US Proposes Restricting Weight-Loss Drug Copies

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The US Food and Drug Administration on Thursday proposed excluding active ingredients in drugs used to treat obesity and diabetes from a bulk list available to outsourcing facilities.

Doing so would further restrict such facilities from legally manufacturing copies of these drugs by “compounding.”

“When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need,” said FDA Commissioner Marty Makary in a statement.

“This action reflects our responsibility to protect patients and preserve the integrity of the drug approval process while continuing to provide a transparent, science-based pathway for public input.”

The US regulatory agency said it did not find a clinical need for outsourcing facilities to compound semaglutide, which is in Novo Nordisk’s Ozempic and Wegovy, or tirzepatide, the key ingredient in Eli Lilly’s Zepbound and Mounjaro. The proposal also includes liraglutide.

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Compounding is not the same as creating a generic drug. Generics are FDA-approved and meet requirements including therapeutic equivalence to a brand-name medication.

A compounded drug, however, is made of FDA-approved ingredients at licensed facilities, but the drug itself is not FDA-verified.

When it comes to weight-loss drugs, the US initially tolerated compounding due to high patient demand and limited availability.

But such copies have cost companies like Novo Nordisk significant revenue. They’ve also faced criticism regarding potential health risks due to issues with dosage, quality and regulatory compliance.

If the proposal is finalized, compounding the medicines would be restricted except in the case of shortages.

The FDA’s proposal is now open to public comment until June 29.

Thursday’s announcement gave a boost to pharmaceutical companies, with Novo Nordisk gaining more than six percent in morning trading. Eli Lilly, which was also buoyed by strong quarterly results, meanwhile climbed over eight percent.

AFP