GLP-1 Drugs: What's Next after FDA's Resolution of Drug Shortages

Since 2005, GLP-1 drugs such as Ozempic, Mounjaro, Wegovy, and Zepbound have been approved by the U.S. Food and Drug Administration (FDA) to treat type 2 diabetes. Now with the growing popularity of these medications to help with weight loss, GLP-1s are in high demand, resulting in shortages of these drugs. On October 2, 2024, the FDA determined the shortage of the tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been “resolved.”

Now with the tirzepatide injection shortage having been resolved and removed from the FDA’s drug shortage list, what happens next? What future is in store for compounded GLP-1 drugs?

Foley partners Nate Beaver, co-chair of the firm’s Medical Devices Area of Focus, and David Rosen, leader of the firm’s FDA Practice Group, will discuss the following as it relates to GLP-1 drugs:

• What are GLP-1 Drugs and what is a drug shortage?
• What are compounded drugs and how they’re affected by a drug shortage?
• What’s the current status of the drug shortages for semaglutide and tirzepatide?
• What happens when a drug is removed from the drug shortage list?
• What’s the effect of the ongoing litigation between FDA and the Outsourcing Facility Association (OFA)?
• What effect, if any, as a result of the new Trump Administration?