Hims & Hers Drops Knockoff Wegovy Pill After FDA Warning
Company halted a compounded semaglutide pill after the FDA warned it would curb access to GLP-1 ingredients and Novo Nordisk threatened legal action.
Overview
Hims & Hers said on Saturday, Feb. 10, 2024, that it will stop offering a compounded semaglutide pill that it had announced on Feb. 8, 2024, company officials said.
The decision followed a Friday, Feb. 9, 2024, Food and Drug Administration statement saying it would take "decisive steps" to limit access to active ingredients used to make GLP-1 drugs, the agency said.
Novo Nordisk called Hims' planned product "an unapproved, inauthentic, and untested knockoff" and vowed on Feb. 8, 2024, to pursue legal and regulatory action, the company said.
Hims had planned to price its compounded semaglutide pill at $49 for the first month and $99 per month thereafter, undercutting Novo Nordisk's $149-per-month Wegovy list price, company listings show.
The Department of Health and Human Services said on Feb. 9, 2024, that it referred Hims to the Department of Justice for possible violations of federal law, leaving potential enforcement action pending, officials said.
Analysis
Center-leaning sources frame Hims as a profit-seeking actor that challenges regulatory norms by emphasizing legal and safety concerns. The coverage foregrounds Novo Nordisk’s legal threat and the FDA warning, contrasts pricing, and uses verbs like “capitalize” and “jump into” to suggest opportunism, while quoting Hims’ personalization claims as source content.
Sources (9)
FAQ
Semaglutide is a GLP-1 active pharmaceutical ingredient in FDA-approved drugs like Wegovy, used for treating type 2 diabetes and chronic weight management.
Hims & Hers halted the pill after FDA warnings on restricting GLP-1 ingredients, Novo Nordisk's threats of legal action calling it an unapproved knockoff, and a HHS referral to DOJ for potential federal law violations.
FDA established a 'green list' import alert to block unverified GLP-1 APIs, intends decisive steps against non-FDA-approved compounded drugs mass-marketed as alternatives, and combats misleading advertising.
Hims planned $49 for the first month and $99 monthly thereafter, undercutting Wegovy's $149-per-month list price.
Concerns include lack of FDA approval for safety, effectiveness, or quality, dosing errors, unapproved salt forms, adverse events requiring hospitalization, and risks from poor-quality foreign APIs.
History
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