By Patrick Wingrove
(Reuters) -A U.S. federal judge has sided with a U.S. regulator’s decision last year to take Eli Lilly’s blockbuster weight loss and diabetes drugs Zepbound and Mounjaro off a list of medicines in short supply, a ruling that could dash patients’ hopes of regaining access to cheaper copies of the popular therapies.
The U.S. Food and Drug Administration decision was also a blow to compounding pharmacies that had been allowed to produce hundreds of thousands of doses of copies of obesity drugs only while the FDA said there was a shortage of them.
U.S. District Judge Mark Pittman in Texas issued the order on Wednesday under seal in response to an October lawsuit from a compounding industry group against the FDA’s edict. The judge in March refused to allow compounding pharmacies to keep making copies of Zepbound and Mounjaro while the case was ongoing.
All compounding pharmacies, including larger so-called outsourcing facilities, were required to cease making copies of the drugs on March 19. They might have been able to restart production had the judge ruled the other way.
The judge last month also 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. Pittman has yet to issue a ruling in that case, which was also filed by the Outsourcing Facilities Association.
In their lawsuit against the FDA and Lilly, the compounders said the FDA relied solely on statements by Lilly in determining that there was no shortage, and that patients were still often unable to access the drugs.
Outsourcing Facilities Association Chairman Lee Rosebush said he was disappointed with the court’s decision, adding that “drug shortage determinations affect patient access to medical treatment and should be based on sound reasoning and verifiable data, not the say-so of self-interested manufacturers seeking to push competitors out of the market”.
A Lilly spokesperson said the court’s decision confirms that Mounjaro and Zepbound are not in shortage, and that “continuing to sell mass compounded products, including when referring to them as ‘personalized’, ‘tailored’ or something similar, is breaking the law”.
The FDA did not respond to a request for comment.
(Reporting by Patrick Wingrove; Editing by David Gregorio and Aurora Ellis)
