Washington, D.C. — Pharmaceutical giant Eli Lilly has entered the legal fray by filing a motion on January 1 to join a lawsuit challenging the U.S. Food and Drug Administration’s (FDA) decision regarding the manufacturing of generic versions of GLP-1 drugs, such as those Lilly markets under the names Mounjaro and Zepbound. The company asserts significant stakes in the ongoing legal battle over whether compounding pharmacies may continue creating generics previously necessitated by drug shortages.
The initial lawsuit was launched in October by the Outsourcing Facilities Association and FarmaKeio Custom Compounding, a Texas-based compounding pharmacy. These plaintiffs are contesting the FDA’s October decision to remove tirzepatide from its drug shortage list, which previously permitted legal production and sale of the drug by compounding pharmacies to address unmet patient needs. However, an FDA declaratory order in December reasserted the end of the shortage and implemented a 60- to 90-day wind-down period for the production of the drug by these pharmacies.
Eli Lilly’s intervention comes amidst concerns that their interests might not be fully represented by the existing parties in the lawsuit, including the FDA. The pharmaceutical company pointed out that while the FDA is expected to defend its order, the agency’s broader public policy obligations might not align perfectly with Lilly’s commercial interests. Lilly emphasizes its particular interpretation of the Food, Drug, and Cosmetic Act, which it believes prohibits the copying of commercially available drugs by compounding pharmacies, regardless of any shortage.
According to Lilly, statutory text and legislative history affirm that the commercial availability of a drug is distinctly different from its shortage status, a point which the FDA could interpret differently. This has led Lilly to worry about potential adverse outcomes that might allow pharmacies to continue producing generics based on the drug’s previous shortage status.
The Outsourcing Facilities Association and other plaintiffs argue that the FDA’s recent decision conflicts with earlier allowances letting compounding pharmacies produce generics during drug shortages. This, they claim, indicates a need to revisit and potentially revise regulatory approaches to drug compounding under sections 503A and 503B of the Food, Drug, and Cosmetic Act.
As the lawsuit progresses, the timelines set by the FDA for phasing out compounded tirzepatide are nearing an end, with state-licensed pharmacists and physicians required to cease production by February 18, and outsourcing facilities by March 19. This legal challenge thus not only seeks to contest the FDA’s decisions but also to clarify the conditions under which compounded medications can be produced going forward.
Eli Lilly’s participation underscores the broader implications of the lawsuit for pharmaceutical manufacturers, specifically concerning the balance between protecting intellectual property and ensuring drug accessibility amidst shortages. The outcome could set important precedents for the regulation of drug compounding and the role of generics in the pharmaceutical market.
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