Ongoing shortages of popular weight loss and diabetes drugs in the U.S. have spurred fierce competition between established drugmakers and an emerging market of compounded versions as telehealth companies look to tap into the fast-growing industry.
GLP-1 medications like Ozempic and Mounjaro have become highly popular for their ability to aid weight loss. According to the health policy nonprofit KFF, 1 in 8 U.S. adults has taken a GLP-1 medication.
This skyrocketing demand has contributed to years-long shortages of drugs like semaglutide and tirzepatide, the active ingredients of Ozempic and Mounjaro, respectively. When medications are in shortage, compounding pharmacies are allowed to provide copycat drugs to help patients continue receiving care.
Major telehealth companies like Hims & Hers and Noom are taking full advantage of this scenario.
“There's never been such a demand, or a mismatch between branded supply and demand, that has driven this kind of explosion in compounding pharmacies and online platforms that basically deliver or create access for product,” said Jaime Almandoz, medical director of the University of Texas Southwestern Medical Center Weight Wellness Program.
Pharmaceutical giants have opened a legal battle against companies that provide semaglutide products not sourced from them directly. Neither Hims & Hers nor Noom has been sued by the manufacturers as of writing.
Apart from industry outcry, federal agencies have signaled some concern over reports of adverse events linked to compounded semaglutide due to patients miscalculating self-administered doses.
Regulatory gray zone
Compounded drugs are not generic forms of the medications they’re meant to replace, and while compounding pharmacies are regulated by the Food and Drug Administration (FDA), the products they sell are not FDA-approved.
Compounding pharmacies typically produce altered forms of medications for patients who are unable to take the FDA-approved version. This may be because they’re allergic to a dye used in making the medicine or they’re unable to swallow pills.
There are two types of compounding pharmacies: 503A facilities........