on PinterestHims & Hers has withdrawn its low cost compounded weight loss pill after pressure from top U.S. health officials and a major lawsuit.
on PinterestHims & Hers has withdrawn its low cost compounded weight loss pill after pressure from top U.S. health officials and a major lawsuit. Image courtesy of Novo Nordisk
- Hims & Hers recently announced a $49 compounded semaglutide pill, offering a low cost alternative to the new Wegovy pill.
- However, the compounded version was withdrawn from the market after pressure from the HHS and FDA.
- Hims & Hers now faces a lawsuit from Novo Nordisk for patent infringement.
- Experts say it’s unclear whether Hims & Hers’ pills perform as well as Wegovy, and while access and affordability matter, consumer safety comes first.
Telehealth provider Hims & Hers announced its plans for a compounded semaglutide pill on February 5, priced at $49 per month.
The new offering was intended to rival Novo Nordisk’s Wegovy weight loss pill, which made its debut on January 5 at a self-pay price of $149.
However, Hims & Hers has put the brakes on sales of its compounded version amid potential legal action from top health officials who said the drug violates U.S. regulatory laws.
On February 6, the Department of Health and Human Services’ (HHS) General Counsel Mike Stuart announced via X that he would refer the compounded drug to the Department of Justice (DOJ) for potential violations of the Federal Food, Drug, and Cosmetic Act, as well as possible offenses under Title 18 of the U.S. Code.
Hims & Hers swiftly responded on X, stating that after conversations with industry stakeholders, they’d decided to stop offering the compounded semaglutide pill.
“We remain committed to the millions of Americans who depend on us for access to safe, affordable, and personalized care,” the company wrote.
This came after an X post from Marty Makary, MD, Commissioner of the Food and Drug Administration (FDA), who stated that the agency would take action against any companies marketing what he called “illegal copycat drugs.”
Novo Nordisk itself announced on February 9 that it was suing Hims & Hers for patent infringement for both its compounded pill and its injectable semaglutide.
“Hims has engaged in promotional campaigns that highlight its compounded semaglutide products, duping consumers and healthcare professionals as to the clinical benefits and safety of these unapproved drugs,” the company said in a news release.
The drug manufacturing giant is seeking to halt Hims & Hers’ sales of compounded semaglutide products and recover damages. Healthline reached out to Hims & Hers for comment, but did not receive a response.
Compounded semaglutide raises safety concerns
James J. Chao, MD, FACS, co-founder and chief medical officer of VedaNu Wellness in San Diego, CA, said the concerns about safety stem from differences in how the pills are formulated compared to brand-name Wegovy.
“The active ingredient may be the same, yes, but everything else about the pill’s behavior in the body can change dramatically,” he told Healthline.
Chao explained that compounded pills might be mixed by hand in small batches without stringent bioequivalence standards.
“So a 2 milligram (mg) compounded semaglutide pill may not act anything like its brand-name counterpart,” he said. “Absorption can be off by upward of 30%, meaning one
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