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US judge sides with FDA's removal of Lilly's weight loss drug from shortage list
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US judge sides with FDA's removal of Lilly's weight loss drug from shortage list
May 26, 2025 2:56 AM

May 7 (Reuters) - A U.S. federal judge has sided with a

U.S. regulator's decision last year to take Eli Lilly's ( LLY )

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.

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"..

The FDA and Lilly did not immediately respond to requests

for comment.

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