By Bhanvi Satija and Christy Santhosh
(Reuters) – Websites selling compounded versions of popular weight-loss drugs from Novo Nordisk and Eli Lilly to U.S. consumers often do not inform patients of the risks associated with these medicines, according to a research letter published on Friday.
More than half of the 79 websites reviewed by the researchers failed to disclose that their products were not approved by the U.S. Food and Drug Administration, 37% misleadingly implied FDA approval and 14% did not disclose they were selling compounded products, which are essentially copies of the name-brand drugs.
“The lack of FDA approval means there’s no verification of efficacy, no verification of safety,” said Yale University School of Medicine’s Ashwin Chetty, who is one of the authors.
Roughly half of the sites did not inform patients about side effects, warnings and precautions related to the drugs, and about 40% overstated the drugs’ benefits.
“I’m very worried about the internet compounding industry. Some of it, I’m sure, is very high quality, but it’s very hard, if you are ordering things on the internet, to know exactly what you’re getting,” outgoing FDA Commissioner Robert Califf said on Thursday at a media roundtable.
U.S. laws allow compounding pharmacies and facilities to produce compounded versions of FDA-approved drugs during shortages of the branded version. A tight supply of Novo’s semaglutide and Lilly’s tirzepatide – sold as Wegovy and Zepbound, respectively, for weight loss – has fueled demand for compounded versions.
Median first-month prices, including discounts, for the compounded drugs ranged from $231 to $330. Those without insurance coverage, however, pay $549 for Zepbound if ordered directly from Lilly’s pharmacy and $650 for Wegovy with a discount card from Novo.
Chetty and other authors identified 79 websites between July and September 2024 using Google Shopping to find businesses that advertised branded and generic forms of the so-called GLP-1 medications.
Their research does not include “every single website in existence that sells a compounded GLP-1,” Chetty told Reuters.
“It’s certainly possible that other websites have come into existence since then,” said Yale University’s Alissa Chen, who also authored the research.
Advertising of compounded drugs falls into a regulatory “gray area” and requires stricter oversight, the researchers said.
While direct-to-consumer advertising of compounded weight-loss drugs is not “illegal”, it hinders U.S. health regulators’ intent to provide patients access to safe medicines, said T. Joseph Mattingly of the University of Utah College of Pharmacy in a commentary published alongside the research.
Compounding laws “were not intended to create a window of time where opportunistic vendors exploit a shortage to gain market share and drive new demand through aggressive marketing tactics,” he added.
Advertisements for compounded products should be held to the same standards as those of prescription drugs, Mattingly recommended.
The authors of the study have received fees from Close Concerns, a non-profit organization focused on diabetes and obesity education. Mattingly has received grants from the Alliance for Pharmacy Compounding and the FDA.
(Reporting by Bhanvi Satija and Christy Santhosh in Bengaluru; Editing by Nancy Lapid and Anil D’Silva)
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