On June 20, 2024, drug manufacturer Eli Lilly filed a number of lawsuits against compounding pharmacies and medical spas alleging that these companies have falsely claimed that they stock and sell weight loss medications with the active ingredient tirzepatide that are manufactured by Eli Lilly. These lawsuits, filed in Colorado, District of Columbia, Florida, Ohio, Texas and Washington, all claim that these entities are compounding counterfeit medications in which tirzepatide is an active ingredient, but which have not undergone required testing by the U.S. Food and Drug Administration (FDA), the sole governmental agency responsible for the approval of prescription medications.
Under federal law, compounded medications are not required to undergo clinical trials in the same manner as traditional prescription medications nor receive approval by the FDA prior to being compounded and dispensed to patients. However, the use of nonpharmaceutical grade active pharmaceutical ingredients in compounded medications, or compound medications that are not produced in an FDA-registered establishment, is prohibited by law.
With the recent rise in popularity of prescription weight loss drugs, there has been increased focus by federal and state governmental entities on pharmacies and other entities purporting to offer compounded medications with active ingredients, such as tirzepatide, intended for targeting Type 2 diabetes and obesity. For example, in February 2024, the FDA issued a warning letter to U.S. Chem Labs stating that its advertising of tirzepatide-based medications, as described on its website, constitutes "unapproved new drugs introduced or delivered for introduction into interstate commerce" in violation of the Food, Drug and Cosmetic Act. That same month, FDA issued an identical warning letter to Synthetix Inc. alleging that its tirzepatide products are also misbranded under the Food, Drug and Cosmetic Act "in that their labeling fails to bear adequate direction for their intended use(s)."
Similarly, numerous state boards of pharmacy have issued warnings to both pharmacies and consumers as to the risks of compounding medications including GLP1 hormones (the hormones that stimulate the pancreas to secret insulin associated with the weight loss effects of such mediations). These state entities have warned that such compounded medication is not regulated and thus have not been evaluated for safety and effectiveness by the FDA.
About Duane Morris
Duane Morris regularly guides compounding pharmacies as to the best practices necessary to be fully compliant with federal and state guidelines and laws. Duane Morris will continue to monitor these lawsuits as well as continuing developments in the weight loss medication space, which will undoubtedly have an impact on pharmacies involved in the compounding and dispensing of such medications.
For More Information
If you have any questions about this Alert, please contact Jonathan L. Swichar, Bradley A. Wasser, any of the attorneys in our Pharmacy Litigation Group or the attorney in the firm with whom you are regularly in contact.
Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.