FDA Announces Relief for Compounders as Ozempic Supply Improves
The U.S. FDA announced on Friday that it would not penalize makers of compounded versions of Novo Nordisk’s (NVO) weight loss drug Ozempic or its obesity treatment counterpart, as supply conditions for the GLP-1 drugs improve. This decision follows the official end of a long-standing shortage.
- End of National Shortage of GLP-1 Drugs
The FDA confirmed that the nationwide shortage of semaglutide, the active ingredient in Ozempic, has been resolved after nearly three years. The agency noted that manufacturers can now meet both the current and future demand for these popular medications. - FDA’s Confirmation on Supply Availability
“The FDA confirmed with the drug’s manufacturer that their stated product availability and manufacturing capacity can meet the present and projected national demand,” the regulator stated in its announcement.
Impact on Compounded Versions of Semaglutide
As the supply of Ozempic stabilizes, Hims & Hers (NYSE:HIMS), which had been producing compounded versions of semaglutide during the shortage, saw a significant drop in its market value. The telehealth company now faces restrictions and will be unable to continue its compounded drug production.
- Financial Losses for Hims & Hers
The company lost billions of dollars in market capitalization following the FDA’s decision, reflecting the impact of the end to the shortage.
FDA’s Warning on Potential Supply Disruptions
Despite the end of the shortage, the FDA warned that there may still be temporary disruptions in the local supply of semaglutide as the product moves through manufacturing and distribution channels.
- No Penalty for Compounders During Transition
To avoid unnecessary disruption in patient treatment, the FDA stated that it does not plan to take action against compounders for violations related to semaglutide, as it had been on the FDA’s drug shortage list.
The FDA’s decision aims to balance the return to normal supply with the ongoing needs of patients, offering a transition period for those who relied on compounded versions of the medication during the shortage.
