The Outsourcing Facilities Association (OFA) has filed a lawsuit against the Food and Drug Administration (FDA) following the agency's recent decision to remove Eli Lilly's tirzepatide from its drug shortage list. The removal grants Eli Lilly exclusive rights to sell the drug, while compounding pharmacies are barred from producing it. This move has serious implications for the compounding pharmacy industry, which has been thriving on the production of compounded versions of the drug.
Compounding pharmacies threaten to breakup Big Pharma monopolies
Tirzepatide is an injection primarily used for the treatment of type 2 diabetes. It is a synthetic peptide that acts as an agonist for both the glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. This dual action helps regulate blood sugar levels by enhancing insulin secretion, reducing glucagon secretion, and promoting feelings of fullness, which can aid in weight management. Tirzepatide is marketed under the brand name Mounjaro and has gained attention not only for its effectiveness in controlling blood sugar levels but also for its potential benefits in weight loss, making it of interest to both diabetic and non-diabetic patients.
With an estimated 2 million Americans currently taking alternative forms of this drug, compounding pharmacies have seen a substantial increase in demand for their products. However, the FDA's decision last week has forced these pharmacies to cease production of tirzepatide. Previously in December 2022, the FDA designated a shortage of the drug, but the agency allowed compounding pharmacies to continue production. Eli Lilly appears to have direct influence over the FDA, because the agency is now battling compounding pharmacies on Eli Lilly’s behalf, demanding that compounding pharmacies halt production of generic forms of the drug, while Eli Lilly is allowed to continue on with production.
According to the FDA’s crony new rules, once a product is officially removed from the FDA's shortage list, small compounding pharmacies are required to halt production immediately. In contrast, larger operations, which fall under Section 503B of the Food, Drug, and Cosmetic Act, are afforded a 60-day grace period.
Since the decision, the FDA has removed both Eli Lilly’s Mounjaro and Zepbound from the shortage list. The OFA has declared this to be a “reckless and arbitrary decision” that bypassed due process. The group has accused the FDA of favoring Eli Lilly's claims that it can meet the demand for these medications, stating that the pharmaceutical giant 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,” said Lee Rosebush, chairman of the OFA, in a press release.
Lawsuit seeks to protect compounding pharmacies from FDA and Big Pharma collusion
The lawsuit, filed in U.S. District Court in Fort Worth, seeks not only the revocation of the FDA's recent action but also a temporary order to protect compounding pharmacies from enforcement actions regarding the production of tirzepatide while the case is pending. Joining the OFA in the lawsuit is North American Custom Laboratories, which operates under the name FarmaKeio Superior Custom Compounding.
Compounding pharmacies were first permitted to produce knock-off versions of Mounjaro when tirzepatide was added to the shortage list, and they subsequently compounded Zepbound in April 2023. The alternatives have gained popularity for their affordability and accessibility, particularly through online channels. However, Eli Lilly has issued cease-and-desist letters to these compounding pharmacies, as they fight for market exclusivity of the drug.
The FDA has refrained from commenting on the ongoing litigation but has previously maintained that its decisions are based on available data regarding drug availability and demand. As the legal proceedings unfold, the implications for patients relying on these compounded medications remain uncertain.
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