A dozen former leaders of the Food and Drug Administration on Wednesday warned that plans for a stricter approach to vaccine approvals risks undermining the nation’s ability to fight infectious diseases and could threaten the health of vulnerable Americans.
In a New England Journal of Medicine article, the former FDA commissioners wrote that they were “deeply concerned” with new plans the nation’s top vaccine regulator, Vinay Prasad, laid out in a leaked internal email Friday. They argued that his approach represents a major shift that could delay the arrival of vaccines better matched for evolving viruses, make it potentially prohibitively expensive for new shots to come to market and slow expanded approval of vaccines for more people.
Prasad is challenging long-standing vaccine policy, urging the FDA to rethink its framework for annual flu shots, examining whether Americans should receive multiple vaccines at the same time and requiring larger studies to gain approval for certain shots.
“These measures, and the unilateral way they are being imposed, undermine the public interest,” the commissioners wrote in an article titled “A Threat to Evidence-Based Vaccine Policy and Public Health Security at the FDA.”
“They are the latest in a series of troubling changes at the FDA, including substantial departures of FDA staff, that could diminish both the FDA’s strength and Americans’ health and safety,” the former officials added.
The warning from both former permanent and acting FDA commissioners — including Scott Gottlieb, Norman “Ned” Sharpless and Brett Giroir, who all served in the role during President Donald Trump’s first administration — is the latest of several admonishments issued by former health officials from both parties.
Nine former leaders of the Centers for Disease Control and Prevention raised concerns about Health Secretary Robert F. Kennedy Jr.’s leadership days after the August firing of then-CDC Director Susan Monarez. Six former surgeons general, including Jerome Adams, who worked in the first Trump administration, contended in an October op-ed that Kennedy’s actions are “endangering the health of the nation.”
Kennedy, the founder of a prominent anti-vaccine group, has a lengthy history of disparaging vaccines. He has countered that he is simply seeking better data before recommending shots. Prasad’s vaccine strategy aligns with some changes Kennedy and his allies have sought for years.
Some Kennedy allies have previously criticized some of the former FDA commissioners who co-wrote the NEJM article, arguing they are part of a revolving door of agency officials who later join the boards of pharmaceutical and other companies they used to regulate.
In his internal email, Prasad said the new approach to vaccines was necessary after his team concluded that coronavirus vaccinations had contributed to the deaths of at least 10 children. He did not detail the evidence behind the claims. Public health experts have called on the agency to release more details on how it performed its review and on the planned changes to vaccine regulation.
“[FDA] staff will be tasked with writing guidelines to reflect these changes, and the mission of CBER will change to reflect this worldview,” Prasad wrote, referring to the Center for Biologics Evaluation and Research. “Never again will the US FDA commissioner have to himself find deaths in children for staff to identify it.” He added that staff who disagree with the core principles of his new approach should submit their resignation letters.
The former commissioners wrote that the reports of potential vaccine deaths to federal health agencies had been carefully reviewed by FDA staff, “who drew different conclusions.” They wrote that Prasad’s memo did not indicate why the new assessment “should justify wholesale rewriting of vaccine regulation.” In totality, those changes mean a “substantially higher and more subjective approval bar,” they wrote.
Prasad argued in his internal email that the country’s vaccine regulation related to the coronavirus “may have harmed more children than we saved.”
“This requires humility and introspection,” he added.
CDC staff over the summer presented data showing that at least 25 children died who had covid-associated hospitalizations since July 2023. The number was probably an undercount, according to staff, and of the 16 children old enough for vaccination, none were up-to-date.
The commissioners also expressed concern that the planned changes lacked transparency, arguing the agency’s expert advisers and the public should have a say in major revisions to FDA decision-making.
“The people most affected by the FDA’s proposed framework will include older Americans and those with weakened immune systems who rely most on the protection that timely and updated vaccines can offer,” they wrote.
The concerns from former commissioners represents the latest flash point for an agency rocked by turmoil this year amid layoffs and the departures of senior officials.
On Tuesday, the nation’s top drug regulator, Richard Pazdur, decided to retire three weeks after taking the job amid tensions with FDA Commissioner Marty Makary. Pazdur — who has worked at the FDA for more than 25 years — had privately raised concerns about the legality and pace of agency plans to expedite drug approval decisions.
Pazdur had replaced George Tidmarsh, who resigned last month amid scrutiny over his critique of a treatment made by a company that alleged he had a vendetta against its board chair.
Dan Diamond contributed to this report.
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