Legal Scrutiny of Hims' Compounded Wegovy Copy

The Trump administration is considering legal action against Hims and Hers Health (HIMS.N) for its brief attempt to market a compounded version of Novo Nordisk's Wegovy weight-loss pill. This potential action follows Hims' announcement of a $49 alternative to Wegovy, which was quickly retracted after the Food and Drug Administration (FDA) indicated it would take enforcement steps against the company.

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Hims' compounded version of Wegovy raises questions under the Food, Drug, and Cosmetic Act, which regulates the marketing of pharmaceuticals. The FDA has referred Hims to the Department of Justice (DOJ) for possible violations, including the marketing of an unapproved drug. Legal experts suggest that the DOJ could pursue an injunction or impose civil or criminal fines against Hims. The FDA's actions are partly motivated by a desire to protect the investments made by pharmaceutical companies in obtaining FDA approval for their products, as noted by Mike Stuart, general counsel for the Department of Health and Human Services (HHS).

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Hims has defended its actions by claiming that its products are tailored to meet specific patient needs, which they argue makes them permissible under federal law. However, the legality of their compounded drugs hinges on whether they are sufficiently personalized, a determination complicated by limited public information regarding Hims' manufacturing and prescription practices.

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As a next step, the FDA may inspect Hims' records to assess the legitimacy of its prescriptions, potentially in collaboration with state regulators. The company's decision to withdraw its compounded weight-loss pill could influence the DOJ's decision on whether to pursue legal action. Legal experts suggest that if Hims has indeed ceased its plans, the case may lack sufficient controversy for the DOJ to act.

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The scrutiny of Hims comes amid a surge in demand for weight-loss drugs, with major manufacturers like Novo Nordisk and Eli Lilly (LLY.N) struggling to meet consumer needs. The FDA has previously warned Hims and other companies about misleading advertising practices, indicating a broader regulatory focus on the marketing of weight-loss medications.

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There is uncertainty regarding the extent of Hims' compliance with federal regulations, as well as the potential legal ramifications of their compounded products. The lack of detailed public information about Hims' manufacturing processes complicates the assessment of their legality.

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• “When you look at compounders versus the pharmaceutical industry generally, these compounders haven’t spent that inordinate amount of money making sure that they’re safe and effective." — Mike Stuart, General Counsel, HHS

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• "If Hims has already stepped back and is saying we’re not going to do this, it’s not clear there’s a case or controversy here." — James Boiani, Attorney, Epstein, Becker & Green, P.C.

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• "If the FDA refers something, then Justice typically acts on it." — James Shehan, Chair of FDA Regulatory Practice, Lowenstein Sandler

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The situation surrounding Hims and its compounded Wegovy alternative illustrates the complexities of pharmaceutical regulation and the ongoing challenges faced by the industry in meeting consumer demand while adhering to legal standards.

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