Dive Brief:
- Eli Lilly on Wednesday said it’s filed six new lawsuits as part of an effort to combat black-market sales of one of its still-experimental obesity medicines.
- The drug, called retatrutide, has delivered powerful results in Lilly’s research to date, in some cases offering weight loss on par with bariatric surgery. But the company is still compiling data and doesn’t even plan to submit an application for Food and Drug Administration approval of the medication until next year.
- In the meantime, some people have been so eager to get their hands on retatrutide that they are resorting to online merchants, clinics, compounders and foreign companies that purport to offer a version of Lilly’s product. The substances in this black market could be fake, impure or mis-dosed, posing a myriad of dangers to consumers, Lilly said.
Dive Insight:
Lilly is seeking the help of courts, regulators and law enforcement agencies at a time when top U.S. health official Robert F. Kennedy Jr. appears inclined to give a freer rein to unreviewed substances in the medical marketplace. In July, an FDA advisory panel endorsed broader use of six peptides for various ailments without substantial evidence of their safety and effectiveness.
Lilly’s fight has also been made more difficult by the increasing use of pharmacies and companies that offer compounded versions of obesity medicines. They rose to prominence in the early days of the GLP-1 drug explosion, when Lilly and rival Novo Nordisk couldn’t keep up with demand, and have continued to steal market share even after the FDA proclaimed the shortage over and told them to stop sales.
The increasing trend of consumers searching for treatments outside the traditional medical system is dangerous, Lilly said. In the case of retatrutide, no regulatory agency anywhere in the world has approved the medicine. “Yet black-market sellers and businesses posing as legitimate medical providers openly sell retatrutide as a weight-loss ‘hack,’” Lilly said.
“These `medical spas,’ `wellness clinics,’ and self-styled suppliers are not practicing medicine; they are selling illegal drugs,” the company added.
Lilly said it has already referred more than 200 people and entities to regulators, professional licensing boards and law-enforcement officials as a result of the black-market trade. It’s also flagged more than 14,000 websites, ads, social media posts and product listings in over 100 countries.
The entities offering retatrutide aren’t all “shadowy online vendors,” CBS News reported in June. CBS found dozens of professional clinics advertising the drug along with compounding pharmacies, including Striker Pharmacy, one of the entities now being sued by Lilly.
Lilly also sued Aesthetic Envy, Astra Peptides, Legendary Peptides, Texas Peptides and Lone Star Peptide, targeting several for claims that they sell retatrutide for “research use only” products.
Legendary Peptides had no immediate comment on the lawsuit. Representatives for the other five companies didn't immediately respond to requests for comments.
