Direct to Consumer Prescription Drug Advertising Act of 2004

Summary

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. 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.

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Timeline

1. 19 May 2004

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

   Source: IntroReferral

2. 19 May 2004

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 19 May 2004 · Download file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 19 May 2004

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 19 May 2004

  ViewDownloadOpen at official source

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  Vertaal document

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• Introduced in Senate

  summary · EN · 19 May 2004

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Sen. Edwards, John [D-NC] · D · Sponsor
• · sshr00 · Standing

Related records

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