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Responsibility in Drug and Device Advertising Act of 2008

Introduced: May 22, 2008 Introduced by: DeLauro, Rosa L. Democratic · Connecticut See on congress.gov
 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
May 22, 2008
Referred to the House Committee on Energy and Commerce.
May 22, 2008
Introduced in House
 Plain-English summary Congressional Research Service

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.

What's happening now May 22, 2008

Referred to the House Committee on Energy and Commerce.

 Committees of jurisdiction 1