Peter Marks, who headed the FDA’s Center for Biologics Evaluation and Research before being forced to resign in March, said the agency’s new risk-based COVID-19 vaccine framework contradicts the current administration’s push for transparency and gold-standard science.
Peter Marks, former director of the FDA’s Center for Biologics Evaluation and Research, has mostly stayed quiet since his ouster from the agency in March. But Wednesday, Marks spoke out against the recent changes to the agency’s COVID-19 vaccine framework, noting that these represent “a dramatic departure” from the FDA’s previous standards, policies and scope.
In the past, the different roles for the FDA and CDC in vaccine policy have been “reasonably well defined,” Marks wrote in an editorial for the New England Journal of Medicine on Wednesday. That is, the FDA has purview over approving products and ensuring that companies’ data support their label claims, while the CDC makes recommendations in the interest of public health.
The FDA’s new COVID-19 framework, however, falls beyond the usual scope of the agency, according to Marks. “With it, the FDA has taken on aspects of policymaking that have previously been in the domain of the CDC.”
FDA Commissioner Marty Makary and current CBER Director Vinay Prasad—Marks’ successor—announced this new vaccine framework last month, also in an editorial for NEJM. In it, they stated that the agency would apply a risk-based strategy for approving new COVID-19 shots, focusing on adults 65 and up and in people six months through 64 years who are at a high risk of severe outcomes.
This new philosophy, the two officials wrote, “will inform future directions for the FDA, but more important, they will provide information that is desperately craved by health care providers and the American people.”
Then, late last month, Health Secretary Robert F. Kennedy Jr. unilately removed the CDC’s recommendation for healthy children and pregnant women—the latter group a particular surprise to both CDC staffers and several prominent medical organizations, including The American College of Obstetricians and Gynecologists.
In his editorial, Marks also pointed out the lack of transparency with which these changes were made. “There was no discussion of this change in policy purview” with the FDA’s and CDC’s independent vaccine advisors—nor with the public,” he wrote. “The new framework also seems to ignore evidence, oftentimes coming from the FDA and CDC themselves, showing that serious adverse events are “uncommon” for COVID-19 vaccines in the U.S., according to Marks, who also noted that “there is no evidence to suggest that vaccination has any adverse effects for pregnant women.”
“Although the current federal administration has repeatedly stated that it is committed to ‘transparency and gold-standard science,’ the issuance of the new policy appears to achieve neither objective,” Marks wrote.
With his editorial, Marks joins the growing chorus of former government employees voicing disappointment with the agency’s recent direction. Earlier this month, for instance, four former officials penned an editorial in the Journal of the American Medical Association, arguing that politics has seeped into the drug approval process.
They pointed to Novavax’s COVID-19 shot, whose approval was delayed due to interference from political appointees, and ultimately granted, though with different parameters than Novavax had applied for—under circumstances they said deviated from the FDA’s normal process.
“They strayed from the process in an area where the secretary has very specific ideas,” Peter Lurie, co-author of the JAMA editorial and associate commissioner at the FDA from 2014 to 2017, told BioSpace. “If it’s a harbinger of what’s to come in vaccines or elsewhere, the very integrity of the approval process is at stake.”
Former FDA Commissioner Robert Califf has also previously raised concerns about the current direction of the FDA, particularly the steep cuts at the agency. “The FDA as we’ve known it is finished, with most of the leaders with institutional knowledge and a deep understanding of product development and safety no longer employed,” he wrote in a LinkedIn post in April. “I believe that history will see this a huge mistake.”
