The U.S. Food and Drug Administration (FDA) has taken two significant actions this week that will reshape the landscape for obesity treatments and the regulation of biological products. In one move, the agency proposed excluding the active ingredients of blockbuster weight loss and diabetes drugs from a list that allows large-scale compounding. In another, it named a new acting director for its Center for Biologics Evaluation and Research (CBER), signaling a potential shift in policymaking for vaccines and gene therapies. Here's a closer look at these developments.
FDA Proposes Excluding Key Obesity Drug Ingredients from Compounding List
The FDA has proposed removing semaglutide and tirzepatide from the list of substances that can be used to make compounded versions of medications by large outsourcing facilities. Semaglutide is the active ingredient in Novo Nordisk’s Wegovy (weight loss) and Ozempic (diabetes), while tirzepatide is found in Eli Lilly’s Mounjaro (diabetes) and Zepbound (weight loss). The agency determined there is no “clinical need” for these compounded versions, a decision that marks a victory for the two pharmaceutical giants and will alter consumer choices.
Over the past few years, compounding pharmacies have played an increasing role in making these popular treatments available, especially during shortages. However, the FDA now argues that the legal requirements for marketing these compounded products are no longer met. The proposal specifically targets large-scale compounders that produce medications in bulk, not individual prescriptions made by doctors for specific patients.
Why This Matters
Compounded drugs are often cheaper than brand-name counterparts, but they lack the same regulatory oversight for safety and efficacy. The FDA’s decision aims to protect patients from potential risks while ensuring that the brand-name manufacturers maintain control over their products. For Novo Nordisk and Lilly, this move could safeguard their market share, but for consumers, it may mean higher costs and fewer alternatives.
- Semaglutide – active in Wegovy and Ozempic
- Tirzepatide – active in Mounjaro and Zepbound
- Compounding facilities that produce large quantities will be affected
The FDA’s proposal is open for public comment before finalization. The agency emphasized that this does not apply to traditional compounding done in response to a specific patient’s prescription.
New Leadership at CBER: Katherine Szarama Takes the Helm
On the regulatory front, the FDA has appointed Katherine Szarama as the acting director of the Center for Biologics Evaluation and Research (CBER), the division responsible for overseeing vaccines, gene therapies, and the blood supply. She replaces Vinay Prasad, who left the agency on Thursday following a tenure marked by controversial decisions on rare disease drugs and vaccines.
FDA Commissioner Marty Makary had announced in March that Prasad would return to the University of California, San Francisco. Prasad’s departure was not unexpected, given the friction his stances caused within the agency and the broader medical community.
Szarama’s Background
Szarama joined the FDA at the end of last year to serve as Prasad’s deputy. Prior to that, she worked in various regulatory and research roles, though her specific background in biologics is not widely detailed. It remains unclear whether she will serve permanently in the role. Government and industry sources previously identified Houman Hemmati, an ophthalmologist, biopharma executive, and frequent Fox News contributor, as a top candidate for the permanent position.
- Katherine Szarama – acting director, started December 2023
- Vinay Prasad – former director, left after controversial tenure
- Houman Hemmati – potential permanent candidate
CBER oversees critical products, from COVID-19 vaccines to gene-editing therapies, so the leadership transition carries high stakes. Industry observers will watch to see whether Szarama maintains a steady course or introduces new regulatory approaches.
These two FDA actions highlight the agency’s ongoing efforts to balance innovation, access, and safety. For patients and healthcare providers, the implications will unfold in the coming months as the compounding rule is finalized and as CBER’s new leadership finds its footing.