Responsibility in Drug Advertising Act of 2025

S 483, the Responsibility in Drug Advertising Act of 2025, prohibits direct-to-consumer advertising of newly approved drugs for the first three years after approval, with a possible waiver for the third year if the drug sponsor demonstrates public health benefits. After the initial three years, the FDA may ban such advertising if post-approval safety data shows significant health risks. The bill requires the FDA to update its advertising regulations within one year of enactment to implement these rules. It applies only to drugs approved under specific FDA pathways after a one-year cutoff before the law's effective date.