Hims & Hers Abandons Weight-Loss Drug Plans Amid Regulatory Concerns

Hims & Hers recently decided to halt its intentions to market a combination version of its weight-loss medication Wegovy. This move comes after federal regulators indicated they would take action against telemedicine providers selling such drugs.

“Since we launched our combination semaglutide tablets, we’ve engaged in productive discussions with various industry stakeholders. Consequently, we’ve opted to stop offering access to this therapy,” the company stated.

Compounding—the process where pharmacies mix drugs to create versions of name-brand medications in different dosages—has gained traction among Americans looking for more affordable alternatives. It’s interesting to note that Hims & Hers’ weight loss pill was priced at $49 for first-time users, making it arguably the most affordable GLP-1 option currently available. In comparison, Novo Nordisk’s GLP-1 tablets retail for $149, while Eli Lilly plans to launch its versions on the upcoming Trump Rx website.

Following the announcement, Novo Nordisk’s stock took a hit, dropping to its lowest point since 2021, as the company expressed intention to take severe measures against this development.

“Novo Nordisk undertakes legal and regulatory actions to safeguard patients, our intellectual property, and the integrity of the U.S. drug approval system,” said Ambre James Brown, a spokesperson for Novo Nordisk.

It’s worth noting that compounding is permitted under certain conditions, particularly when a drug is in short supply or if a physician prescribes a specific dosage based on a patient’s unique needs. However, the specific drug in question hasn’t received approval from the Food and Drug Administration and hasn’t gone through clinical trials.

The FDA has stated that it will respond quickly to this situation, threatening to limit access to the drug’s ingredients and referring Hims & Hers to the Department of Justice.

FDA Commissioner Marty McCulley emphasized that the agency will use all available compliance and enforcement tools to address any unproven claims and related public health issues.

Following the FDA’s announcement, Hims & Hers saw its stock price fall by 14% on Friday.

“No one should be mass compounding or selling counterfeit GLP-1 products, regardless of the method of administration,” an Eli Lilly spokesperson remarked in a statement.