The Food and Drug Administration (FDA) recently announced the resolution of the nationwide shortage of Eli Lilly’s blockbuster diabetes and weight-loss drugs, Mounjaro and Zepbound. This decision has significant implications for compounding pharmacies and online telehealth companies that have been offering lower-cost, compounded versions of these medications.
This announcement marks a victory for Eli Lilly, which had been urging the FDA to address the shortage for several months. The decision will likely impact patient access to these drugs, potentially affecting cost and availability. The FDA’s declaration that “Lilly’s supply is currently meeting or exceeding demand” after a two-year shortage, signifies a shift in the market for tirzepatide, the active ingredient in both Mounjaro (approved for diabetes) and Zepbound (approved for obesity).
The rising popularity of GLP-1 receptor agonists, a class of drugs that includes tirzepatide, stems from their remarkable effectiveness in weight loss by suppressing appetite and promoting satiety. While Mounjaro and Zepbound are no longer in shortage, other GLP-1 drugs like Novo Nordisk’s Wegovy and Ozempic remain on the FDA’s shortage list. This sustained demand fueled the growth of compounding pharmacies and telehealth platforms like Hims and Ro, which capitalized on the shortage by offering more affordable compounded versions online, often priced significantly lower than the branded medications.
The FDA’s decision mandates that these businesses phase out their compounded tirzepatide products within 60 to 90 days, depending on their size. This timeframe allows for a transition back to Lilly’s manufactured drugs, potentially enhancing consumer safety.
The FDA’s allowance of compounded medications is typically contingent on drug shortages. Compounding pharmacies, regulated primarily at the state level, formulate customized medications using raw ingredients, often catering to patients with specific allergies or needs. However, the FDA has previously issued warnings regarding quality control issues with some compounded GLP-1 drugs sold online, highlighting concerns about ingredient accuracy and formulation consistency. The proliferation of compounded GLP-1 drugs was further exacerbated by aggressive online marketing campaigns from telehealth companies, which are not subject to the same stringent advertising regulations as pharmaceutical manufacturers.
This recent decision reverses a previous FDA declaration in early October that prematurely announced the end of the Mounjaro and Zepbound shortage. That initial announcement was met with public resistance and a lawsuit from compounding pharmacies, leading to the FDA’s reconsideration and the current decision. The transition away from compounded tirzepatide products could have a substantial impact on the accessibility and affordability of these weight-loss and diabetes treatments. It also underscores the complex interplay between drug shortages, regulatory oversight, and the growing role of telehealth in the pharmaceutical landscape.
