Responsibility in Drug Advertising Act of 2005

Summary

Responsibility in Drug Advertising Act of 2005 - Amends the Federal Food, Drug, and Cosmetic Act to prohibit any person from conducting direct-to-consumer advertising of a prescription drug for three years after approval of such drug. Allows the Secretary of Health and Human Services to: (1) waive such prohibition if such advertising will have an affirmative value to public health; or (2) extend such prohibition for subsequent years if the drug has significant adverse effects. Provides for civil penalties for violations relating to prescription drug advertisement or promotion. Allows the Secretary to require distribution of corrective information to notify the public and medical community of the violation. Allows the Secretary to: (1) require information to be included in the labeling of a drug if such information is necessary to ensure the safe and effective use of the drug; and (2) require the manufacturer of a drug to notify the public and the medical community of the labeling change. Deems a drug to be misbranded if such labeling or notification requirements are not met. Requires the Secretary to conduct an education campaign to increase public awareness of risks that may outweigh the benefits of using a particular drug, whether such risks are known at the time of the approval of the drug or become known later.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 29 September 2005

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• Introduced in House (PDF)

  Introduced in House · EN · 29 September 2005

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• Introduced in House

  summary · EN · 29 September 2005

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