With an estimated 2 million people in the United States taking copycat versions of Eli Lilly and Novo Nordisk’s incretin hormone drugs, compounding pharmacies have suddenly thrived from their ability to help meet the booming demand for these products.
But last week, when the FDA removed Lilly’s tirzepatide from its drug shortage list, it erased the compounders’ qualification to manufacture one of their two new cash cows.
In response, a compounding industry group has sued the FDA, claiming its action to remove Lilly’s Mounjaro and Zepbound from the shortage list is a “reckless and arbitrary decision—lacking any semblance of lawful process.”
In U.S. District Court in Fort Worth, Texas, the Outsourcing Facilities Association (OFA) has alleged (PDF) that the FDA’s action was contrary to law and that it should be immediately revoked. The OFA also is seeking a temporary order that would prevent the FDA from taking action against its members for making compounded versions of tirzepatide until the lawsuit is resolved.
The suit criticizes the agency for not soliciting public comment on the move and for taking the word of Lilly that it can meet the demand for the products. The suit said that Lilly “is self-interested in monopolizing the market.”
“The agency’s decision will have tremendous implications across the nation for patients and physicians, as well as the outsourcing facilities that made an enormous investment to meet patient demand in light of product shortages and delays," Lee Rosebush, the chairman of the OFA, said in a release.
The FDA said that it does not comment on ongoing litigation.
Compounding pharmacies were first allowed to manufacture knock-off versions of diabetes drug Mounjaro when the FDA listed tirzepatide on its shortage page in December of 2022. Then in April of this year, the regulator added obesity drug Zepbound to the list. The copycats have been cheaper and easy to access, particularly online, and have surged in popularity as demand for the treatments has skyrocketed.
Once a product has been removed from the FDA shortage list, small compounding pharmacies must stop production immediately while larger compounders—which operate under section 503B of the Food, Drug and Cosmetic Act—have a 60-day grace period.
Compounders will still be allowed to manufacture copycat versions of Novo Nordisk’s semaglutide, which has been on the shortage list since August 2022. Last month, the Danish company said that it expected its shortage of diabetes blockbuster Ozempic to continue through the end of the year.
Joining the Outsourcing Facilities Association in filing the complaint is the North American Custom Laboratories, which also does business as FarmaKeio Superior Custom Compounding. In March 2022, the FDA issued a recall of products from the company that were intended to be sterile. Later in the year, the regulator also flagged the company for failing to provide evidence that it had addressed the problems that triggered the recall.