Four days after a compounding industry group filed a lawsuit against the FDA for removing Eli Lilly’s tirzepatide products from its shortage list, the U.S. regulator is taking a second look at its decision.
In a court filing in Fort Worth, Texas, the FDA said it would allow compounding pharmacies to continue to manufacture and sell copycat versions of Lilly’s in-demand drugs Mounjaro and Zepbound, while it reviews whether there is a shortage of the active ingredient used to make both products.
In accepting the FDA’s motion, U.S. District Judge Mark Pittman put on hold a lawsuit filed by the Outsourcing Facilities Association (OFA), which called the FDA’s decision to remove tirzepatide from the shortage list a “reckless and arbitrary decision—lacking any semblance of lawful process.”
OFA chairman Lee Rosebush applauded the FDA's move, saying the association was "greatly relieved" that its members can produce "essential copy" versions of tirzepatide while the regulator reviews its decision.
Despite the stay, the Alliance for Pharmacy Compounding has recommended to its members that they "continue to stand down on compounding tirzepatide copies," until the FDA says that it will not take enforcement action.
Two weeks ago, when Lilly informed the FDA that it could meet the skyrocketing demand for Mounjaro and Zepbound, the products were erased from the shortage list. This meant that compounders were no longer allowed to sell their knockoff versions.
In the U.S. when a drug goes on the shortage list, compounding pharmacies are allowed to produce copycats to fill the void. For decades, the production of compounded drugs has mostly been conducted on a small scale to fill existing prescriptions.
But with the outsized demand for Mounjaro and Zepbound and Novo Nordisk’s GLP-1 drugs Ozempic and Wegovy, it has become a big business, with spas and online sellers attracting customers with prices that undercut those for branded versions of the drugs.
Compounders have been able to produce tirzepatide products since the compound went on the shortage list in December of 2022. Novo’s semaglutide entered the list in August 2022 and remains in shortage. Last month, the Danish company said that it expected its shortage of Ozempic to continue through the end of the year. There are an estimated 2 million Americans taking compounded versions of the drugs, according to the Kaiser Family Foundation.
For the last two years, Lilly and Novo have battled the sellers and producers of compounded drugs, saying that their products can be unsafe as they are not subject to the regulations of their own branded drugs. The companies also have gone after sellers of compounded products who claim to provide FDA-approved treatments.
In its lawsuit, the OFA 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.”
For its part, Lilly pointed out that he FDA has declared that "Mounjaro and Zepbound are available and the shortage remains 'resolved,'" a Lilly spokesperson said in an email.
"FDA has rightly and repeatedly expressed concerns with unapproved GLP-1 drugs used for weight loss, and that such drugs are 'risky for patients, as unapproved versions do not undergo FDA’s review for safety, effectiveness and quality before they are marketed,'" Lilly said. "All doses of Lilly’s FDA-approved medicines are available and it is important that patients not be exposed to the risks in taking untested, unapproved knockoffs."
Lilly has poured billions into boosting its capacity to manufacture Mounjaro and Zepbound to relieve the shortage. Early this month, the company said it would spend $4.5 billion to build an R&D and manufacturing facility 30 miles from its headquarters in Indianapolis. That outlay comes on top of Lilly committing $9 billion to construct an active pharmaceutical ingredient plant at the same 600-acre campus that will produce Mounjaro and Zepbound.