Just a few days after a compounding industry organization initiated legal action against the FDA for excluding Eli Lilly’s tirzepatide medicines from its shortage list, the U.S. regulatory body is reevaluating its decision.
In an application to the court in Fort Worth, Texas, the FDA declared it would let compounding pharmacies engage in producing and distributing generic copies of Lilly’s sought-after medications, Mounjaro and Zepbound, while it assesses the potential scarcity of the active component used in both therapies.
U.S. District Judge Mark Pittman granted the FDA’s petition, suspending a lawsuit initiated by the Outsourcing Facilities Association (OFA) in the process, which characterized the FDA’s removal of tirzepatide off the shortage list as a “reckless and arbitrary decision—devoid of any semblance of lawful process.”
OFA chairman Lee Rosebush applauded the FDA’s move, saying that the group’s members can rest easy knowing they can produce vital generic tirzepatide versions while the drug is under regulatory review.
However, until the FDA says it will not take enforcement action, the Alliance for Pharmacy Compounding has warned its members not to compound tirzepatide replicas.
When Lilly notified the FDA two weeks ago that it could satisfy the surging demand for Mounjaro and Zepbound, the drugs were removed from the shortage list. This indicated that compounders were prohibited from selling their counterfeit versions.
When a medicine is placed on the shortage list in the U.S., compounding pharmacies are permitted to manufacture replicas to address the deficiency. For decades, compounded medicine manufacture has mostly occurred on a limited scale to fulfill existing prescriptions.
However, because of the substantial popularity of Mounjaro, Zepbound, and Novo Nordisk’s GLP-1 medications Ozempic and Wegovy, it has evolved into a significant business, with resorts and online retailers enticing consumers with prices lower than those of the branded versions of the treatments.
Since December 2022, when tirzepatide was placed on the list, compounders have been producing tirzepatide products. Novo’s semaglutide was added to the list in August 2022 and continues to be in limited supply. Last month, the Danish corporation stated its anticipation that the scarcity of Ozempic would last until the year’s conclusion. According to the Kaiser Family Foundation, around 2 million Americans are using compound formulations of the drugs.
Lilly and Novo have been fighting the vendors and manufacturers of compounded pharmaceuticals for the past 2 years, claiming that their products may be dangerous since they are not governed by the rules applicable to their proprietary medications. Additionally, the companies have gone after compounded goods dealers who advertise FDA-approved medications.
Lilly has invested billions to enhance its production capacity for Mounjaro and Zepbound to compensate for the shortfall. Earlier this month, the company announced its intention to invest $4.5 billion in the construction of a research and development, as well as production facility, located 30 miles from its corporate office in Indianapolis. This expenditure is in addition to Lilly’s commitment of $9 billion to establish an active pharmaceutical ingredient facility at the same 600-acre site, which will manufacture Mounjaro and Zepbound.
