The headquarters of the United States Food and Drug Administration in Silver Spring, Maryland, November 4, 2009.
Jason Reed | Reuters
The Food and Drug Administration proposed Thursday to exclude active ingredients from Novo NordiskAnd Elie LillyBlockbuster Obesity and Diabetes Drugs List of Drugs Outsourcing Facilities Can Use for Bulk Compounding.
If this proposal is finalized, the exclusion would likely limit the mass preparation — or creation of personalized, often cheaper alternatives — of these drugs unless they appear on the FDA’s drug shortage list. The agency said it will review public comments, which can be submitted until the end of June, before making a final decision.
The FDA sees “no clinical need” to outsource facilities to manufacture them from bulk drug substances, the agency said in a statement.
The proposal includes semaglutide, the active ingredient in Novo’s obesity drug Wegovy and its diabetes counterpart Ozempic, and tirzepatide, which is present in Lilly’s weight loss injection Zepbound and diabetes vaccine Mounjaro. It also covers Novo’s older molecule, liraglutide.
“When FDA-approved drugs are available, outsourcing facilities cannot legally use drug substances in bulk unless there is a clear clinical need,” FDA Commissioner Marty Makary said in the release.
The agency’s proposal specifically targets 503B contracting facilities, which manufacture bulk compounded drugs with or without a prescription and are largely regulated by FDA guidance.
The proposal does not impact 503A pharmacies, which manufacture compounded medications according to individual prescriptions for a specific patient and are largely regulated by states rather than the FDA.
Lilly and Novo have invested billions to increase their manufacturing capacity in recent years, which has helped ease supply constraints. The companies also continued efforts to make their branded drugs more affordable to win over users who had flocked to cheaper compounded drugs.