H.R. 6151 · 110th Congress
Responsibility in Drug and Device Advertising Act of 2008
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Never voted on. It didn't reach a floor vote before the 110th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
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DeLauroSponsor8 cosponsors · 7 D, 1 R
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Ann Emerson
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DeFazio
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Doggett
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Filner
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Lee
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Lipinski
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McCollum
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Christensen1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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.
What it does: CRS summary · 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.
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Responsibility in Drug and Device Advertising Act of 2008
Latest action (May 22, 2008): Referred to the House Committee on Energy and Commerce.
Policy area: Health · Origin: House · Introduced: May 22, 2008
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.