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The US Food and Drug Administration (FDA) said on Friday it would take action against telemedicine provider Hims & Hers over its $49 weight-loss pill. This would include restricting access to the drug's active ingredients and referring the company to the Department of Justice for possible violations of federal laws.
A federal crackdown to limit the manufacture of compounded drugs would be a win for Novo Nordisk, which is losing market share in the weight-loss drug market to rival Eli Lilly and telemedicine providers such as Hims. However, the FDA did not make it clear whether it could stop sales of the Hims product, the cheapest GLP-1 therapy on the US market, in the short term.
Shares of Hims fell 14.1% in after-hours trading.
The FDA announced it would restrict the use of GLP-1 agents in unapproved compounded drugs that companies like Hims and other pharmacies market as alternatives to approved treatments. The agency cited concerns about quality, safety and possible violations of federal law.
On Thursday, Reuters first reported that Hims would offer copies of Novo Nordisk's new Wegovy pill at an introductory price of $49 a month, about $100 less than the original product.
Novo Nordisk then announced it would take legal action against the telemedicine company over its plan to sell compounded copies of the drug.
The General Counsel of the US Department of Health and Human Services, Mike Stuart, also announced on Friday that he had referred Hims & Hers to the Department of Justice for possible violations.
Hims said in a statement that the company had "always acted with a strong commitment to the safety and well-being of consumers and in accordance with applicable law."
"We have a long history of successful collaboration with regulators and look forward to continuing to work with the FDA to ensure safe access to affordable health care."
Novo Nordisk spokeswoman Liz Skrbkova said in a statement: "We welcome today's actions by HHS and FDA to protect patients from unapproved copycat drugs made with foreign, inauthentic active pharmaceutical ingredients that can pose significant risks to patient safety."
A Lilly spokesperson said the company welcomes the FDA's action. "For years, compounders have put patients at risk by unlawfully manufacturing and selling copycat drugs on a large scale with inferior ingredients from illegal foreign suppliers, with no clinical evidence of their safety or efficacy. Patients deserve better, and we look forward to decisive action from FDA, other regulators and law enforcement."
ENFORCEMENT OPTIONS
Compounding, in which pharmacies mix active ingredients for specific drugs or recreate a drug in other dosages, has gained prominence in the U.S. as Americans seek less expensive drugs.
This practice is legal under certain circumstances under the Federal Food, Drug and Cosmetic Act, such as when prescribed by a physician to treat a patient's side effects or in the event of a drug shortage.
Hims' compounded drug is not FDA-approved and has not undergone clinical trials for efficacy.
FDA enforcement actions against Hims could include sending a warning letter, seeking a court injunction or administrative seizure of products, according to Joanne Hawana, a member at Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
The agency needs the support of the Department of Justice to enforce an injunction because it lacks independent standing to sue, Hawana said.
According to Hawana, the FDA's statements indicate that "this announcement by Hims is so worrisome to the government that they have decided to escalate the matter."
TAKING ACTION AGAINST ADVERTISING
To date, FDA action on weight loss drugs has been limited to warning letters sent in the fall of 2025 to combat misleading direct-to-consumer advertising and marketing.
Commissioner Marty Makary stated on Friday that the agency will "use all available compliance and enforcement resources within its jurisdiction to address unsubstantiated claims and related public health concerns."
The regulator emphasized that companies may not claim in promotional materials that non-FDA-approved compounded products are generic or identical to FDA-approved drugs.
It added that "they also may not state that compounded drugs contain the same active ingredient as FDA-approved drugs or that compounded drugs have been clinically proven to achieve results in patients."
