While the regulator conducts another review into the supply of Eli Lilly’s tirzepatide, compounders will be able to continue selling their own remixed versions of the blockbuster drug.
The FDA on Friday announced that it would reconsider taking Eli Lilly’s type 2 diabetes and weight loss medication tirzepatide off its shortage list, a decision that could allow compounded versions of the drug back into the market, according to media reports.
The regulator in a court filing said that it would conduct another review to better assess the supply status of tirzepatide and more accurately determine whether the drug is indeed in shortage, according to Reuters. In the meantime, the FDA will not go after pharmacies and clinics selling compounded tirzepatide.
With its plans to conduct another supply review, the FDA has cast some doubt on its announcement earlier this month that tirzepatide was no longer in shortage. Still, the regulator cautioned at the time that patients might still have trouble refilling their prescriptions at certain pharmacies due to site-specific factors, such as logistical and retail capacity constraints.
Compounding pharmacies—entities that make and sell their own mixed version of tirzepatide—challenged the FDA’s move with a lawsuit filed last week with the U.S. District Court for the Northern District of Texas.
The Outsourcing Facilities Association, a trade group for FDA-registered compounding pharmacies, in its complaint alleged that in declaring the end of the tirzepatide shortage, the regulator made a “reckless” and in “arbitrary” decision—one that lacked “any semblance of lawful process.” The group also said the regulator’s announcement could potentially “deprive patients of a vital treatment for type 2 diabetes and obesity.”
“Compounding is the process by which a doctor, pharmacist, or licensed outsourcing facility combines, mixes, or alters ingredients to create medicines tailored the patient needs,” according to the lawsuit. When a drug is in shortage, Congress allows these entities to sell compounded drugs to meet patient needs.
Compounding helped diabetes and obesity patients to gain access to tirzepatide, the lawsuit contends. “Patient demand has been satisfied in precisely the manner Congress contemplated.”
The FDA’s announcement earlier this month that tirzepatide was no longer in shortage came “without notice, without soliciting input from affected parties and the public, and without meaningful rationale,” the group claims. “The sole factual assertion the FDA made concerning a shortage was that it persists,” according to the lawsuit, pointing to the regulators disclaimers that patients might still encounter limited tirzepatide availabilities at their pharmacies.
For its part, Lilly has taken a strong stance against compounded versions of tirzepatide. In September and October 2023, the pharma filed lawsuits against several wellness spas and clinics that sold their remixed versions of the blockbusters. The company continued its legal salvo in June 2024 when it filed another round of suits against compounders.
