FDA Ends Semaglutide Shortage Listing, Contributing to Ongoing Legal Challenges

The FDA announced that the shortage of semaglutide (Wegovy, Ozempic; Novo Nordisk) is resolved and now meets or exceeds both current and projected US demands.¹ The FDA’s assessment confirms the ends of the nearly 3-year shortage that began in early 2022 due to high demand of the glucagon-like peptide-1s (GLP-1).²

Hand holding Ozempic Insulin injection pen for diabetics | Image credit: © Natalia - stock.adobe.com

"We are pleased the FDA has declared that supply of the only real, FDA-approved semaglutide medicines is resolved, affirming that Novo Nordisk is meeting or exceeding current and projected nationwide demand. No one should have to compromise their health due to misinformation and reach for fake or illegitimate knockoff drugs that pose significant safety risks to patients," Dave Moore, executive vice president, U.S. operations and global business development, and president of Novo Nordisk Inc, said in a news release.¹

Wegovy was approved by the FDA in June 2021 to treat chronic weight management in adults with obesity and overweight with at least one weight-related condition.³ While Ozempic is indicated for type 2 diabetes, it is often prescribed off-label for weight loss.² The surge in demand for semaglutide resulted in a 442% increase in fills between January 2021 and December 2023, according to data published in JAMA Health Forum.^2,4

The rising demand for GLP-1 receptor agonists led to a widespread shortage in pharmacies, impacting patients with type 2 diabetes. As the pharmaceutical supply chain struggled to match the rapid increase in demand, patients faced inflated prices or had to resort to secondary markets.⁵

"Patient safety remains our top priority and, in line with our purpose to improve lives and health, we continue to partner, educate, and advocate for expanded, affordable access to our medicines for those who need and rely on them,” Moore said in a news release.¹

Despite the seemingly positive removal of Ozempic and Wegovy from the FDA’s drug shortage list, the Outsourcing Facilities Association (OFA) with the US District Court for the Northern District of Texas sued the FDA prior to the declaration. The drug compounders claim that the decision was “reckless and arbitrary.’” The trade group is requesting the court to affirm FDA’s actions as unlawful, remove the declaration, and prevent the regulators from acting against the association’s members for compounding semaglutide.⁶

This lawsuit is not the first against the FDA from OFA as the drug compounders filed a similar lawsuit in October 2024 following the announcement of the resolved shortage of tirzepatide (Mounjaro, Zepbound; Eli Lilly). OFA claimed that there was still a shortage of tirzepatide, and patients were unable to readily obtain it. This caused the FDA to reconsider its decision to remove the drug from the official drug shortage list.^6,7

While the semaglutide injections were removed from the FDA drug shortage list, they may not be readily available, and pharmacies could still experience localized availability issues. However, patients could expect an easier process when filling a semaglutide prescription now that the shortage has been resolved.²

REFERENCES

1. FDA declares Wegovy® and Ozempic® shortage is over and that Novo Nordisk is fully meeting or exceeding nationwide demand for all doses. PR Newswire. News release. Published February 21, 2025. Accessed February 27, 2025. https://www.prnewswire.com/news-releases/fda-declares-wegovy-and-ozempic-shortage-is-over-and-that-novo-nordisk-is-fully-meeting-or-exceeding-nationwide-demand-for-all-doses-302382370.html

2 Is Semaglutide in Shortage? The Latest on Ozempic and Wegovy Availability. GoodRx. News release. Updated February 24, 2025. Accessed February 27, 2025. https://www.goodrx.com/classes/glp-1-agonists/semaglutide-shortage

3. FDA Approves New Drug Treatment for Chronic Weight Management, First Since 2014. FDA. News release. Published June 4, 2021. Accessed February 27, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-chronic-weight-management-first-2014#:~:text=For%20Immediate%20Release:%20June%2004,obesity%20or%20overweight%20since%202014.

4. Prescription Fills for Semaglutide Products by Payment Method. JAMA Health Forum. News release. Published August 2, 2024. Accessed February 27, 2025. https://jamanetwork.com/journals/jama-health-forum/fullarticle/2821688

5. Volynsky S. Rising Demand for GLP-1 Receptor Agonists Means an Increase in Patient Questions. Pharmacy Times. Published February 17, 2025. Accessed February 27, 2025. https://www.pharmacytimes.com/view/rising-demand-for-glp-1-receptor-agonists-means-an-increase-in-patient-questions

6. Compounders Sue FDA for Declaring Ozempic, Wegovy Shortage Over. BioSpace. News release. Published February 25, 2025. Accessed February 27, 2025. https://www.biospace.com/policy/compounders-sue-fda-for-declaring-ozempic-wegovy-shortage-over

7. Milenkovich N. Because Ned Said: FDA Is Sued Over Removal of Blockbuster Weight Loss Drug From Shortages List. Pharmacy Times. Published January 1. 2025. Accessed February 27, 2025. https://www.pharmacytimes.com/view/because-ned-said-fda-is-sued-over-removal-of-blockbuster-weight-loss-drug-from-shortages-list