FDA Commissioner Marty Makary Resigns Amid Leadership Controversy; Eli Lilly Weight Loss Drug Trial Results Released

FDA Commissioner Marty Makary Resigns Following Internal Review

Marty Makary, Commissioner of the U.S. Food and Drug Administration (FDA), has announced his resignation from the role, effective immediately. Kyle Diamantas, the agency’s top food regulator, will serve as acting commissioner while a permanent replacement is sought, according to STAT.

A group within the U.S. Department of Health and Human Services had been investigating Makary’s leadership for months, citing dissatisfaction with his management approach. Makary’s tenure was marked by both ambitious regulatory initiatives and significant challenges, including personnel turnover, internal disputes, and allegations of political interference undermining the FDA’s scientific integrity.

During his time as commissioner, Makary spearheaded numerous initiatives, such as:

• Shortening drug review timelines to accelerate approvals;
• Cracking down on misleading advertising in the pharmaceutical industry;
• Pressuring the food industry to eliminate chemical dyes from products.

However, his leadership was also characterized by turmoil, including the departure of long-serving staff and ongoing controversies surrounding the influence of political pressures on regulatory decisions.

Eli Lilly’s Weight Loss Drug Trial Reveals Mixed Results for Foundayo

Eli Lilly has released partial results from a late-stage clinical trial evaluating its oral weight loss medication, Foundayo (orforglipron), compared to injectable alternatives. The findings were presented at an obesity conference and reported by Reuters.

Key findings from the trial include:

• Patients who switched from Novo Nordisk’s injectable Wegovy to Lilly’s oral Foundayo regained an average of 2 pounds after one year;
• Those who switched from Lilly’s more potent injectable Zepbound to Foundayo regained an average of 11 pounds over the same period.

The study examined patients who had previously lost weight using either Lilly’s tirzepatide (sold as Zepbound and Mounjaro) or Novo Nordisk’s injectable semaglutide (marketed as Wegovy and Ozempic). After 72 weeks of treatment with these injectable medications, participants were transitioned to Foundayo to assess weight maintenance.

For more details on the trial and its implications for the weight loss drug market, continue reading at STAT+.