Bill > S483

This bill, known as the Responsibility in Drug Advertising Act of 2025, aims to restrict direct-to-consumer drug advertising by pharmaceutical companies. The bill amends the Federal Food, Drug, and Cosmetic Act to prohibit advertising of newly approved drugs for the first three years after their approval. During this initial period, drug manufacturers cannot conduct advertisements through traditional or social media platforms. However, the Secretary of Health and Human Services can grant a waiver during the third year if the drug sponsor can demonstrate that the advertising would provide a public health benefit. After the three-year period, the Secretary retains the authority to prohibit advertising for a drug if post-approval studies, risk-benefit analyses, or adverse event reports indicate significant health risks. The bill requires the Secretary to revise existing drug advertisement regulations within one year of enactment and explicitly states that this new provision does not limit the Secretary's existing authority to regulate drug advertising. The new rules would apply to drugs approved one year before the bill's enactment date, giving regulatory agencies and pharmaceutical companies time to prepare for the new restrictions.

Health and Social Services

https://www.congress.gov/bill/119th-congress/senate-bill/483/all-info