Corporate Counsel reports on the U.S. Food and Drug Administration’s 30 recent warning letters to telehealth companies, cautioning them against marketing compounded versions of GLP-1 weight-loss and diabetes medications as equivalent to brand name products. The letters are part of an ongoing, broader enforcement push against compounded GLP-1s specifically.
Dominick DiSabatino, a member of Sheppard’s FDA Regulatory Compliance and Enforcement industry team, noted that GLP-1s have provided the test case for the FDA to decide about whether and how to make policy on telehealth marketing of compounded drugs more generally. He said that the agency is “in a tricky spot” between competing goals of protecting patient safety and promoting availability and affordability of the drugs. “Any agency is cognizant of whether and to what extent it’s impacting a consumer or commercial market. They have to do it the right way. They’re under a lot of scrutiny,” DiSabatino said.