The Outsourcing Facilities Association, representing companies producing generic versions of Eli Lilly's (LLY, Financial) weight loss drug, has filed a lawsuit against the U.S. Food and Drug Administration (FDA) in a Texas federal court. The group claims that the FDA's decision to remove Eli Lilly's drug from the shortage list was "arbitrary, capricious, and unlawful." This decision, they argue, limits patient access to crucial medications, prompting a request for the court to overturn or modify the FDA's ruling.
Eli Lilly's weight loss drug has faced shortages since 2022, leading the FDA to permit pharmacies to produce and sell cheaper, non-branded versions. However, the FDA recently stated that the shortage issue has been resolved, thus restricting the compounding of these drugs by pharmacies.
The plaintiff, including the compounding pharmacy FarmaKeio Custom Compounding, contends that the FDA should have given advanced notice and sought public input on their decision. They assert that the shortage of Eli Lilly's drug has not genuinely ended, and that the FDA's decision restricts patient access to vital treatments.
Eli Lilly has been working to improve drug supply, including building a new manufacturing facility in Indiana. Some compounding pharmacies indicated they might continue producing the drug under a federal provision that allows compounding to meet specific patient needs.
This lawsuit highlights the impact of drug shortages on patient access and raises concerns about the transparency and rationale of the FDA's decision-making process. Many patients might face higher medication costs or need to search for alternative treatments as a result of the FDA's decision.
