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FDA continues crackdown on DTC advertising for compounded GLP-1s
Continuing its crackdown on direct-to-consumer advertising, the FDA has sent 30 more warning letters to companies making deceptive claims about their compounded GLP-1 products.
The FDA has sent a second wave of warning letters to 30 telehealth companies for making "false or misleading claims" about compounded GLP-1 products advertised on their websites, the agency says.
These new letters, issued on Feb. 20, are part of the FDA's ongoing nationwide crackdown on deceptive direct-to-consumer advertising regarding compounded GLP-1 drugs launched last year, according to the agency's press release.
"It's a new era," FDA Commissioner Marty Makary, M.D., M.P.H., said in the release. "We are paying close attention to misleading claims being made by telehealth and pharma companies across all media platforms -- and taking swift action."
The first round of letters targeted more than 50 telehealth and wellness companies, including Hims & Hers. These companies were cited for selling unapproved or misbranded compounded versions of popular GLP-1 drugs, branded by Novo Nordisk and Eli Lilly, online to U.S. consumers.
The latest warnings come after Hims & Hers pulled back on offering a $49 compounded version of Novo's new Wegovy pill last month, following regulatory and legal pressure from the FDA and Novo Nordisk.
The retreat by one of the most prominent telehealth companies in the compounded GLP-1 space suggests the FDA's enforcement messaging is having an impact.
Just days before Hims & Hers reversed course, Markary posted on X that the FDA is prepared to take quick action against companies that mass-market illegal copycat drugs advertised as being similar to FDA-approved products.
"Compounded drugs can be important for overcoming shortages or meeting unique patient needs, but compounders should not try to compound drugs in a way that circumvents the FDA's approval process," Makary concluded.
Under current policy, compounding is allowed only for patient-specific medications on the national shortage list. Novo Nordisk's semaglutide and Eli Lilly's tirzepatide were added to the FDA's shortage list in 2022, but were removed over a year ago. Compounding pharmacies were given a 60-day window to wind down producing copies of the drugs.
Still, telehealth providers have continued to sell mass-produced compounded formulations under the guise of personalization.
Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.
