Hims & Hers Withdraws Low-Cost Weight Loss Pill Amid Regulatory Pressure and Lawsuit Telehealth provider Hims & Hers has withdrawn its compounded semaglutide weight loss pill from the market due to pressure from top U.S.
Hims & Hers Withdraws Low-Cost Weight Loss Pill Amid Regulatory Pressure and Lawsuit
Telehealth provider Hims & Hers has withdrawn its compounded semaglutide weight loss pill from the market due to pressure from top U.S. health officials and a lawsuit filed by Novo Nordisk, the manufacturer of Wegovy.
- Hims & Hers had previously announced a $49 compounded semaglutide pill as a low-cost alternative to Wegovy, which debuted at a self-pay price of $149.
- The company faced pressure from the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA), who stated that the drug violated U.S. regulatory laws.
- Novo Nordisk has sued Hims & Hers for patent infringement, seeking to halt sales of compounded semaglutide products and recover damages.
The withdrawal of the compounded pill raises concerns about consumer safety. Experts note that while access and affordability are important considerations, the safety of patients must come first.
Compounded Semaglutide Raises Safety Concerns
Dr. James J. Chao, co-founder and chief medical officer of VedaNu Wellness in San Diego, CA, notes that compounded pills may have different formulations compared to brand-name medications like Wegovy.
"The active ingredient may be the same, but everything else about the pill's behavior in the body can change dramatically," Dr. Chao explained. "Compounded pills are often mixed by hand in small batches without stringent bioequivalence standards."
This raises concerns that a 2 milligram (mg) compounded semaglutide pill may not act like its brand-name counterpart, with absorption potentially off by up to 30%.
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