FDA Announces Crackdown on DTC Advertising: What It Means for Pharma and What Comes Next

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.