US Food and Drug Administration (FDA) Commissioner Marty Makary said the agency would target the mass-marketing of unapproved drugs amid ongoing opposition between drugmakers and online telehealth companies.
In a statement on X, Makary said: “The FDA will take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products. The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs.”
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The post comes after Hims & Hers, a telehealth company, announced it would launch a compounded version of Novo Nordisk’s Wegovy (semaglutide) pill. The copycat drug will be available from $49 for the first month and $99 afterwards. Novo Nordisk’s price for its oral drug is $149 for first-time users until mid-April and then $199 afterwards.
Though Makary’s pledge came after US stock exchanges closed, Hims & Hers strategy failed to win over investors during the day. Despite an initial rise, the telehealth company’s stock closed 12.4% down at market close on 5 February, dropping to $23.48 from a market open price of $26.80. After-hours trading led to further decline following Makary’s post.
Novo Nordisk conversely saw its stock rebound at market open on 6 February after dipping 7% the day before.
Compounded drugs are custom-made and unbranded medications that contain the same active ingredient as a marketed drug, such as semaglutide, pursuant to a prescription. While they are not FDA-approved, they can be made in certain situations, such as shortages or under personalised regimens.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataIn April, a US judge cleared the FDA to take enforcement action against compounders despite a lawsuit by an industry group.
Hims & Hers believes it is adhering to all applicable federal and state regulatory standards for compounding. Despite this, Novo Nordisk has threatened legal action against the compounder.
In a statement, Novo Nordisk said: “The action by Hims & Hers is illegal mass compounding that poses a significant risk to patient safety. Novo Nordisk will take legal and regulatory action to protect patients, our intellectual property and the integrity of the US gold-standard drug approval framework. This is another example of Hims & Hers’ historic behaviour of duping the American public with knock-off GLP-1RA products, and the FDA has previously warned them about their deceptive advertising of GLP-1RA knock-offs.”
Hims & Hers has built a name for itself in the glucagon-like peptide-1 receptor agonist (GLP-1RA) space for controversial reasons. In February 2025, it attracted anger from politicians and pharma companies over a Super Bowl commercial that attacked the US weight loss health system.
In an attempt to gain back market revenue lost to surging use of compounded drugs, Novo even partnered with Hims & Hers to offer branded Wegovy to the latter’s telehealth members in April 2025. However, Novo terminated the alliance just a month later after accusing Hims & Hers of failing to adhere to the law.
Amid the controversy, the share price in Hims & Hers is currently trading 60% down from a market high in May 2025, the month that contained FDA deadlines for compounders to stop producing their own versions of semaglutide.
Ahead of a difficult year, Novo is pinning much of its revenue growth on the Wegovy pill. However, Hims & Hers launching its own version is the latest chapter in unsuccessful efforts both by Novo and the FDA to enforce regulation on the compounded GLP-1RA sector.
In a research note, Citi analysts said: “While we have sympathy with Novo’s view, we are concerned that to date it has been unsuccessful in removing compounders from the market despite semaglutide being removed from the FDA shortage list in February 2025; hence, we see this as yet another overhang on the only bright spot in an otherwise difficult equity story.”
