Responsibility in Drug and Device Advertising Act of 2008

To amend the Federal Food, Drug, and Cosmetic Act with respect to drug and device advertising, and for other purposes.

5/22/2008--Introduced.
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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Sponsor

• Rep. Rosa DeLauro [D, CT-3]
• and 7 Co-Sponsors
  • Rep. Peter DeFazio [D, OR-4]
  • Rep. Lloyd Doggett [D, TX-25]
  • Rep. Jo Ann Emerson [R, MO-8]
  • Rep. Bob Filner [D, CA-51]
  • Rep. Barbara Lee [D, CA-9]
  • Rep. Daniel Lipinski [D, IL-3]
  • Rep. Betty McCollum [D, MN-4]
  close

Committees

• House Energy and Commerce

Amendments

This bill has no amendments.

Amendments to H.R.6151

Number	Status	Purpose

Bill Status

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Introduced		Voted on by House		Voted on by Senate		Considered By President		Bill Becomes Law
May 22, 2008

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All Bill Actions

• May 22, 2008: Referred to the House Committee on Energy and Commerce.
• Introduced on May 22, 2008.

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Blog Coverage

July 17, 2008 Advertising Moratorium Suggested

... chairwoman of the Drug Administration Appropriations Subcommittee, and Jo Ann Emerson of Missouri introduced the Responsibility in Drug and Device Advertising Act of 2008 (HR 6151), to the House of Representatives in May, 2008. ...

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Source: The Media Professional

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June 02, 2008 Congress should strengthen regulations on direct-to-consumer ...

DeLauro sponsored HR 6151 to impose restrictions on drug ads.

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Source: Rosa DeLauro - whereIstand.com

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June 02, 2008 Congress should strengthen regulations on direct-to-consumer ...

DeLauro sponsored HR 6151 to impose restrictions on drug ads.

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Source: Rosa DeLauro - whereIstand.com

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