The U.S. Food and Drug Administration (FDA) has proposed removing the active ingredients of blockbuster obesity and diabetes drugs from Novo Nordisk A/S and Eli Lilly from the list of medications that outsourcing facilities can use for bulk compounding.
If finalized, this proposal would restrict large-scale compounded production of generic versions of these drugs. Bulk compounding would be prohibited unless the specific drug is listed on the FDA's drug shortage list.
The ingredients targeted by the proposal include semaglutide, the active component in Novo Nordisk A/S's weight-loss drug Wegovy and diabetes treatment Ozempic; tirzepatide, the active ingredient in Eli Lilly's weight-loss injection Zepbound and diabetes drug Mounjaro; and liraglutide, an earlier molecule from Novo Nordisk A/S.
The FDA announced the draft rule on Thursday, suggesting the removal of these key ingredients from the bulk compounding list for outsourcing facilities.
Should the proposal be enacted, it would significantly limit the mass production of lower-cost, compounded generic alternatives. An exception for bulk compounding would only be permitted if a drug is officially listed as being in short supply.
The FDA stated it will collect public comments on the proposal until the end of June before making a final determination.
The agency noted in its announcement that there is currently no clinical necessity for outsourcing facilities to compound these drugs in bulk from bulk drug substances.
FDA Commissioner Dr. Marty Makary emphasized in a statement, "When there is an ample supply of FDA-approved, brand-name drugs, the law does not permit outsourcing facilities to compound drugs using bulk ingredients, absent a clear clinical need."
This proposal specifically targets 503B outsourcing facilities, which are regulated by the FDA and can produce large quantities of compounded drugs, with or without individual prescriptions.
The rule does not affect 503A pharmacies, which compound medications on a patient-specific prescription basis under state oversight and are not subject to this FDA regulation.
In recent years, Eli Lilly and Novo Nordisk A/S have invested billions of dollars to expand production capacity, effectively alleviating previous supply constraints. Both companies have also been working to reduce the prices of their branded drugs to retain customers who might otherwise switch to cheaper compounded alternatives.
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