A federal judge has effectively ended the ability of compounding pharmacies to make their own copies of Eli Lilly’s weight loss and diabetes drugs Zepbound and Mounjaro.
In a sealed decision filed late Wednesday, Judge Mark Pittman of the Northern District of Texas declined to issue an injunction to stop the Food and Drug Administration (FDA) from declaring there was no longer a shortage of the medicines’ active ingredient, tirzepatide.
The lawsuit against FDA was brought in October by a trade organization representing compounding industry groups. The Outsourcing Facilities Association (OFA) alleged the agency was “abruptly depriving patients of much needed treatment and artificially raising drug prices.”
Compounders had been allowed to produce and sell hundreds of thousands of their own versions of popular anti-obesity drugs, so long as the FDA considered them in shortage.
Compounded drugs are sold at vastly lower prices than the branded versions, but drug companies and some obesity specialists have expressed concerns that some compounded products aren’t FDA-approved.
After the suit was filed, the FDA temporarily paused to reconsider the declaration to end the shortage but ultimately reaffirmed its decision in December. The agency said it would not take any enforcement action against compounders before the court ruled.
The agency at the time gave drug compounders a transition period to avoid patient care disruption. Smaller state-licensed pharmacies had until Feb. 18 and now must immediately stop producing their own copies of the drugs.
Larger outsourcing facilities, which are FDA-regulated and can create prescription-specific compounded drugs as well as bulk orders, must cease compounding, distributing or dispensing tirzepatide injections by March 19.
OFA’s lawsuit said FDA made its decision to remove tirzepatide from the shortage list based only on statements from the manufacturer, “without notice, without soliciting input from affected parties and the public, and without meaningful rationale.”
In a statement to The Hill on Thursday, OFA Chair Lee Rosebush said the group “is considering all of its options regarding the judgment, including an appeal.”
Rosebush said he couldn’t comment on specifics of the decision until the court unseals it.
Eli Lilly in a statement said the decision “marks the end of the road for mass compounding of risky, unapproved knockoffs that threaten the health and safety of Americans.”
Any company that continues mass compounding tirzepatide “is breaking the law, and we will work with regulators and law enforcement to stop it,” a company spokesperson said.
A similar OFA lawsuit against FDA for removing semaglutide, the active ingredient in Ozempic, from the shortage list is pending.
