FDA DTC Ad Crackdown Raises Legal Issues: Attorneys
Five Sidley attorneys say the FDA 9/2025 crackdown on direct-to-consumer (DTC) prescription drug ads has involved Warning and Untitled Letters that were issued to drug manufacturers that articulate positions that “raise significant constitutional, legal, and regulatory concerns.” Their legal update notes that a recent Untitled Letter directly conflicts with a position the agency stated in a Warning Letter issued more than 20 years ago, which recognized that factual statements about a medical product’s approved indications are truthful, non-misleading, and not objectionable.
The attorneys say it is not completely clear what is motivating FDA, and suggest that the agency has adopted an “I know it when I see it” approach to regulating imagery in advertising, and will see “it” when any kind of creativity is involved in a DTC ad for a prescription drug.
“FDA’s crackdown seems destined to collide with the well-established principle that truthful and non-misleading speech, including commercial speech, is entitled to substantial First Amendment protection,” the post concludes. “That principle requires meaningful evidentiary and analytical support for enforcement-related actions that, at bottom, target the alleged implications of factual statements about an approved prescription product. Such support appears lacking here…. More broadly, the development raises significant questions regarding the predictability and stability of FDA precedent, the evidentiary basis required for promotion-related enforcement actions, and the potential for constitutional and administrative law challenges where truthful, non-misleading speech is targeted.”
Going forward, the attorneys write, drug companies, particularly those using DTC promotion, should carefully assess both existing campaigns and future creative strategies in light of the shifts in FDA promotion policy. They say companies may wish to implement enhanced legal and regulatory review of comparative messaging, even where it is limited to factually accurate statements regarding approved indications, and to document the substantiation and rationale supporting such claims. Sponsors should also, they say, evaluate whether the agency could characterize tone, imagery, and other creative elements as implying unsubstantiated superiority even in the absence of express comparative claims.