PlainBillCongress, translated.Legislation. Context. Public interest.Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Congressional Research Service
Version 00 · Introduced in Senate · May 19, 2004
Direct to Consumer Prescription Drug Advertising Act of 2004 - Requires the Director of the National Institutes of Health to conduct research to compare the effectiveness and safety of prescription drugs covered under Federal Employees Health Benefits Program plans relative to other prescription drugs used to treat the same condition or disease.
Requires the Secretary of Health and Human Services to promulgate amended regulations governing prescription drug advertisements, including to: (1) require such advertisements to present a fair balance between information on the effectiveness of, and side effects or contraindications of, the drug; (2) prohibit false or misleading advertising that would encourage a consumer to take the prescription drug for other than an approved use; and (3) require that all prescription drugs sold to consumers include an explanation of the benefits and risks of use in terms understandable to the general public.
Amends the Federal Food, Drug, and Cosmetic Act to set forth civil penalties for the misbranding of a prescription drug in a direct-to-consumer advertisement if the Secretary provides the person written notice of the violation and the person fails to correct or cease the advertisement to eliminate the violation.
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Requires the Secretary to annually report specified details of all direct-to-consumer advertisements, including those that violate Federal law, and actions taken by the Secretary to respond to such violations.
Requires the Secretary to expedite the review of direct-to-consumer drug advertisements. Prohibits the Secretary from adopting any policy that would delay reviews, except as a result of notice-and-comment rulemaking and as necessary to protect public health and safety.
People & committees
Sen. Edwards, John [D-NC] · D–NC
Legislative record
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Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Primary sources
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Source last updated: Aug 18, 2025. Consult Congress.gov for the current record.
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