FDA proposes excluding Novo, Lilly weight loss drugs from bulk compounding list in win for the companies
The FDA proposed excluding the active ingredients in Novo Nordisk and Eli Lilly's obesity and diabetes drugs from the list of substances that 503B outsourcing facilities can use for bulk compounding, which could limit the production of cheaper, compounded versions of these medications. The agency cited no clinical need for compounding these drugs when FDA-approved versions are available and will accept public comments before finalizing the decision. The move supports Novo and Lilly by protecting their branded products, though it does not affect 503A pharmacies that compound drugs for individual patients.
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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.
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