Hims & Hers $HIMS ( ▲ 6.13% ) may have finally crossed a regulatory line. The telehealth company, which has long sold compounded versions of popular weight-loss drugs, is now under fresh scrutiny after launching a copy of Novo Nordisk’s $NVO new oral Wegovy pill. The big question hanging over the rollout: does it even work, and will regulators allow it to stay on the market?
Tensions escalated fast, pulling in pharma executives and the FDA in a very public standoff.
Novo Fires Back
Novo $NVO ( ▼ 0.65% ) CEO Mike Doustdar appeared caught off guard when asked about Hims’ plan to sell a compounded oral version of Wegovy at a starter price of $49 per month, far below Novo’s $149 cash-pay price. His response was blunt, suggesting patients would be wasting their money. Soon after, Novo threatened legal and regulatory action.
Then the U.S. Food and Drug Administration stepped into the spotlight. Commissioner Marty Makary posted that the agency would take swift action against companies mass-marketing “illegal copycat drugs.” While no firm was named directly, the timing made the target fairly obvious to investors and industry watchers.
The Science Question No One Can Ignore
Novo spent years and billions developing an oral version of semaglutide using proprietary delivery tech that protects the drug from stomach acid and helps it get absorbed. Even with that, patients must take it under strict conditions for it to work properly. That system has been validated in large clinical trials.
Hims’ version, made by partner pharmacy Strive, uses a different method described as liposomal technology meant to support absorption. There is no publicly available clinical trial data showing this approach works for semaglutide in humans. Some experts in the space have gone as far as saying the copycat pill almost certainly will not perform like Novo’s approved drug.
That gap between proven science and marketing claims is exactly where regulators tend to get uncomfortable.
A Loophole Under Pressure
Hims and other telehealth players originally leaned on compounding rules during past shortages of injectable GLP-1 drugs. Even after shortages eased, Hims continued selling versions it calls “personalized,” a legal gray area typically meant for rare patient-specific needs.
Pills make that argument harder. Unlike injectable doses that can be adjusted per vial, tablets are usually mass-produced in batches, which weakens the personalization claim. Some industry executives say this latest move stretches the compounding exemption to its breaking point.
Hims does not manufacture the pill itself, which could complicate legal responsibility. Still, with the FDA now publicly signaling tougher enforcement, the company’s once low-profile strategy has turned into a high-stakes regulatory fight.