vaccine critic and a conspiracy theorist, was confirmed as HHS Secretary on 13 February.
‘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,’ wrote Marks, who was a leader in the US government’s programme that fast-tracked development of vaccines against Covid-19 during the pandemic. His resignation is effective from 5 April.
‘Undermining confidence in well-established vaccines … is irresponsible, detrimental to public health, and a clear danger to our nation’s health, safety, and security,’ Marks noted.
It is imperative that we retain and recruit scientific expertise and strong leadership at our health agencies
John Crowley, Biotechnology Industry Organization
The US Biotechnology Innovation Organization (BIO) trade group, expressed serious concern about Marks’ departure. The organisation’s president, John Crowley, issued a statement describing his leadership at the FDA as ‘extraordinary’, adding that Marks helped shepherd in ‘a new era of scientific breakthroughs’ at the agency, from vaccines to cell and gene therapies.
‘We are deeply concerned that the loss of experienced leadership at the FDA will erode scientific standards and broadly impact the development of new, transformative therapies to fight diseases for the American people,’ Crowley stated. ‘It is imperative that we retain and recruit scientific expertise and strong leadership at our health agencies and that the high standards that are the hallmark of these health institutions are upheld and advanced.’
Under a dramatic new restructuring plan, HHS is laying off 10,000 full-time workers. This includes 3500 full-time FDA staff - about 19% to the agency’s workforce. HHS said these reductions at the FDA will not affect drug, medical device, or food reviewers, or inspectors. In February, hundreds of probationary workers at the FDA were fired, some of whom were hired back about a week later.
Concern about Marks’ exit from the FDA extends well beyond the BIO. ‘This is a huge loss for FDA regulatory science,’ Ed Belongia, an infectious disease epidemiologist with long-term research on vaccine safety and effectiveness funded by the US Centers for Disease Control and Prevention, wrote on the social media platform Bluesky. ‘Peter Marks was one of the Covid heroes while RFK Jr was spreading disinformation.’
Marks is among several prominent government agency leaders who have stepped down in recent months. The FDA’s deputy commissioner for human foods, Jim Jones, resigned in February, reportedly saying in his resignation letter that ‘indiscriminate’ firings across the agency would make it ‘fruitless’ for him to continue in the role.
Also in February, Lawrence Tabak and Michael Lauer, who respectively served as deputy director and head of extramural research at the National Institutes of Health, both suddenly announced their retirements.
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