Responsibility in Drug and Device Advertising Act of 2008

Summary

Responsibility in Drug and Device Advertising Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to prohibit direct-to-consumer advertising in the first three years after approval of a new drug or device. Authorizes the Secretary of Health and Human Services to: (1) waive such prohibition if such advertising would have an affirmative value to public health; and (2) continue such prohibition in subsequent years if the drug or device has significant adverse health effects. Requires any direct-to-consumer advertisement to include a fair balance of the benefits and risks associated with the drug or device. Deems a drug to be misbranded if a direct-to-consumer television advertisement for such drug does not prominently display a statement encouraging individuals to report negative side effects of prescription drugs to the Food and Drug Administration (FDA). Requires the Secretary to discontinue the study designed to determine if such a statement is appropriate for television advertisements. Deems a device to be misbranded if a direct-to-consumer television advertisement for such device does not include a statement encouraging individuals to report negative side effects of medical devices to the FDA. Sets forth civil monetary penalties for violations relating to the advertising and promotion of a drug or device. Allows the Secretary to order the distribution of materials to notify the public and the medical community of such a violation and to provide corrective information. Requires the Secretary to conduct an education campaign to increase public awareness of risks that, for some patients, may outweigh the benefits of using a particular drug or device. Authorizes additional appropriations to regulate direct-to-consumer drug and device advertisements.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 22 May 2008

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• Introduced in House (PDF)

  Introduced in House · EN · 22 May 2008

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• Introduced in House

  summary · EN · 22 May 2008

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