FDA Proposes Ban on Compounded Obesity and Diabetes Drugs, Names New Acting Director

The U.S. Food and Drug Administration (FDA) has proposed excluding the active ingredients in widely prescribed obesity and diabetes drugs from a list of substances that can be used for compounding certain medications, according to STAT.

The agency determined there is no "clinical need" to allow large compounding facilities to produce large quantities of medicines containing semaglutide or tirzepatide. Semaglutide is the active ingredient in Novo Nordisk’s Wegovy (weight loss) and Ozempic (diabetes), while tirzepatide is the active ingredient in Eli Lilly’s Mounjaro (diabetes) and Zepbound (obesity).

This decision specifically targets compounders amid growing controversy over their role in making weight loss treatments widely available in recent years. The FDA stated that these compounders no longer meet the legal requirements to market their products, marking a significant shift in regulatory policy.

FDA Names Katherine Szarama as Acting Director of CBER

The FDA also announced the appointment of Katherine Szarama as acting director of the Center for Biologics Evaluation and Research (CBER), which oversees vaccines, gene therapies, and the blood supply. Szarama replaces Vinay Prasad, who left the agency on Thursday after a contentious tenure marked by controversial decisions on rare disease drugs and vaccines.

FDA Commissioner Marty Makary confirmed in March that Prasad would return to the University of California, San Francisco. Szarama joined the FDA at the end of last year as Prasad’s deputy and will serve in an acting capacity, though it remains unclear whether she will be appointed permanently.

Prior to this appointment, government and industry sources indicated that Houman Hemmati, an ophthalmologist, biopharma executive, and frequent Fox News contributor, was considered a top candidate for the role.

For further details, continue reading the full story on STAT+.