FDA Declares End to Wegovy and Ozempic Shortage
February 21, 2023: The U.S. Food and Drug Administration (FDA) has declared an end to the shortage of Novo Nordisk’s popular weight-loss and diabetes drugs, Wegovy and Ozempic. This announcement marks a significant shift in the market for these medications and will restrict the widespread sale of cheaper copies produced by compounding pharmacies.
Impact on Hims & Hers Health
The FDA’s declaration has had a significant impact on Hims & Hers Health, a company that has heavily marketed its compounded versions of weight-loss drugs, including semaglutide, the active ingredient in Wegovy and Ozempic. Hims & Hers shares plunged 22% following the FDA’s announcement, reflecting concerns about the loss of market share for its compounded products.
Background: Compounding Pharmacy and Drug Shortages
Under U.S. regulations, compounding pharmacies are permitted to replicate brand-name medications that are in short supply. Wegovy and Ozempic experienced shortages for much of 2022, leading to increased demand for compounded versions. These compounded medications are often cheaper than brand-name products and can be obtained without a prescription from a telehealth provider.
FDA’s Decision and Grace Period
With the FDA’s declaration of an end to the shortage, the grace period for compounding pharmacies to continue producing compounded versions of Wegovy and Ozempic has begun. This grace period typically lasts 60-90 days, giving pharmacies time to transition patients to FDA-approved versions.
Implications for Compounding Pharmacies
Industry analysts believe that the FDA’s announcement will initiate a new era for the market access of Novo Nordisk’s drugs. Compounding pharmacies will no longer have unfettered access to these medications, and the sale of compounded versions of Eli Lilly’s rival obesity and diabetes drugs, Zepbound and Mounjaro, has already been banned by the FDA.
Transition Concerns and Patient Impact
The Alliance for Pharmacy Compounding has expressed concerns about whether the FDA considered the number of patients who will need to transition from compounded drugs to FDA-approved versions. The Alliance estimates that over 200,000 prescriptions for compounded semaglutide drugs were being filled each month, highlighting the potential impact on patients.
Novo Nordisk’s Statement
Novo Nordisk has welcomed the FDA’s assessment, stating that the U.S. supply of Wegovy and Ozempic now meets or exceeds current and projected demand. The Danish drugmaker has invested billions to increase production of these treatments.
Market Reaction and Availability
Shares of Novo Nordisk rose 6.2% on the New York Stock Exchange following the FDA’s announcement. All doses of Ozempic and Wegovy are now listed as available on the FDA’s website.
Conclusion
The FDA’s declaration of an end to the Wegovy and Ozempic shortage is a significant development that will reshape the market for these medications. While the grace period provides some time for compounding pharmacies to transition, it marks a potential end to the sale of unauthorized copies of these popular drugs.
