USFDA Flags Misleading Claims on Compounded Semaglutide, Tirzepatide Products
Bengaluru: The U.S. Food and Drug Administration issued 25 warning letters to telehealth companies for marketing false and misleading claims about compounded versions of Eli Lilly and Novo Nordisk's hugely popular weight loss and diabetes drugs.
The letters, that were posted on the health regulator's website on Tuesday, were sent to companies like Medica Weight Loss, Ready Med, Clover Meds among others earlier this month.
The health regulator previously sent a series of warning letters to telehealth firms as part of its broader crackdown on compounded drugs.
Some telehealth companies claimed on their websites that their compounded versions of Lilly's tirzepatide and Novo's semaglutide were sourced from FDA approved pharmacies or were the ingredients were clinically studied, the regulator said in the letters.
For others, the agency noted the representations made by the telehealth firms regarding compounded semaglutide and tirzepatide products are false or misleading. Some companies made claims that their compounded products were the same as approved GLP-1 drugs or displayed their products in a way which showed they compounded the drugs.
Lilly's tirzepatide is the active ingredient obesity injection Zepbound and its diabetes drug Mounjaro, while semaglutide is used in the Danish drugmaker's diabetes drug Ozempic and weight-loss drug Wegovy.
"Patients deserve to know what they're getting - compounded GLP-1 products have not been proven safe, effective, or of consistent quality like FDA-approved drugs," Michael Davis, acting director of FDA's Center for Drug Evaluation and Research said in a post on social media platform X.
"We will continue holding companies accountable."
These versions are customized medicines made when a licensed pharmacist or physician combines, mixes or alters drug ingredients to meet the needs of an individual patient. They are not approved by the FDA.
The agency in April proposed excluding Novo Nordisk and Eli Lilly's weight-loss drugs from a key compounding list, potentially limiting large-scale production by outsourcing facilities.
