An injection pen of Zepbound, Eli Lilly’s weight reduction drug, is displayed in New York Metropolis on Dec. 11, 2023.
Brendan McDermid | Reuters
The Meals and Drug Administration on Thursday stated the energetic ingredient in Eli Lilly’s weight reduction drug Zepbound is no longer in shortage, a call that can finally bar compounding pharmacies from making cheaper, unbranded variations of the injection.
“FDA has decided that the scarcity of tirzepatide injection merchandise, which first started in December 2022, is resolved,” the company stated in a letter. “FDA continues to observe provide and demand for these merchandise.”
The company’s determination, primarily based on a complete evaluation, marks the top of a interval the place sure pharmacies may make, distribute or dispense unapproved variations of tirzepatide – the energetic ingredient in Zepbound – with out dealing with repercussions for violations associated to the therapy’s scarcity standing.
Compounding pharmacies should cease making compounded variations of tirzepatide within the subsequent 60 to 90 days, relying on the kind of facility, the company stated. The FDA stated that transition interval will give sufferers time to change to the branded model.
It is a blow to some compounding pharmacies, which say their copycat medicine assist sufferers who haven’t got insurance coverage protection for Zepbound and might’t afford its hefty price ticket of roughly $1,000 a month. Zepbound and different weight reduction medicine aren’t lined by many insurance coverage, however Eli Lilly’s diabetes counterpart Mounjaro is.
It is the most recent in a high-stakes dispute between compounding pharmacies and the FDA over a scarcity of tirzepatide, the energetic ingredient in each Zepbound and Eli Lilly’s diabetes therapy Mounjaro. Eli Lilly has invested billions to develop its manufacturing capability for tirzepatide because it struggles to maintain tempo with unprecedented demand.
A commerce group representing compounding pharmacies — the Outsourcing Amenities Affiliation — sued the FDA on Oct. 8 over the company’s determination to take away tirzepatide from its official drug shortages listing simply days earlier. The group alleges the FDA acted with out correct discover, ignoring proof {that a} scarcity of tirzepatide nonetheless exists. It additionally argued that the FDA’s motion was a coup for Eli Lilly that got here on the expense of sufferers.
Following the go well with, the FDA stated it might reevaluate eradicating tirzepatide from the shortages listing. That allowed compounding pharmacies to proceed making copycats whereas the company reviewed its determination.
Compounded medicines are custom-made alternate options to branded medicine designed to satisfy a particular affected person’s wants. When a brand-name medicine is in scarcity, compounding pharmacies can put together copies of the drug in the event that they meet sure necessities below federal legislation.
The U.S. Meals and Drug Administration doesn’t evaluation the security and efficacy of compounded merchandise, and the company has urged consumers to take the authorised, branded GLP-1 medicines when they’re obtainable.
Nonetheless, the FDA does examine some outsourcing services that compound medicine, in response to its website.
Sufferers have turned to compounded variations of tirzepatide amid intermittent U.S. shortages of the branded medicine, which carry hefty value tags of $1,000 per thirty days earlier than insurance coverage and different rebates. Many well being plans do not cowl tirzepatide for weight reduction, making compounded variations a extra inexpensive different.
The energetic ingredient in Wegovy and Ozempic, semaglutide, has been in intermittent shortages over the previous two years. However the FDA earlier this month stated all doses of these medicine are actually obtainable.
The company has but to announce whether or not it’s eradicating semaglutide from its scarcity listing — a call that might probably have an effect on much more compounding pharmacies since it’s extra extensively used than tirzepatide.
Wegovy, Ozempic, Zepbound and Mounjaro are below patent safety within the U.S. and overseas, and Novo Nordisk and Eli Lilly don’t provide the energetic elements of their medicine to outdoors teams. The businesses say that raises questions about what some producers are promoting and advertising and marketing to customers.
Novo Nordisk and Eli Lilly have each stepped in to handle illicit variations of their therapies, suing weight reduction clinics, medical spas and compounding pharmacies throughout the U.S. over the previous yr. The FDA final month additionally stated it had received reports of sufferers overdosing on compounded semaglutide resulting from dosing errors corresponding to sufferers self-administering incorrect quantities of a therapy.
