Lexology September 12, 2025
Highlights
- The White House, Department of Health and Human Services (HHS), and Food and Drug Administration (FDA) announced their intent to take aggressive enforcement action to ensure that direct-to-consumer (DTC) prescription drug advertisements are compliant with current laws and regulations.
- The FDA signaled it will initiate rulemaking to modify current DTC advertising regulations and eliminate long-standing policy allowing the most important risk information to be included in broadcast advertisements with adequate provision for dissemination of full approved label information instead of a full summary of all risk information, as was generally required prior to 1997.
- While no new rules have been issued, the FDA announcement suggests they may attempt to reverse a recently implemented regulation requiring broadcast advertisements to...
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