FDA proposes excluding Novo, Lilly weight loss drugs from bulk compounding list in win for the companies

The headquarters of the U.S. Food and Drug Administration in Silver Spring, Maryland, Nov. 4, 2009. Jason Reed | Reuters The ⁠Food and Drug ⁠Administration on Thursday proposed ​excluding the active ingredients in Novo Nordisk ‌ and Eli Lilly 's blockbuster obesity and diabetes medications from the ⁠list ⁠of drugs that outsourcing facilities can use for ​compounding in bulk. If that proposal is finalized, the exclusion would likely limit the mass compounding — or the making of custom, often cheaper alternatives — of those medicines ​unless they appear on the FDA's ⁠drug shortage ⁠list. The agency said it will consider public comments, which can be submitted until late June, before making a final decision. The FDA finds "no clinical need" for outsourcing facilities to compound them from bulk drug substances, the agency said in a release. The proposal includes semaglutide, the active ingredient in Novo's obesity drug Wegovy and diabetes counterpart Ozempic, and tirzepatide, which is in Lilly's weight loss injection Zepbound and diabetes shot Mounjaro. It also covers ⁠Novo's older molecule liraglutide. "When FDA-approved drugs are available, ​outsourcing facilities cannot lawfully ​compound ⁠using bulk drug substances unless there is a clear clinical ⁠need," ​FDA Commissioner Marty ​Makary said in the release. …