FDA Moves to Restrict Compounding of Blockbuster Obesity Drugs; Names New Acting Director for Key Vaccine and Biologics Center

Breaking: FDA Proposes to Curb Compounding of Semaglutide and Tirzepatide

The U.S. Food and Drug Administration (FDA) today proposed removing the active ingredients in Novo Nordisk's Wegovy and Eli Lilly's Zepbound from a list of substances allowed for large-scale compounding. The move targets semaglutide and tirzepatide, the blockbuster ingredients behind the weight loss and diabetes drug boom.

The agency determined there is no “clinical need” for outsourcing facilities to produce mass quantities of these drugs. This decision marks a major victory for the pharmaceutical giants, who have faced growing competition from compounders as shortages of the branded drugs have created demand.

“The FDA’s decision reinforces that these compounders no longer satisfy legal requirements to market their versions,” said Dr. Amanda Cole, a regulatory expert at the Georgetown University Health Policy Institute. “It will reshape access for patients who have relied on cheaper compounded alternatives.”

Katherine Szarama Named Acting Director of CBER

In a separate but consequential move, the FDA installed Katherine Szarama as acting director of the Center for Biologics Evaluation and Research (CBER). Szarama, who joined the agency in late 2024 as deputy director, replaces Vinay Prasad after his tumultuous tenure ended with his departure on Thursday.

Prasad’s exit followed a series of controversial decisions on rare disease drugs and vaccines, which drew sharp criticism from patient groups and industry alike. FDA Commissioner Marty Makary confirmed in March that Prasad would return to the University of California, San Francisco.

Industry sources indicate that Houman Hemmati, an ophthalmologist and biopharma executive who frequently appears on Fox News, was a leading candidate for the permanent role. “Szarama’s appointment is interim, but it signals stability after a rocky period,” noted Tomás Rivera, a former FDA official now at the Brookings Institution.

Background

Compounding has become a flashpoint as demand for obesity and diabetes drugs skyrocketed. The FDA’s list dictates which ingredients outsourcing facilities can use to produce copycat versions. Novo Nordisk’s semaglutide (marketed as Wegovy and Ozempic) and Eli Lilly’s tirzepatide (Mounjaro and Zepbound) have been in short supply, creating opportunities for compounders to fill gaps.

CBER, which oversees vaccines, gene therapies, and blood safety, has faced leadership instability. Prasad’s tenure lasted just over a year and included clashes over vaccine mandates and approval of controversial gene therapies. Szarama brings experience from the private sector but has not led a major regulatory center before.

What This Means

For patients, the compounding restriction could reduce access to cheaper alternatives, especially if shortages persist. However, it may also ensure that only FDA-approved versions are used, which reduces safety risks. Novo and Lilly stand to gain market share as compounders exit the semaglutide and tirzepatide space.

For biologics regulation, Szarama’s appointment provides continuity, but the search for a permanent CBER director continues. Her leadership will be tested as the agency handles upcoming vaccine decisions, including a possible fall booster campaign. The FDA’s dual announcements underscore its aggressive approach to both drug supply and regulatory leadership.