FDA's head of device safety fired; top food official resigns

The FDA's head of medical device safety, Ross "Rusty" Segan, was among those fired by the Trump administration, my colleague Lizzy Lawrence exclusively reports.

Employees across the FDA received termination notices last weekend as part of the efforts by Elon Musk and the U.S. DOGE Service to cut probationary government employees. (Segan started his role in September, so he was in his probationary two-year period.)

The cuts hit the FDA's medical device center particularly hard, impacting product reviewers and researchers of AI-enabled medical technology. Notably, the center has a strained relationship with one of Musk's companies, Neuralink, which is testing a brain implant. Read more.

Relatedly, my colleague Matt Herper spoke with the FDA's former top food official, Jim Jones, who said he resigned this week because he thought the Trump cuts imperil the agenda set forth by new health secretary, Robert F. Kennedy Jr.

"I'm not sure if it's a lack of understanding of how things get done, or it's that there's really no seriousness about what they want to get done," he said. "I don't know. But I didn't want to spend the next six months of my career on activities that are fundamentally about dismantling an organization, as opposed to working on the stated agenda." Read more from that interview.

opinion

Recursion CEO calls on industry to mitigate NIH funding gaps

With uncertainty over NIH funding under the Trump administration, it's time for the biopharma industry to step in to support medical research, Chris Gibson, CEO of Recursion Pharmaceuticals, writes in a new opinion piece.

Gibson, one of the few biotech leaders who has spoken out about how of NIH policy changes could affect the the industry and U.S. leadership in biomedical research, noted that the work the agency funds helps drive industry innovation. He points, in particular, to Small Business Innovation Research (SBIR) funding that the NIH grants to startups and that is now in doubt.

While it's important to eliminate wasteful spending, he writes, "we also need to be extremely careful to wield a scalpel and not an axe so as not to damage America's significant lead in biomedical research as we do so, nor cut off the significant financial benefit to our country in the process."

gene therapy

Solid's Duchenne therapy shows early promise

Solid Biosciences said yesterday that the first three patients to receive its experimental gene therapy for Duchenne muscular dystrophy all produced high levels of microdystrophin, a miniature version of the protein broken in patients with the fatal disease.

Solid is competing against biotechs like Regenxbio and Kate Therapeutics to create a better or safer gene therapy than Sarepta' Elevidys, which was given broad approval last year amid intense debate at the FDA.

The new results are early, but seem to compare favorably to Elevidys. Read more from STAT's Jason Mast.

drug pricing

Drugmakers notch a win on 'pay-to-delay' deals

For years, drugmakers have been engaging in so-called pay-to-delay deals, in which a brand-name drugmaker settles a patent lawsuit by paying cash or transferring something else of value to a generic rival, which agrees to delay launching a copycat medicine. This gives the brand-name drugmaker more time to sell its medicine without lower-cost competition.

In 2019, California enacted a law that banned these deals, but a federal judge has just ruled that this law is unconstitutional and so cannot be enforced against agreements that had no link to the state.

Pay-to-delay deals have factored into the larger debate over the cost of prescription medicines. The FTC has gone to court several times to protest such deals, while the pharma industry argues that these deals actually allow lower-cost drugs to reach consumers faster than if patent litigation drags on for year.