Pharma Pulse: The FDA Shake-Up and Growing Frustration with Prior Auth Reform

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast bringing you the latest insights shaping patient access, regulatory policy, and healthcare innovation. I’m your host, and let’s get into today’s headlines.

First up, FDA Commissioner Dr. Marty Makary resigned from his role this week, marking a notable leadership change at the agency during a period of ongoing regulatory activity across drug policy and market access. The move adds further uncertainty to FDA direction on key issues including drug oversight, access frameworks, and evolving pharmaceutical regulation. Kyle Diamantas, who previously acted as the FDA deputy commissioner for food, will serve as the agency’s acting commissioner.

Next, Eli Lilly has released new data showing that patients with obesity were able to maintain long-term weight loss after transitioning from higher-dose injectable therapies to lower-dose Zepbound or the company’s oral GLP-1 offering Foundayo.The findings add to Lilly’s broader strategy of optimizing dosing flexibility and supporting long-term persistence in obesity treatment as patients move between different therapeutic formats.

In regulatory news, the FDA proposed to exclude GLP-1 therapies—including semaglutide and tirzepatide—from the 503B bulk drug substances list. The proposal would limit large-scale compounding of these agents by outsourcing facilities, signaling a continued effort by the agency to restrict compounded GLP-1 supply outside of FDA-approved products.

And finally, physicians are continuing to voice concerns that prior authorization reform efforts are not keeping pace with expectations. According to a new American Medical Association survey, only one in three physicians agree a broad insurer pledge to reform authorization would produce meaningful changes for patients and practices. While policy discussions have emphasized reducing administrative burden, clinicians report that improvements in approval timelines and treatment access remain limited in day-to-day practice.

That's it for this episode of Pharma Pulse. For more insights on trends transforming pharmaceutical access, visit pharmaceuticalcommerce.com. Thanks for listening—until next time, stay well and stay informed.

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