FDA Moves on Discount Drug Shakes Market

Clear Facts

• The FDA announced plans to take action against Hims & Hers over its $49 weight-loss pill, including possible legal referrals.
• The agency intends to restrict GLP-1 ingredients used in non-approved compounded drugs marketed as alternatives to authorized treatments.
• Hims & Hers’ compounded drug is not FDA-approved and has not undergone clinical trials for efficacy.

The Food and Drug Administration on Friday said it would act against Hims & Hers for selling a low-cost weight-loss pill by restricting use of its drug ingredients and referring the company for potential federal violations.

This move is expected to favor Novo Nordisk, which has faced growing competition from rival pharmaceuticals and telehealth companies like Hims.

The agency indicated it will target GLP-1 ingredients promoted in unapproved compounded products, citing quality, safety, and legal concerns.

On Thursday, Hims announced a new $49 per month offer for a version of Novo Nordisk’s Wegovy pill, undercutting the branded product’s price.

Novo Nordisk responded by stating it plans legal action against Hims for producing compounded copies of its medication.

Mike Stuart, General Counsel for the U.S. Department of Health and Human Services, stated he has referred Hims & Hers to the Department of Justice for investigation.

A spokesperson for Hims said the company “has always operated with a deep commitment to the safety and best interests of consumers and in compliance with applicable law.”

“We have a long history of successfully working with regulators, and look forward to continuing to engage with the FDA to ensure safe access to affordable healthcare.”

A spokesperson for Lilly said, “For years, compounders have been putting patients at risk by unlawfully mass-producing knockoff drugs using substandard ingredients from illicit foreign suppliers and selling them without clinical evidence that they’re safe or even work. Patients deserve better, and we look forward to decisive action by FDA, other regulators, and law enforcement.”

Compounding allows pharmacies to mix medications for specific patient needs or to provide alternatives during shortages, though it is only legal under certain conditions.

Hims’ compounded weight-loss drug lacks FDA approval and supporting clinical data.

According to legal experts, the FDA’s possible actions include sending a warning letter, seeking a court injunction, or seizing products. The agency would require the Justice Department’s assistance to pursue litigation.

Joanne Hawana of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. said, “this announcement by Hims, to the government, is concerning enough that they decided they’re going to escalate.”

In a statement, Commissioner Marty Makary said the FDA will “use all available compliance and enforcement tools within its authorities to address unsubstantiated claims and associated public health concerns.”

Regulators issued guidelines emphasizing that companies may not market non-approved compounded drugs as equivalent to FDA-approved medications or claim clinically proven results.

Stay informed as regulators push back against shortcuts in drug approval and promote patient safety.

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Full report at Daily Wire