Joint FDA/HHS Initiative Targeting Direct-to-Consumer Pharmaceutical Advertising Garners Much Attention, but Legal Basis and Likely Impact Are Unclear

Executive Summary

What is new: On September 9, 2025, HHS and FDA announced a new initiative to close a purported loophole in FDA’s regulations regarding the adequate provision of safety information in direct-to-consumer pharmaceutical advertising.

Why it matters: Direct-to-consumer advertising is likely to come under increased scrutiny, but whether FDA will follow through with, or succeed in implementing, regulatory changes remains to be seen.

What to do next: Companies may want to ensure robust review processes are in place for all direct-to-consumer advertising, including social media advertising, and stay tuned to see whether any further regulatory activity occurs.

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On September 9, 2025, the Department of Health and Human Services (HHS) and Food and Drug Administration