In a major legal victory for Novo Nordisk, a Texas federal judge ruled to restrict compounding pharmacies from producing and selling cheaper, unapproved versions of the pharmaceutical giant’s blockbuster drugs, Wegovy and Ozempic. This ruling comes after a legal challenge initiated by a compounding trade group regarding the FDA’s decision that the active ingredient in these drugs, semaglutide, is no longer in shortage in the U.S.
Legal Ruling on Semaglutide Shortage
The ruling came late Thursday when U.S. District Judge Mark Pittman denied the request from the Outsourcing Facilities Association (OFA) for a preliminary injunction. This decision prevents compounding pharmacies from continuing to make copies of semaglutide while a legal challenge over the drug shortage is ongoing. The judge’s decision upholds the FDA’s previous stance that the shortage of semaglutide has ended, allowing the agency to now enforce stricter regulations on compounded versions of the drug.
Impact of the Ruling on Compounding Pharmacies
Patients flocked to compounded versions of Ozempic and Wegovy during the shortages of these drugs over the past two years, particularly those who faced high drug prices or lacked insurance coverage. These compounded drugs, which are essentially custom-made copies prescribed to meet specific patient needs, have been marketed by telehealth companies such as Hims & Hers. However, both drugmakers and health experts have voiced concerns over these unapproved drugs, as the FDA does not officially approve compounded medications.
FDA to Crack Down on 503A and 503B Pharmacies
The judge’s decision also clears the way for the FDA to take immediate action against 503A pharmacies (which make compounded drugs for individual prescriptions) and 503B pharmacies (which manufacture drugs in bulk). The FDA can now begin targeting these pharmacies for non-compliance, with actions that could include product seizures and warning letters, particularly from May 22 onward.
Ongoing Legal Challenges and Industry Impact
Prior to this ruling, Novo Nordisk scored another victory when a different Texas judge permanently prohibited MediOak Pharmacy, a 503A pharmacy, from marketing or selling compounded semaglutide. Novo Nordisk has filed over 100 lawsuits against compounding pharmacies across 32 states in a push to protect consumers from unregulated semaglutide products.
The ruling against compounding pharmacies also mirrors legal battles fought by Eli Lilly over its diabetes and weight loss drugs, Mounjaro and Zepbound. The FDA declared the shortage of tirzepatide, the active ingredient in these drugs, to be over in 2023. As a result, a compounding trade group has filed a lawsuit against the FDA, though a federal judge in March denied the group’s request for an injunction against the FDA’s enforcement.
Outlook
As both Novo Nordisk and Eli Lilly continue their legal efforts to prevent the sale of compounded versions of their drugs, the court rulings mark a significant step toward protecting the integrity of their treatments. These companies are working to ensure that patients only have access to FDA-approved medications, aiming to safeguard patient safety and maintain the value of their branded products.