S. 483: Responsibility in Drug Advertising Act of 2025

This bill prohibits direct-to-consumer advertising of new drugs during the first three years following their approval by the Food and Drug Administration (FDA). Direct-to-consumer advertising includes advertising via social media.

Upon request from a drug’s sponsor, the FDA may waive the prohibition during the third year following a drug’s approval if it determines that the direct-to-consumer advertising of the drug would have an affirmative value to public health. Conversely, the FDA may prohibit such advertising beyond the three-year period following approval if it determines that the drug has significant adverse health effects based on post-approval studies, adverse event reports, and other appropriate resources.

The prohibition applies to new drugs approved beginning one year before the bill’s enactment.

Written by the Congressional Research Service, Library of Congress.