Drug compounders sue FDA over declaration ending Wegovy shortage

Dive Brief:

• Drug compounders are suing the Food and Drug Administration again over obesity and diabetes drugs, claiming in a complaint Monday the agency’s decision to remove Novo Nordisk’s semaglutide from its shortage list will “deprive patients of a vital treatment.”
• The original shortage declaration had permitted drug compounders to supply alternative versions of semaglutide, which Novo sells as Wegovy for weight loss and Ozempic for diabetes. Monday’s lawsuit follows an earlier action against the FDA for removing Eli Lilly’s drug tirzeptatide from its shortage list, a case that is still in federal court.
• Online health company Hims & Hers, a major seller of compounded semaglutide, will begin telling customers in coming months to begin looking for “alternative options on the commercial dosing,” CEO Andrew Dudum told Wall Street analysts Monday. The company’s shares have fallen by more than one-third since the FDA’s announcement.

Dive Insight:

The FDA’s declaration set a deadline for compounders to stop offering their versions of semaglutide — April 22 or May 22, depending on which type of legal authorization they have to sell the drug.

In the complaint filed in federal court for the Northern District of Texas, the Outsourcing Facilities Association and North American Custom Laboratories claimed the decision was “arbitrary, capricious, and contrary to law” because the FDA didn’t notify compounders in advance, nor allow for public comment.

The compounders argue a shortage still exists because the FDA acknowledged that there may still be “intermittent and limited localized supply disruptions as the products move through the supply chain,” while Novo has stated that “supply constraints” may still continue. The FDA “acted to benefit special interests, raise drug prices, and deprive much of the public access to a needed medicine,” the complaint said.

Hims, which earned $225 million in revenue from compounded semaglutide and other drugs from the GLP-1 drug class in 2024, said it intends to comply with the FDA’s ruling. “We are pretty clear with regard to what the regulation states,” Dudum said. “So my expectation is most parties in markets that have been offering commercial available doses of semaglutide will seek to [stop] in the next couple of months.”

The company is expecting to earn $725 million in revenue from weight loss drugs, even without a growing contribution from semaglutide, as part of the $2.3 to $2.4 billion it expects to earn overall. It forecast profits of between $270 million and $320 million.

Among the ways Hims expects to hit that revenue target is through “personalization” of semaglutide doses, a legally permitted approach to mitigate the drug’s side effects and help people stay on the drug.

As compounders continue their fight with the FDA, both Novo and Lilly have also been pushing back with a mix of legal filings and letters to the public warning of compounded drugs’ risks.

Separately, Lilly has also been testing a new sales strategy involving a self pay program. On Tuesday, the company announced it would begin lowering prices for Zepbound doses and offer new doses through the program. The doses are offered in vials rather than the standard autoinjectors.

Lilly lowered prices for its 2.5 milligram dose from $399 a month to $349, and its 5 milligram dose from $549 to $499. The new doses of 7.5 and 10 milligrams will be offered at $499 a month at first fill and refills completed within 45 days of the previous delivery, down from the $599 and $699 previously.

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