In a recent development, the Outsourcing Facilities Association has initiated legal action against the U.S. Food and Drug Administration (FDA). The lawsuit, filed on October 7, 2024, in Fort Worth, Texas, challenges the FDA's decision to remove Eli Lilly's weight loss and diabetes medications from its list of drugs in short supply.
The association argues that the FDA's action was "arbitrary, capricious and contrary to law." They claim that Eli Lilly's tirzepatide, marketed as Zepbound for weight loss and Mounjaro for diabetes, remains in short supply despite the FDA's recent decision. The group contends that the FDA failed to provide an opportunity for public input and relied solely on assurances from Eli Lilly, which they describe as "the company that is self-interested in monopolizing the market."
This legal challenge highlights the complex interplay between drug manufacturers, compounding facilities, and regulatory bodies. Compounding pharmacies have been meeting demand for these medications during shortages, a practice allowed under federal regulations when a drug is in short supply. However, if no shortage exists, federal law restricts the production of compounded versions to prevent "regular or inordinate amounts" from being made.
The FDA, established in 1906, maintains a drug shortage database to track and address medication supply issues. This list is crucial for compounding facilities, as it determines their ability to produce alternative versions of medications. The removal of Eli Lilly's products from this list could significantly impact these facilities' operations.
It's worth noting that while Eli Lilly's tirzepatide has been removed from the shortage list, the active ingredient in Novo Nordisk's similar drugs, semaglutide, remains listed. This discrepancy adds another layer of complexity to the situation.
The global market for weight loss drugs is projected to reach $100 billion by 2030, underscoring the significant economic implications of this legal battle. With obesity affecting about 42% of adults in the United States and type 2 diabetes impacting approximately 37 million Americans, the demand for these medications is substantial.
The lawsuit also raises questions about the FDA's decision-making process. The Administrative Procedure Act governs how federal agencies propose and establish regulations, and the "arbitrary and capricious" standard is often used to evaluate agency decisions in administrative law.
This case highlights the ongoing challenges in balancing public health needs, market dynamics, and regulatory oversight in the pharmaceutical industry. As the global pharmaceutical market, valued at $1.42 trillion in 2021, continues to grow, such legal challenges may become more frequent.
The outcome of this lawsuit could have far-reaching implications for the drug compounding industry, pharmaceutical companies, and patients relying on these medications. It remains to be seen how the FDA and Eli Lilly will respond to these allegations and what impact this legal action will have on the availability of these crucial weight loss and diabetes drugs.
"The FDA's action was arbitrary, capricious and contrary to law."
As this legal battle unfolds, it will undoubtedly draw attention to the complexities of drug supply management and the critical role of regulatory decisions in shaping the pharmaceutical landscape.