On Tuesday, September 19th, Eli Lilly, the only pharmaceutical company with US FDA approval to sell tirzepatide drugs, announced that it was suing ten medical spas, wellness centers, and compounding pharmacies in the United States for marketing products that claimed to include tirzepatide, the active component of its diabetic medication Mounjaro, which is later this year anticipated to receive approval for use in weight loss.
Eli Lilly, based in Indianapolis, claims that the four compounding pharmacies, which create individualized medicine formulations for clients, are selling unlicensed versions of Mounjaro in violation of both federal and state laws protecting consumers and those governing competition.
“Defendants use Lilly’s trademark to attract customers and generate revenues and profits, including by passing off as ‘Mounjaro’ their own unapproved compounded drugs purporting to contain tirzepatide and doing so for a use for which Mounjaro is not approved, namely weight loss,” Eli Lilly said in the lawsuits.
The FDA issued a safety warning in May regarding the dangers of using compounded or specially produced copies of well-known weight-loss medications like Wegovy and Ozempic, sold by Novo Nordisk, stating that it has received reports of adverse events following the use of compounded forms of semaglutide by patients.
Tirozepatide has not yet received a compounding warning from the FDA. However, Mounjaro, Ozempic, and Wegovy have all been listed on the FDA's drug shortage list since last year. According to the FDA, compounders may be able to create a compounded version of a drug that is in short supply if they meet specific conditions of the Federal Food, Drug, and Cosmetic (FD&C) Act. But the organization does not evaluate these compounded versions for quality, safety, or effectiveness.
According to Lilly, compounded versions of tirzepatide can subject users to "potentially serious health risks," adding that “products claiming to contain tirzepatide that are made and/or distributed by compounding pharmacies or distributed by counterfeit sources have not been reviewed by the U.S. FDA or global regulatory agencies for safety, quality, or efficacy.”
Once it is approved to treat obesity, analysts and business leaders have predicted that yearly sales of weight-loss medications may reach $100 billion within a decade, with Lilly's medicine potentially accounting for more than half of those sales.
(Input from various media sources.)
(Rehash/Rukhiya Naduvile Purayil)