TWO NEW POWER SEATS ARE COMING TO THE FDA: AI AND DRUGS

🚨 Two new deputy commissioner roles are being planned at the FDA, one of them dedicated to technology and AI.

CNBC reports that HHS intends to create the positions, according to two sources familiar with the plan. The second is a deputy commissioner for drugs. No final decisions or formal announcements have been made.

The technology role would sit on both sides of the AI question: overseeing the FDA's own internal use of the tech, and its review of AI-enabled medical products. The agency already leans on a generative AI tool called Elsa for document summarization and drafting, and last week released a discussion paper on how it might regulate generative AI-enabled devices.

Jared Seehafer is the leading candidate for that job, three people told CNBC. He co-founded compliance software company Enzyme, later served as its CEO, and worked at a San Francisco venture capital firm before becoming an FDA advisor last August. CNBC could not learn of any candidates for the drugs role.

Both would report to Heidi Overton, Trump's pick for FDA commissioner, who still needs Senate confirmation. Some in the administration view the appointments as a bid for greater influence over the agency, per CNBC's sources.

The backdrop is messy. A multistate cyclospora outbreak linked to iceberg lettuce. A three-month review extension for Capricor's Duchenne drug after an advisory committee voted 9-3 against it. An accelerated approval for Replimune's melanoma drug after two prior rejections.

For biotech investors, who runs the drugs desk is the whole ballgame.

📈 Should a software founder be setting AI rules for medical devices?

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