Hims & Hers Health Inc. (NYSE:HIMS) has decided to cease offering its compounded semaglutide pill.
Hims & Hers Explains Its Decision
Hims & Hers’ decision to stop offering the $49 version of Novo Nordisk A/S’ (NYSE:NVO) Wegovy comes days after the company launched it.
“Since launching the compounded semaglutide pill on our platform, we’ve had constructive conversations with stakeholders across the industry. As a result, we have decided to stop offering access to this treatment,” the company said in a post on X.
Despite this decision, Hims & Hers emphasized their ongoing dedication to delivering safe, affordable, and personalized healthcare to millions of Americans.
FDA’s Warning
On Friday, the U.S. Food and Drug Administration (FDA) warned that it intends to take steps to restrict GLP-1 active pharmaceutical ingredients (APIs) intended for use in non-FDA-approved compounded drugs that are being mass-marketed by companies, including Hims & Hers.
“These actions are aimed to safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy,” the agency said in its announcement.
Mike Stuart, General Counsel to the Department of Health and Human Services (DHHS), said that his office has referred Hims & Hers to the Department of Justice for an investigation.
“Based on a review of the applicable facts, earlier today @HHSOGC referred Hims & Hers Health, Inc. (“Hims”) to the Department of Justice for investigation for potential violations by Hims of the Federal Food, Drug, and Cosmetic Act and applicable Title 18 provisions,” he said in a post on X.
Dropped Days After Introduction
Hims & Hers introduced the pill as a needle-free alternative to Wegovy, priced at an introductory rate of $49 for the first month.
This launch initially led to a surge in Hims & Hers stock, which soared to new highs.
Novo’s Legal Threat
However, the launch was met with legal threats from Novo Nordisk, which accused Hims & Hers of violating laws related to the mass sale of compounded drugs. The pharmaceutical giant claimed that Hims & Hers engaged in deceptive marketing practices that compromised patient safety.
Hims & Hers’ stock has previously faced pressure amid its ongoing legal battles with Novo Nordisk and allegations of non-compliance with drug compounding regulations.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Photo courtesy: Shutterstock
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