With online health and wellness company Hims & Hers opening a new front in the GLP-1 compounding showdown Thursday, the United States’ top drug regulator has taken notice.
“FDA will take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products,” FDA commissioner Marty Makary, M.D., said in a Feb. 5 post on X. “The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs.”
Makary’s comments mark a clear and sharp rebuttal to Hims’ announcement earlier in the day that it had launched a compounded version of Novo Nordisk’s new Wegovy (semaglutide) pill for obesity, which starts at just $49 per month.
Approved by the FDA in late December, Novo’s pill launched on Jan. 5 at a $149-per-month starting price for cash-paying patients. The launch has gone gangbusters so far and is viewed as critical in Novo’s efforts to regain some of the obesity market dominance that it has ceded to Eli Lilly.
Novo investors seemed to respond well to Makary’s invective. Following the commissioner’s post, Novo’s stock was up more than 7% as of 9:30 a.m. ET on Friday, Feb. 6. Those gains were nearly enough to offset declines that came Thursday in response to the Hims announcement.
Notably, Makary’s wording closely resembles that of Novo itself, which accused Hims in a statement this week of attempting to “unlawfully mass-market an unapproved, inauthentic, and untested knockoff semaglutide pill.”
“The action by Hims & Hers is illegal mass compounding that poses a significant risk to patient safety,” the Danish drugmaker continued, pledging to take legal and regulatory action in response.
Novo’s concern primarily comes down to the Hims pill’s use of an “untested delivery mechanism that lacks supporting evidence and has never been reviewed by FDA,” the company said in an emailed statement Friday.
Whereas the genuine Wegovy pill contains salcaprozate sodium (SNAC) technology to make sure the body absorbs the treatment's active ingredient, semaglutide, Hims' compounded version uses a different liposomal technology, according to Novo.
“FDA has expressly identified this technology as posing significant safety and efficacy risks to patients, and patients who take this compounded product are potentially at risk for over- or under-dosing as improper mixing of liposomes with active pharmaceutical ingredients (like semaglutide) could cause the compounded drug product to be potentially hazardous or ineffective,” the statement continues.
In fact, the FDA has issued a proposed rule to add liposome drugs to its list of products that can’t be compounded, due in part to their complex formulation, delivery method and the release of the drug from the liposome, Novo pointed out.
Hims did not immediately respond to Fierce Pharma’s request for comment on the situation.
GLP-1 compounding has been a persistent thorn in Novo’s side. Early into the launches of Novo’s Ozempic and Wegovy—and Eli Lilly’s Zepbound and Mounjaro, for that matter—supply constraints led to protracted shortages, which allowed mass compounding of the drugs under federal law to help meet patient demand.
But both companies’ shortages have long since been resolved, and the Wegovy pill wasn’t in shortage to begin with. These days, compounders producing versions of Novo’s and Lilly’s GLP-1s are largely using the argument of “personalization” to ostensibly operate within legal bounds, suggesting that they are producing customized doses by adding vitamins, tweaking doses or altering delivery methods.
Producing bespoke doses for specific patients has long been another function of compounding pharmacies, but never on the scale witnessed with GLP-1s, experts told Fierce for a feature on the compounding situation last year.
In its launch announcement, Hims said that its compounded Wegovy pill uses a different formulation and delivery system than Novo’s FDA-approved product.
Efforts by Lilly and Novo to snuff out the compounded GLP-1 cottage industry through lawsuits have had mixed success, given the breadth of manufacturers that have cropped up.
But Makary’s comments suggest the FDA may be ready to crack down. And in light of the commissioner’s previous saber rattling around drug advertising, compounders might want to take notice.
Last September, his agency pledged to issue letters to drugmakers believed to have produced “misleading” or “deceptive” ads, with Makary calling the renewed enforcement push “overdue” in a JAMA editorial around the same time. The FDA swiftly followed through with its threat and has continued to steadily issue untitled letters to offending ads in the new year.
The government may be further encouraged to direct patients toward the branded Wegovy pill since it’s one of the first offerings on TrumpRx.gov, a newly launched, government-run website designed to direct cash-paying patients to drugmakers’ direct-purchasing channels.
In the case of the Wegovy pill, TrumpRx is also offering coupons that patients who aren’t using insurance can take to a pharmacy to get a discount from the drug’s list price.
Editor's note: This story has been updated with additional comments from a Novo Nordisk statement.