Drugs

Lilly Files Six Lawsuits Over Illegal Retatrutide Sales

Eli Lilly has filed six new lawsuits against U.S. entities it alleges are selling illegal, unapproved retatrutide products, escalating the drugmaker’s efforts to shut down what it describes as a growing black market for the investigational medicine. The company says it has also referred more than 200 individuals and entities to FDA, Department of Justice, state attorneys general, law enforcement agencies and professional licensing boards. The company adds that it is working with regulators, customs authorities and law enforcement agencies worldwide to combat the sale of unauthorized retatrutide.

Retatrutide is the company’s investigational medicine being studied in Phase 3 clinical trials for obesity, Type 2 diabetes and related indications. Lilly notes no medicine containing retatrutide has been approved for human use by any regulatory agency and that the drug cannot legally be sold to consumers. “What's being sold on the black market is not a medicine – it is entirely unverified, unapproved and not worth the risk,” Lilly chief medical officer David A. Hyman is quoted in a release as saying.

The company says the defendants in the new lawsuits include compounding pharmacies, medical spas and online sellers that market retatrutide under claims that it is intended only for research use. It has reported more than 14,000 Websites, advertisements, social media posts and product listings marketing retatrutide illegally in more than 100 countries to internet service providers, social media platforms and e-commerce companies, according to the release.

The drugmaker is calling on social media and e-commerce platforms to take proactive steps to prevent the marketing and sale of illegal retatrutide. Lilly also urged credit card companies, payment processors, shipping companies and logistics providers to cut off services used by sellers to conduct the business.

The company notes that FDA has made clear that unapproved retatrutide cannot be legally sold to consumers or lawfully compounded, while products marketed as “research-use only” may be of unknown quality and potentially harmful. It urges regulators and law enforcement agencies to prioritize enforcement against sellers and coordinate across borders to disrupt what it characterized as criminal networks supplying unauthorized products.

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