PlainBillCongress, translated.Legislation. Context. Public interest.Referred to the House Committee on Energy and Commerce.
Congressional Research Service
Version 00 · Introduced in House · May 22, 2008
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.
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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.
People & committees
Rep. DeLauro, Rosa L. [D-CT-3] · D–CT
Legislative record
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Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
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Source last updated: Aug 14, 2025. Consult Congress.gov for the current record.
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