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Biotech group warns exit of top FDA vaccine official will ‘erode scientific standards’

The US biotech industry’s main lobby group issued a rare warning following the forced and abrupt resignation of the nation’s top vaccine official at the Food and Drug Administration (FDA), saying the loss of his experienced leadership would “erode scientific standards” and affect the development of transformative therapies to fight disease.

The statement, issued on Saturday by John Crowley of the Biotechnology Innovation Organization (BIO), followed the news a day earlier that Dr Peter Marks – who led the FDA division that ensured the safety of vaccines – had resigned over what he called “misinformation and lies” from health secretary Robert F Kennedy Jr.

It was a rare admonition from a sector that has largely been silent in the face of the second Donald Trump presidential administration’s first months in office, including cuts to medical and scientific research and jobs at the National Institutes of Health (NIH).

“We are deeply concerned that the loss of experienced leadership at the FDA will erode scientific standards and broadly [affect] the development of new, transformative therapies to fight diseases for the American people,” said the statement from Crowley, BIO’s president and chief executive officer. “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.”

Crowley added that his organization – the largest of its kind in the world – was committed to working with the Trump administration “to support and enable a strengthened and modernized FDA”.

Marks had served as the FDA’s top vaccine official since 2016, earning global praise during Trump’s first presidency for having a hand in Operation Warp Speed, the initiative that developed, manufactured and helped distribute the vaccines protecting the public from Covid-19.

Citing people familiar with the matter, the Wall Street Journal, New York Times and other media outlets reported Friday that Marks had been faced with a choice to resign or be fired by an official at the Kennedy-led Health and Human Services (HHS) department. Marks chose to resign from the FDA, a key federal agency within the HHS, setting 5 April as his last day at the agency.

The resignation letter that Marks handed in took aim at Kennedy, who has spent years sowing doubt about the efficacy and safety of vaccines that protect communities from preventable diseases.

“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,” Marks’s resignation letter said. “Undermining confidence in well-established vaccines that have met the high standards for quality, safety and effectiveness that have been in place for decades at FDA is irresponsible, detrimental to public health and a clear danger to our nation’s health, safety and security.”

Marks’s resignation came three days after the US Senate confirmed Dr Martin Makary – a surgeon at Johns Hopkins University – as the commissioner of the FDA.

Dr Jonathan Howard, a New York neurologist who has closely tracked medical misinformation, has been critical of Makary. Howard has alleged that Makary sought to try to convince people that the world overreacted to the Covid-19 pandemic.

Similarly, in 2021, a group led by Kennedy called for the emergency approval granted to Covid-19 vaccines to be revoked, claiming that their benefits did not outweigh their “risks of serious adverse events or deaths”.

Studies later disproved that claim. A Commonwealth Fund study found that Covid-19 vaccines saved more than 3 million lives in the US and prevented more than 18m hospitalizations through November 2022.

Nonetheless, after promising that he would not change the FDA’s vaccine approval process, Kennedy received US Senate approval to serve as Trump’s health secretary. Among the senators to support him was Bill Cassidy, a Louisiana Republican who is a medical physician and frequently speaks about the importance of avoiding deaths and sickness from diseases that can be prevented by vaccines.

Cassidy on Saturday published a statement saying Marks’s resignation was “a loss to the FDA”.

“Commissioner Makary and secretary Kennedy should replace him with someone of similar stature and credibility among the scientific community, who will lead without bias,” Cassidy’s statement said.