summary
Introduced
02/07/2025
02/07/2025
In Committee
02/07/2025
02/07/2025
Crossed Over
Passed
Dead
Introduced Session
119th Congress
Bill Summary
A BILL To amend the Federal Food, Drug, and Cosmetic Act to restrict direct-to-consumer drug advertising.
AI Summary
This bill aims to regulate direct-to-consumer drug advertising by introducing new restrictions on how and when pharmaceutical companies can advertise newly approved prescription drugs. Specifically, the bill prohibits drug companies from conducting direct-to-consumer advertising (including on social media) for any new drug during its first three years on the market. After the initial three-year period, the Secretary of Health and Human Services can grant a waiver to allow advertising if the drug sponsor demonstrates that such advertising would have a positive public health value. Additionally, the Secretary retains the authority to prohibit advertising beyond the three-year mark if post-approval studies, risk-benefit analyses, or adverse event reports indicate significant health risks associated with the drug. The bill requires the Secretary to revise existing drug advertisement regulations within one year of enactment and applies to drugs approved one year prior to or after the bill's enactment. The goal is to protect consumers by allowing more time to understand a new drug's safety and effectiveness before widespread marketing begins, while maintaining flexibility for drugs that demonstrably benefit public health.
Committee Categories
Business and Industry
Sponsors (1)
Last Action
Referred to the House Committee on Energy and Commerce. (on 02/07/2025)
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location |
|---|---|
| State Bill Page | https://www.congress.gov/bill/119th-congress/house-bill/1117/all-info |
| BillText | https://www.congress.gov/119/bills/hr1117/BILLS-119hr1117ih.pdf |
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