Key takeaways:
- Martin Makary, MD, MPH, has reportedly resigned.
- Inconsistency was a major component of his tenure, an expert said.
Martin Makary, MD, MPH, is resigning as FDA commissioner.
Politico was first to report the news on Tuesday, citing an administration official who was granted anonymity. The official told Politico that HHS Secretary Robert F. Kennedy Jr. made a decision months ago to “move on from Makary,” but the president also had to sign off.
Kyle Diamantas, JD, will now lead the FDA as an acting commissioner, according to Politico. Diamantas is currently the FDA’s deputy commissioner for human foods.
The FDA has not yet responded to Healio’s request to confirm the reports.
Arthur L. Caplan, PhD, a professor and founding head of the division of medical ethics at NYU Grossman School of Medicine, told Healio that “it’s clear there’s a lot of dissatisfaction with [Makary], and has been for some time.”
“I think the main reason for that is he’s been inconsistent at times, trying to approve drugs or speed up pathways — at other times, hindering drugs or treatments for approval,” he said. “Patient groups don’t understand what the hang up is. They’ve been pushing hard against that. One thing the FDA needs is consistency. Manufacturers want it; they need to know where the goal posts are to enable them to get across the approval line. Patients want more and more to be allowed to take risks with things that look promising. He was very inconsistent in response to that wish.”
The other issue, Caplan said, is that “other things have slowed down because of cuts in personnel. That makes the biotech and pharmaceutical industries very anxious. I think Trump himself has been for some time on the side of hurrying up drug approval processes. I’m expecting that’s what we’re going to see in the next nominee to be the commissioner: speed over, if you will, caution.”
Editor’s Note: This is a developing story. Please check back soon for more details.
For more information:
Arthur L. Caplan, PhD, can be reached at primarycare@healio.com.
Sources/Disclosures
Source:
Healio Interviews
Reference:
Disclosures:
Caplan reports no relevant financial disclosures.
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