Prescription drug advertising in the United States has expanded beyond traditional television commercials to include social media, online pharmacies, and influencer endorsements. This shift raises questions about whether current regulations are sufficient to protect consumers, especially as compounded versions of drugs like GLP-1s—weight loss medications mixed and promoted by pharmacies rather than pharmaceutical companies—become more widely advertised despite lacking FDA approval.
A recent legal analysis published in the Milbank Quarterly explores whether direct-to-consumer pharmaceutical marketing rules have adapted to modern information channels and prescribing practices. The study examines relevant laws, court cases, and regulatory oversight by agencies such as the Food and Drug Administration (FDA) and Federal Trade Commission (FTC).
Jennifer Pomeranz, associate professor at NYU School of Global Public Health and former pharmaceutical defense lawyer, co-authored the analysis with colleagues from Harvard Law School and Tufts Friedman School of Nutrition Science and Policy. “Our analysis is especially timely given the evolving political landscape and bipartisan support for protecting patients from deceptive drug ads,” said Pomeranz.
According to Pomeranz, only New Zealand and the United States allow direct-to-consumer marketing of pharmaceuticals among high-income countries. She explained that U.S. support for large corporations often takes precedence over public health concerns. Additionally, the First Amendment protects commercial speech—including advertising—making it difficult for the government to ban truthful ads unless they are false or misleading.
The FDA has overseen prescription drug advertising since the 1960s but does not require companies to submit ads before airing them. “The FDA should have the authority—and the resources, through user fees—to require companies to submit ads before they are shown to the public,” Pomeranz stated. The FTC also regulates influencer marketing but existing FDA guidance on social media is outdated.
Current regulations place responsibility on healthcare providers under a legal principle known as the “learned intermediary doctrine.” This doctrine holds that pharmaceutical companies must warn prescribers about risks but not consumers directly. As a result, patients may have limited recourse if misled by advertisements. Some states have created exceptions; for example, Massachusetts courts ruled that birth control pills do not fall under this doctrine due to patient involvement in requesting them.
Pomeranz questioned whether this doctrine remains appropriate: “The learned intermediary doctrine provides perverse incentives to companies to aggressively market their drugs without consequence.” She suggested that state legislatures should reconsider its application, particularly for heavily marketed drugs like GLP-1s.
Telehealth startups and online pharmacies further complicate matters by allowing patients access to prescriptions without direct interaction with healthcare providers. In some states, an online questionnaire suffices instead of a physical exam or consultation.
Regarding compounded weight loss drugs such as GLP-1s, Pomeranz noted that these products fall into a regulatory gap because compounding is regulated by states rather than the FDA. “There are so many holes in the regulation of compounding in general that the marketing is falling into this abyss—no one seems to really be overseeing it,” she said.
To address these gaps, Pomeranz recommended expanding FDA authority over compounded drug promotion or increasing enforcement actions by state attorneys general and the FTC against deceptive practices.
This research was supported by funding from the National Institutes of Health (NHLBI 2R01 HL115189).
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