Lexology September 15, 2025
The White House issued a memorandum on September 9, 2025 directing the secretary of the US Department of Health and Human Services (HHS) and the commissioner of the US Food and Drug Administration (FDA) to significantly increase its enforcement of the Federal Food, Drug, and Cosmetics Act (FFDCA) and its rules governing direct-to-consumer (DTC) prescription drug advertising. In response, FDA issued an announcement regarding planned rulemaking and more immediate enforcement actions and strategies.
This initiative heralds a new era of regulatory scrutiny of drug advertising practices, and although the full scope and long-term impact of this initiative remain uncertain, the implications for the pharmaceutical industry are likely significant. In light of signaled increases in enforcement, companies should reassess existing promotional...
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