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 mentioned the energetic ingredient in Eli Lilly’s weight reduction drug Zepbound is now not in scarcity, a choice that can ultimately 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 mentioned in a letter. “FDA continues to observe provide and demand for these merchandise.”
The company’s resolution, primarily based on a complete evaluation, marks the tip of a interval the place sure pharmacies may make, distribute or dispense unapproved variations of tirzepatide – the energetic ingredient in Zepbound – with out going through repercussions for violations associated to the remedy’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 mentioned. The FDA mentioned 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 medication assist sufferers who do not have insurance coverage protection for Zepbound and may’t afford its hefty price ticket of roughly $1,000 a month. Zepbound and different weight reduction medication 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 remedy Mounjaro. Eli Lilly has invested billions to increase 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 resolution 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 mentioned it could reevaluate eradicating tirzepatide from the shortages listing. That allowed compounding pharmacies to proceed making copycats whereas the company reviewed its resolution.
Compounded drugs are custom-made alternate options to branded medication 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 overview the protection and efficacy of compounded merchandise, and the company has urged shoppers to take the authorized, branded GLP-1 drugs when they’re obtainable.
Nevertheless, the FDA does examine some outsourcing amenities that compound medication, in keeping with its web site.
Sufferers have turned to compounded variations of tirzepatide amid intermittent U.S. shortages of the branded medication, which carry hefty worth 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 various.
The energetic ingredient in Wegovy and Ozempic, semaglutide, has been in intermittent shortages over the previous two years. However the FDA earlier this month mentioned all doses of these medication at the moment are obtainable.
The company has but to announce whether or not it’s eradicating semaglutide from its scarcity listing — a choice that might probably have an effect on much more compounding pharmacies since it’s extra broadly 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 substances of their medication to exterior teams. The businesses say that raises questions about what some producers are promoting and advertising and marketing to shoppers.
Novo Nordisk and Eli Lilly have each stepped in to handle illicit variations of their remedies, suing weight reduction clinics, medical spas and compounding pharmacies throughout the U.S. over the previous yr. The FDA final month additionally mentioned it had obtained reviews of sufferers overdosing on compounded semaglutide on account of dosing errors comparable to sufferers self-administering incorrect quantities of a remedy.
