Regulating Direct-to-Consumer Prescription Drug Advertising in the United States

Policy Points The United States is an outlier in its permissive regulatory landscape for direct-to-consumer (DTC) advertising of prescription drugs. The First Amendment is a barrier to banning DTC prescription drug promotion, but it is not a barrier to addressing false, deceptive, or unfair advertising, which may include forms of influencer and social media promotion. The learned intermediary doctrine shields drug manufacturers from liability in most states, even when they engage in pervasive DTC advertising that leads to consumer misunderstanding. State courts and legislatures should reconsider this doctrine to ensure that consumers are adequately protected. The US Food and Drug Administration needs increased resources and additional authority over the promotion of compounded drugs.

The United States is an outlier worldwide in its permissive regulatory landscape for direct-to-consumer (DTC) prescription drug promotion. Recent proposals to restrict DTC prescription drug advertising raise questions about potential challenges under the First Amendment of the U.S. Constitution which protects commercial speech. Prescription drugs are unique in that they require a healthcare provider (HCP) to prescribe the product; the HCP serves as a "learned intermediary" between the pharmaceutical company and the consumer of the product. Under the learned intermediary doctrine, pharmaceutical companies satisfy their duty to warn consumers about drug risks by warning HCPs, and are thereby shielded from tort liability even if consumers rely on their advertisements and are harmed.

Using government websites and Lexis+, we researched statutes, regulations and case law related to the First Amendment's protection of commercial speech, the statutory and regulatory framework for DTC prescription and compounded drug promotion, and the learned intermediary doctrine.

The Food and Drug Administration (FDA) oversees DTC prescription drug promotion but lacks comparable authority over compounded drug promotion. Certain forms of DTC advertising may be particularly misleading and warrant increased FDA oversight. Although commercial speech is broadly protected under the First Amendment, false, deceptive and misleading commercial speech can be regulated or restricted. FDA issued guidance to industry for traditional media promotion, but lacks guidance on social media, online telehealth, and influencer-generated content. The learned intermediary doctrine was created by state courts before the advent of DTC advertising and now provides perverse incentives to companies to aggressively market their drugs without consequence.

Congress should provide FDA with equal authority over compounded drug promotion as it has for prescription drug promotion. FDA should issue regulations or guidance on modern forms of DTC advertising. The learned intermediary is based on outdated concepts and should be reconsidered by state legislatures and courts.