Unapproved obesity drug spawns a black market frenzy
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A next-generation Eli Lilly weight-loss drug that hasn't even been submitted for Food and Drug Administration review is already spawning a rash of cheap knockoffs that are being heavily touted on social media.
Why it matters: The experience with the drug, called retatrutide, shows how demand for GLP-1s and other peptides is outpacing the regulatory system.
- It's also supercharging a market driven by online influencers, medical spas and e-commerce platforms.
Driving the news: Eli Lilly recently filed six lawsuits against med spas, at least one compounding pharmacy and other vendors that the drugmaker said are stoking a black market for counterfeit retatrutide by pitching it as a weight-loss "hack."
- The company also is referring thousands of vendors and businesses to regulators and law enforcement, and pushing credit card processors and social media companies to cut off their ability to advertise and collect payments.
- "Black-market sellers openly sell what they claim to be retatrutide," a Lilly spokesperson told Axios in an email. "FDA and law enforcement should take the strongest actions allowed by law, including seizures, injunctions, and criminal prosecutions."
Between the lines: Lilly has gone to court before over unauthorized sales of its blockbuster weight-loss drugs Zepbound and Mounjaro. But retatrutide, a once-a-week injectable shown to help people lose up to 30% of their body weight, poses a different problem.
- There's a profusion of products marketed as retatrutide, despite the fact the drug isn't even approved for sale in the U.S. That's left Lilly fighting to protect future sales and guard against instances in which a product claiming to be its drug causes harm.
- Social media influencers have been touting knockoffs dubbed "r3ta" or "triple G." A quick Google search nets dozens of companies selling the drug for as much as $600.
The FDA has sent warning letters to multiple companies, some of which have labeled products for "research use only" while clearly pitching them for human consumption, a Department of Health and Human Services official told Axios. The agency has also worked with state law enforcement.
- But experts question how much the agency can do with limited staff and resources and a black market that's already flourishing.
- "We can talk all day long about the need for more enforcement, but that has to be funded and I'm not seeing any stomach in Congress for providing FDA additional funding for that," said Scott Brunner, CEO of the Alliance for Pharmacy Compounding.
Zoom in: Lilly's efforts to get sellers to cease and desist have had little effect to date. The company notably has not pursued claims of patent infringement, which could open up its intellectual property to new challenges, said Edgar J. Asebey, a partner at Frier Levitt.
- Instead, its lawsuits lean on state laws and consumer protection claims, seeking to take back "ill-gotten gains."
- "This seems to be like 'Let's throw the book at everybody,'" Asebey said.
Reality check: Some price-sensitive consumers are desperate enough to try untested products found on the internet.
- And certain products are actually helping some people lose weight, Asebey said.
What to watch: While Lilly pushes the FDA to crack down on black marketeers, it's locked in a separate fight with regulators over whether retatrutide should be classified as a biologic or a standard drug.
- A biologic designation would give the company 12 years of market exclusivity and block legal compounding, even in the case of a shortage.
- Courts have split on the question, returning the matter to the FDA for further review. Lilly has appealed and recently announced plans to submit a biologic license application for the drug in the first quarter of 2027.
