Is the FDA About to Break?
Job cuts at the FDA spark concern, with Robert Califf saying the agency as we know it is “finished.”
Stephanie Vine | | 3 min read | Hot Topic
Posting on LinkedIn, Robert Califf said: “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.”
Thousands of jobs have been cut at the Department of Health and Human Services (HHS) under restructuring by Robert F. Kennedy Jr. and Elon Musk’s Department of Government Efficiency (DOGE). The FDA is losing 3,500 employees; the CDC is losing 2,400; NIH is losing 1,200; and the CMS is losing 300. A fact sheet says that the reductions at the FDA will not impact inspections, or reviewers, but can the agency continue operating as normal with such a significant loss of personnel?
Workers reportedly arrived on Tuesday April 2 as usual, only to find that their badges no longer worked – and were stopped by security from entering the building. That’s when they found out they had been let go. According to NBC News, jobs have been “eliminated at offices overseeing the approval of new drugs, providing health insurance and responding to infectious disease outbreaks.” Other affected departments include communications teams, the CDC’s Freedom of Information Office, the Office of Inspections and Investigations, the entire Lead Poisoning Prevention and Surveillance branch, and FDA staff involved in user fee negotiations, among others.
However, RFK Jr. has since admitted that around 20 percent of the firings were a mistake, with some employees now being asked to return. He told reporters in Virginia: “Personnel that should not have been cut, were cut. We're reinstating them. And that was always the plan. Part of the DOGE, we talked about this from the beginning, is we're going to do 80 percent cuts, but 20 percent of those are going to have to be reinstated, because we'll make mistakes.”
On top of other disruption, such as the resignation of Peter Marks, what do the changes at the FDA mean for drug approvals?
John Crowley, President and CEO of the Biotechnology Innovation Organization, released a statement on Marks’ resignation, saying: “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.”
And despite HHS saying the cuts shouldn’t impact approvals, it’s hard to believe that business will continue as normal. Novavax recently reported that the FDA had missed the target deadline of April 1, 2025 for a decision on the BLA for the company’s COVID-19 vaccine. A statement said: “As of Tuesday, April 1, we had responded to all of the FDA’s information requests and we believe that our BLA is ready for approval. As of today, we continue to wait on action from the agency and have not yet received an official decision from the U.S. FDA.”
The FDA has reportedly said that any delays are a “result of scientific review,” but Reuters has reported that FDA staff are struggling to meet product review deadlines after the layoffs.
What are your thoughts on that? Let me know: [email protected].
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