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.