The FDA gave compounders a grace interval to wind down their manufacturing of the medication after the scarcity was over. Small pharmacies had till February 18 to conform, whereas bigger outsourcing services had till March 19. (Semaglutide compounders have been ordered to stop mass manufacturing this spring, with smaller compounders given a deadline of April 22 and outsourcing services given till May 22.)
While many compounding pharmacies and telehealth suppliers have halted manufacturing and gross sales, others have continued to supply tirzepatide merchandise with add-on components, unapproved dosages, or in several varieties, corresponding to oral variations. “It’s a minority,” says Jayne Hornung, chief medical officer on the pharmaceutical analytics firm MMIT.
Hornung says that corporations persevering with to promote tirzepatide are hoping the vitamin components and different tweaks will permit them to argue they aren’t promoting easy copies of Lilly’s patented medication. “They’re getting very creative,” she says.
Compounding pharmacies are typically permitted to create personalized medicines for sufferers even once they’re not in scarcity, corresponding to for people who could also be allergic to sure components or want fastidiously calibrated doses. The crux of Lilly’s argument is that, relating to tirzepatide, the drugs telehealth corporations are providing are usually not actually customized as a result of they’re being mass produced and prescribed to many sufferers.
“There are some ways that compounders tailor a medication to the patient, such as by adding another ingredient that might help with a side effect or an additional concern or diagnosis,” says Annie Lambert, a pharmacist and medical program supervisor at info companies agency Wolters Kluwer. “But there needs to be good science and evidence behind the safety of combining those things.”
Mass-producing compounded versions of existing drugs with additives was not widespread until recently, according to Nicole Snow, a pharmacist at the compounding company Olympia Pharmaceuticals, which previously produced compounded tirzepatide but stopped after the shortage ended and never included additives. “We’d seen it from time to time, but not in this magnitude,” she says. “It wasn’t a very popular thing until we got into GLP-1s.”
In its suit against Mochi, Eli Lilly claims the telehealth company “switched dosages and prescriptions for patients en masse at least five times—with corporate interests, rather than doctor decisionmaking—driving the changes.”
Those changes, Lilly alleges, included creating two new formulas containing a niacinamide additive and pyridoxine, both forms of vitamin B that the pharma company argues have not been proven to be safe or effective when combined with tirzepatide. Mochi’s own compounder, Aequita Pharmacy, made some of those products. In March, regulators in Washington state ordered production to be halted at Aequita Pharmacy, citing safety violations connected to GLP-1 medications.
In another lawsuit filed in the same California court, Lilly claims that Fella & Delilah Health switched all of its patients from a compounded tirzepatide product with no additives to a version containing untested amino acid additives late last year.
The pharmaceutical giant’s lawsuit against Henry Meds, which offers oral and injectable GLP-1 medications, accuses the company of “creating the false impression” that clinical trials have confirmed the effectiveness of its drugs, “materially omitting that no such clinical trial data exists.”
Lilly’s lawsuit against Willow Health Services alleges that the Texas-based telehealth company falsely markets some of its products, such as an oral droplet GLP-1 drug and a version of compounded tirzepatide with added niacinamide added, as “custom-prepared” for patients despite being mass-produced.
Some companies selling compounded GLP-1 meds are unlikely to stop without a fight. A compounding trade group has filed a set of lawsuits against the FDA on behalf of clients, arguing that the agency prematurely declared the GLP-1 shortages over. Whether or not their legal efforts are successful, there’s still a possibility that the drugs could once again go into shortage if demand continues to rise. As new research continues to point to additional medical uses for these drugs, that may very well happen.
“Pharmacies compound medication all the time, and there are no lawsuits about it because they’re not trying to compete with drug companies,” Lambert says. “This is so contentious because there’s so much money at stake.”
Updated 4/23/2025, 7.06 AM ET: This article was up to date to make clear the precise nature of Eli Lilly’s criticism.
https://www.wired.com/story/glp-1-compounding-fda-lawsuits/