Drug manufacturer Eli Lilly & Co. has sent cease-and-desist letters to U.S. healthcare providers demanding an end to the promotion and sale of copycat versions of the company's Mounjaro and Zepbound GLP-1 drugs, Bloomberg reported Aug. 15.
Zepbound has been approved by the FDA for weight loss; Mounjaro is approved to treat Type 2 diabetes but is prescribed off-label to treat weight loss.
"Lilly sent cease-and-desist letters to a number of med-spas, wellness centers, and telehealth providers. Any entity purporting to sell these compounded products under Section 503A should stop because when FDA-approved medicines are 'commercially available' compounders cannot regularly make 'essentially a copy' of them," an Eli Lilly spokesperson Lilly told Becker's.
The letters were also sent to brick-and-mortar clinics, according to Bloomberg.
Section 503A of the FDA's Federal Food, Drug, and Cosmetic Act allows drug compounders to make, promote and sell copycat versions of drugs during a shortage — and those versions are often less expensive.
Once a shortage is resolved and the manufacturer has a "built up sufficient safety stock," compounders must stop producing the copycat drugs, an FDA spokesperson told Bloomberg.
Mounjaro and Zepbound are tirzepatide injections and have been on the FDA's drug shortage list since Dec. 15, 2022, though the agency notes the drugs are currently available.
The Eli Lilly spokesperson said the company is exploring all options to "protect people" from the copycat drugs, which the company calls "illegal, unsafe, untested and unproven." The company says they are calling on "state and federal regulators to do the same."