FDA Faces High Hurdle to Expand DTC Ad Disclosures: WLF
A 2/11 Washington Legal Foundation legal backgrounder argues that FDA would face steep statutory hurdles if it attempts to dramatically expand disclosure requirements in direct-to-consumer (DTC) pharmaceutical advertising, contending that such a move would likely fail in court under the Supreme Court’s 2024 decision in Loper Bright.
Authored by senior litigation counsel Zac Morgan, the paper comes amid what HHS secretary Robert F. Kennedy Jr. has described as a “crackdown” on DTC drug ads. FDA commissioner Marty Makary has publicly signaled a more aggressive posture toward pharmaceutical advertising. While Kennedy has previously called for banning DTC drug ads altogether, the backgrounder notes that an outright prohibition would raise serious First Amendment concerns. Instead, the paper suggests regulators may seek to reshape ad content by mandating significantly longer or more prominent side-effect disclosures.
Under the Federal Food, Drug, and Cosmetic Act (FDCA), DTC advertisements must include a “major statement” on side effects and contraindications presented in a “clear, conspicuous, and neutral manner,” along with certain contact information. The statute authorizes HHS to require additional “brief summary” information through regulation. Current FDA rules require that audio disclosures be readily understandable, visual elements be easy to read, and that no elements interfere with comprehension.
Morgan argues that these statutory terms do not grant the agency open-ended discretion. Citing Loper Bright, which ended Chevron deference to agency interpretations of ambiguous statutes, the paper contends that courts must now determine the “single, best meaning” of statutory language without deferring to an agency’s “permissible” construction. In that framework, the backgrounder maintains, requiring disclaimers to consume a large portion of an advertisement or mandating stark visual presentations during side-effect disclosures would exceed the statute’s limits.
The paper interprets “clear, conspicuous, and neutral” as aimed at ensuring consumer comprehension, not authorizing regulators to tilt messaging against a product. Imposing lengthy spoken disclaimers or requiring negative imagery, it argues, could transform a neutral disclosure into what it characterizes as compelled counter-speech, effectively undermining the advertiser’s message rather than clarifying risk information.
Beyond statutory interpretation, the backgrounder frames the issue in economic terms, noting the high cost of drug development and arguing that advertising revenue is integral to sustaining pharmaceutical innovation. Congress has not amended the FDCA to impose stricter compelled-speech requirements for drug ads, the paper concludes, and absent such legislative action, HHS lacks authority to substantially expand the scope or presentation of mandated disclosures.