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This bill amends the Federal Food, Drug, and Cosmetic Act to restrict direct-to-consumer drug advertising. It prohibits such advertising for newly approved drugs for the first three years, with a possible waiver in the third year, and allows the Secretary to extend the ban if the drug has significant adverse health effects.
Sec. 2, Direct-to-consumer drug advertising: The bill adds a new section 506M to the Act. It bans direct-to-consumer advertising, including on social media, for any drug approved under section 505(c) for the first three years after approval. The Secretary may waive this ban during the third year if the drug sponsor applies and the Secretary finds the advertising would have affirmative public health value. After three years, the Secretary may prohibit advertising if the drug has significant adverse health effects based on post-approval studies, risk-benefit analyses, adverse event reports, scientific literature, or other resources. The Secretary must revise regulations within one year to implement this section. The section does not limit the Secretary's existing authority to regulate drug advertising. It applies to drugs approved on or after one year before the bill's enactment.
Summary of the bill text as introduced in Senate (Jul 25, 2024), generated by SecBot from the official bill text; the Library of Congress summary is not yet published.
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Official record from Congress.gov, the House Clerk and the Senate; lobbying from Lobbying Disclosure Act filings. Updated Oct 28, 2026.