U.S. Congress - H.R.6151 Responsibility in Drug and Device Advertising Act of 2008
H.R.6151 - 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. view all titles (2)
All Bill Titles
- Short: Responsibility in Drug and Device Advertising Act of 2008 as introduced.
- Official: To amend the Federal Food, Drug, and Cosmetic Act with respect to drug and device advertising, and for other purposes. as introduced.
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Official Summary
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 ServiceOfficial Summary
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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Recent Blog Coverage
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Iâm Not Into Perscription Drug Ads « The Day After An Inconvenient ...
This petition is about getting Congress to support H.R. 6151, The Responsibility in Drug and Device Advertising Act of 2008, a bill introduced by Representatives DeLauro and Emerson that would place a three-year moratorium on ...
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. ...
legislative updates
the responsibility in drug and device advertising act of 2008 (hr 6151) would impose a three-year moratorium on dtc ads and give the fda authority to require companies to distribute "corrective materials" if they violate the moratorium. ...
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