Drug makers can’t make knockoff weight-loss drugs anymore—and they’re mad

Compounding pharmacies are suing the Food and Drug Administration so they can keep making imitation versions of popular—and lucrative—tirzepatide drugs, namely knockoffs of Mounjaro for diabetes and Zepbound for weight loss.

Generally, compounding pharmacies make customized formulations of drugs for patients with specific needs, like when a patient has an allergy to a filler ingredient or if a child needs a liquid version of a drug that normally comes as a capsule. But larger compounding operations are also legally allowed to make imitations of branded drugs if those drugs are in short supply, acting as a stopgap for patients.

Tirzepatide has certainly been in short supply in recent years. Given the high prevalence of diabetes and obesity in America and the drug's effectiveness, demand for tirzepatide and other drugs in the new GLP-1 class have skyrocketed, and many patients have struggled to fill prescriptions. The FDA placed tirzepatide on its drug shortage list in December of 2022—and that's where it remained until last week.

On October 2, the FDA announced that the tirzepatide shortage had been resolved and that the nation's supply of GLP-1 drugs was stabilizing, though other drugs in the class, including semaglutide, remain in short supply.

"FDA confirmed with the drug’s manufacturer [Eli Lilly] that their stated product availability and manufacturing capacity can meet the present and projected national demand," the agency said in its announcement. However, it cautioned that patients and prescribers "may still see intermittent localized supply disruptions" as the drugs move through the supply chain.

End of an era

With the resolution, compounding pharmacies are no longer able to produce tirzepatide. And the FDA highlighted the point to the drug makers, writing in bold that the agency "reminds compounders of the legal restrictions on making copies of FDA-approved drugs."

In an acerbic federal lawsuit filed in Texas this week, an industry group representing large compounding pharmacies—aka outsourcing facilities—blasted the FDA for removing tirzepatide from the shortage list. The group, the Outsourcing Facilities Association, along with a Texas-based compounder, argue that the tirzepatide is still in short supply and that the FDA blindly accepted the word of Lilly—a company that is "self-interested in monopolizing the market." The compounders back up the claim by noting that the FDA warned in its announcement that "intermittent localized supply disruptions" could continue.

The compounders called the FDA's announcement "a reckless and arbitrary decision—lacking any semblance of lawful process," which would "deprive patients of a vital treatment for type 2 diabetes and obesity, two of the most common and harmful medical conditions in existence."

The compounders also claimed that the FDA broke administrative law by not allowing a public comment or notice period, not providing evidence of sufficient supply, not explaining its decision-making process, and not publishing its decision in the Federal Register.

The FDA does not comment on ongoing litigation. However, in its guidance for compounding pharmacies, the FDA says it "recognizes there may be circumstances where an outsourcing facility may not be able to predict when a drug shortage will be resolved." The agency gives compounders 60 days to wrap up drug orders received before the shortage ended. But the FDA may take enforcement action after the 60 days or if a compounder continues to fill new orders.

The agency has also made a point to caution consumers that compounded GLP-1 drugs are not approved by the FDA and have not been reviewed for safety, efficacy, or quality. In July, the agency warned of reports that people were overdosing on off-brand GLP-1 drugs due to poor labeling and packaging.