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Telehealth Labs Skirt Drug Rules for Profits
20 Apr
Summary
- Hims & Hers offers accessible healthcare, but faces regulatory scrutiny.
- The company profits from compounded GLP-1 drugs, bypassing traditional rules.
- Congress urged to clarify compounding necessity and boost adverse event reporting.
Hims & Hers has experienced a surge in subscribers, nearly doubling to 2.5 million in four years, by offering a more accessible and affordable alternative to traditional US healthcare. The company initially sold lifestyle products online but expanded into compounded drugs, reformulating FDA-approved medicines for specific needs.
Their business model gained significant traction with the high demand for GLP-1 anti-obesity drugs. Hims utilized its compounding facilities to provide these medications, even after shortages ended, by interpreting rules around clinical necessity loosely. This led to hundreds of millions in revenue from personalized GLP-1s, often with added vitamins or altered dosages.
Concerns have been raised as compounded drugs are not as strictly regulated as traditional pharmaceuticals, with less monitoring of adverse events. This has led to instances of overprescribing and potential dosing errors. In response, the FDA has pledged to increase enforcement against improper compounding practices.
Industry giants like Novo Nordisk and Eli Lilly have challenged Hims' practices, leading to legal action and eventual agreements. While these partnerships may offer some patients better access, broader legal ambiguities remain. Experts advocate for congressional intervention to ensure compounded drugs offer a clinically significant difference and to enhance adverse event reporting, while also considering reforms to burdensome manufacturing regulations.
