S 483

This bill, the Responsibility in Drug Advertising Act of 2025, restricts direct-to-consumer advertising of new drugs for the first three years after FDA approval. While the FDA can grant a waiver to allow advertising during the third year if it deems it beneficial to public health, it can also prohibit advertising beyond that period if post-approval studies reveal significant adverse health effects. The bill applies to drugs approved one year before the bill’s enactment and includes provisions for the FDA to revise advertising regulations.