Bill > HR4106

This bill, the Responsibility in Drug Advertising Act of 2019, seeks to amend the Federal Food, Drug, and Cosmetic Act to restrict direct-to-consumer drug advertising. The key provisions include: 1. A 3-year ban on direct-to-consumer advertising for any new drug approved by the FDA, with a potential waiver during the third year if the Secretary of Health and Human Services determines the advertising would have a positive public health impact. 2. The ability for the Secretary to prohibit direct-to-consumer advertising of a drug after the initial 3-year period if significant adverse health effects are found based on post-approval studies, risk-benefit analyses, or other scientific evidence. 3. A requirement for the Secretary to revise regulations governing drug advertisements within 1 year to implement these new restrictions on direct-to-consumer advertising. The bill aims to strike a balance between patient information and public health, by limiting the initial promotion of newly approved drugs while preserving the Secretary's authority to further restrict advertising if safety concerns arise.

Business and Industry, Health and Social Services

https://www.congress.gov/bill/116th-congress/house-bill/4106/all-info