One of the FDA’s recently departed top officials is weighing in on the wide-ranging staff cuts at the agency and how they could imperil the drug approval process that has served as the global regulatory standard for decades.
On a recent call with analysts at BMO Capital Markets, an enigmatic “former director” at the FDA’s Center for Biologics Evaluation and Research (CBER)—who resigned in March—raised concerns that the roughly 3,500 layoffs at the agency under Department of Health and Human Services Secretary Robert F. Kennedy Jr. could jeopardize upcoming drug reviews starting around 2026 or 2027, the analysts summarized in a note to investors Wednesday.
The BMO team never outright identified the expert it interviewed, though all signs point to it being Peter Marks, M.D., Ph.D., who announced his departure as head of the CBER in late March.
While agency staff remain committed to their work, the message from the former director was clear: The FDA is undergoing a rapid transformation, and the externally facing changes may just be the "tip of the iceberg," the BMO analysts wrote.
Though the staff cuts are likely to disrupt various aspects of the FDA’s work, the agency’s review teams are still committed to meeting established timelines of 10 months and six months for standard and priority reviews, respectively, the ex-CBER interviewee told BMO analysts.
That said, it remains unclear whether political meddling by new FDA leadership in review decisions could add to those timelines or raise the evidence benchmark currently required for approvals, the former director told BMO. If political appointees at the agency do throw a spanner in the works, companies could be looking at more FDA drug rejections in the future, the expert said.
That may have been the situation for Novavax’s COVID-19 vaccine, which was expected to win a full approval from the FDA by April 1. The FDA ultimately let the decision date slip by despite Novavax's regular contact with the agency on a filing the biotech felt was ready for approval, the company told Fierce Pharma.
According to Politico, the FDA’s principal deputy commissioner, Sara Brenner, M.D.—who was elevated to lead the agency on an acting basis shortly after President Donald Trump’s inauguration—was the one to intervene in the approval process by calling for more data on Novavax’s shot.
Innovation in peril
Breaking down the drug classes and indications in most imminent danger, BMO’s interviewee noted that development programs using innovative or small population studies, like those for rare diseases, are more vulnerable to review delays given the heightened importance of frequent regulatory interactions.
Advisory committee meetings, which are assembled by the FDA to consider a drug’s safety and efficacy prior to an approval decision, could also be scrutinized or politicized by the new regime, the expert warned.
As for the FDA’s accelerated approval pathway, the former CBER director figures that framework will remain intact thanks to widespread bipartisan support. Still, comments by some of the new top brass at the FDA are enough to raise concern, the expert told BMO.
Public comments from Trump administration appointees on alleged overuse of accelerated approvals could threaten the pathway’s availability moving forward and affect adherence to prior agreements, the ex-CBER chief told BMO.
According to BMO's overview of the discussion, the ex-CBER director flagged the risk of the agency pulling approved drugs from the market, citing the refusal of new FDA Commissioner Martin Makary, M.D., to commit to upholding previous approvals at his nomination hearing before the Senate Health, Education, Labor and Pensions Committee in early March.
While the full impact of the FDA staff cuts aren’t expected to set in until next year at least, the former CBER director said drugmakers and others in the industry should proactively engage policymakers about their concerns to spotlight risks to the system, BMO analysts wrote.