Additional Coverage:
- Hims & Hers removes a knock-off weight loss drug days after introducing it (businessinsider.com)
Hims & Hers’ Weight Loss Pill: A Swift Reversal After FDA Warning
Hims & Hers, the popular telehealth company, experienced a whiplash-inducing 48 hours this week, first launching a new daily weight-loss pill and then abruptly pulling it from the market after a swift warning from the Food and Drug Administration (FDA).
On Thursday, Hims & Hers introduced what it marketed as a once-a-day weight-loss pill. The company presented it as a more affordable, lower-dose alternative to existing injectable medications, particularly appealing to those hesitant about needles.
Essentially, it was a compounded version of semaglutide, similar to Novo Nordisk’s oral Wegovy pill, which debuted earlier this year. Hims & Hers initially stated that their product met “rigorous clinical standards” and adhered to all federal and state compounding regulations, sourcing active pharmaceutical ingredients from FDA-registered facilities.
However, the celebratory launch was short-lived. By Saturday, Hims & Hers announced it would cease offering the pill to customers. This quick reversal followed a stern statement from the FDA on Friday, which specifically called out companies, including Hims & Hers, for “mass-marketing” unapproved compounded GLP-1 drugs as alternatives to FDA-approved medications.
The FDA’s statement made its intentions clear: it plans to restrict ingredients used in such non-FDA-approved compounded drugs. The agency warned that entities failing to address these violations could face legal action, including seizures and injunctions, without further notice.
Compounding new versions of existing drugs is typically reserved for situations where there are shortages of the original medication. While some popular weight-loss and diabetes drugs have indeed faced periodic shortages in recent years, the FDA’s intervention suggests a broader concern about the mass production and marketing of these compounded alternatives.
The demand for weight-loss medications has surged since Novo Nordisk’s Ozempic, initially marketed for type 2 diabetes, gained popularity for its weight-management effects around 2022. This led Novo Nordisk to develop Wegovy specifically for weight management, available in both injectable and, more recently, oral forms. The high demand has spurred numerous health companies to create off-brand versions to capitalize on the market.
Hims & Hers’ rapid introduction and subsequent withdrawal of their compounded semaglutide pill highlight the complex regulatory landscape surrounding these popular medications and the FDA’s increasing scrutiny of their availability.
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- Hims & Hers removes a knock-off weight loss drug days after introducing it (businessinsider.com)