By Patrick Wingrove and Dan Levine
(Reuters) -A U.S. judge on Thursday rejected a bid by compounding pharmacies to keep making copies of Novo Nordisk’s popular diabetes and weight-loss drugs Ozempic and Wegovy while a legal challenge over drug shortages unfolds, court records showed.
The decision came in response to a February lawsuit from a compounding industry group against the U.S. Food and Drug Administration’s decision that there was no longer a shortage of the medicines’ active ingredient, semaglutide.
Compounders copy brand-name medicines that are in short supply by combining, mixing or altering drug ingredients to meet demand.
They had been allowed to produce hundreds of thousands of doses of copies of Novo’s obesity and diabetes drugs only while the FDA said they were in short supply. Many of these are sold by large telehealth companies like Hims & Hers.
U.S. District Judge Mark Pittman in Texas denied compounders’ bid for a preliminary injunction, according to the court docket. Pittman filed his legal reasoning under seal, but by denying the injunction request, a May timeline set by the FDA for when large U.S. compounders will have to exit the market remains in place.
It also follows a decision the judge made earlier this year refusing to allow compounding pharmacies to keep making copies of Eli Lilly’s weight-loss and diabetes drugs Zepbound and Mounjaro.
The FDA and Novo Nordisk did not immediately respond to requests for comment. In a previous court filing, Novo defended the FDA’s decision, saying the agency had concluded that the company’s drug supply outweighed any reasonable measure of projected demand.
Lee Rosebush, chairman of lead plaintiff Outsourcing Facilities Association, told Reuters that his organization had presented evidence of an ongoing semaglutide shortage that was obtained after the lawsuit was filed. However, Rosebush said the judge declined to consider it.
“We are obviously disappointed with this initial decision and believe the data shows that there is still a shortage of these products,” he said.
The FDA had said it would not take any enforcement action against compounders before the court ruled.
The regulator has given larger so-called outsourcing facilities, which make compounded drugs in bulk and are regulated by the agency, until May 22. Smaller compounding pharmacies, which make drugs to fill prescriptions for individual patients and are primarily overseen by U.S. states, must immediately cease making copies of semaglutide.
(Reporting by Patrick Wingrove and Dan Levine; Editing by Daniel Wallis and Christopher Cushing)
