Eli Lilly has initiated legal proceedings against two mass compounders—Strive Pharmacy LLC and Empower Clinic Services LLC—for distributing unapproved products containing tirzepatide, the primary ingredient in Lilly's weight-loss and diabetes medications. This action follows a recent federal court decision that restricts compounding pharmacies from producing copies of these drugs in the United States, except in cases where the FDA has declared a shortage.
Previously, compounders were permitted to produce these drugs due to reported shortages. However, with the FDA no longer listing these medications as scarce, large-scale compounding is now unauthorized.
Lilly asserts that Strive Pharmacy's tirzepatide products, which include additives like vitamin B12 or glycine, are falsely marketed as safer and more effective than FDA-approved treatments. Similarly, Empower Clinic Services offers compounded tirzepatide in oral and injectable forms, supplemented with vitamin B3, and allegedly misuses Lilly's clinical studies to support their efficacy claims.
The lawsuits have been filed in federal courts—against Empower in New Jersey and Strive in Delaware. Additionally, Lilly plans to issue cease and desist letters to approximately fifty other compounders and telehealth companies, demanding they halt mass compounding of these drugs and confirm their compliance.
Lilly has previously filed lawsuits against over two dozen medical spas, wellness centers, and compounding pharmacies for selling products purported to contain tirzepatide.
At OptiMantra, we can only speculate the impact that these changes will have on the availability of weight loss medications for the many medical weight loss clinics using our platform, but staying informed and adaptable will be key for clinics as they navigate continued regulatory and supply chain shifts. We'll keep you posted as soon as we hear more.
Source: Reuters
