3.0.0 6151 2022-02-03T05:08:53Z 2022-02-03T05:08:53Z House H HR 2008-05-22 110 hsif00 Energy and Commerce Committee House Standing Referred to 2008-05-22T14:03:45Z 2008-05-22 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2008-05-22 Introduced in House IntroReferral Intro-H 9 Library of Congress 2008-05-22 Introduced in House IntroReferral 1000 9 Library of Congress D000216 Rep. DeLauro, Rosa L. [D-CT-3] ROSA DELAURO D CT 3 N E000172 Rep. Emerson, Jo Ann [R-MO-8] JO EMERSON R MO ANN 8 2008-05-22 True D000191 Rep. DeFazio, Peter A. [D-OR-4] PETER DEFAZIO D OR A. 4 2008-06-19 False D000399 Rep. Doggett, Lloyd [D-TX-25] LLOYD DOGGETT D TX 25 2008-06-23 False F000116 Rep. Filner, Bob [D-CA-51] BOB FILNER D CA 51 2008-07-23 False L000551 Rep. Lee, Barbara [D-CA-9] BARBARA LEE D CA 9 2008-07-30 False M001143 Rep. McCollum, Betty [D-MN-4] BETTY MCCOLLUM D MN 4 2008-09-10 False L000563 Rep. Lipinski, Daniel [D-IL-3] Daniel Lipinski D IL William 3 2008-09-10 False C000380 Del. Christensen, Donna M. [D-VI-At Large] DONNA CHRISTENSEN D VI M. 0 2008-11-19 False Health Commerce Consumer education Deceptive advertising Drug advertising Drug approvals Drug industry Drugs Fines (Penalties) Government Operations and Politics Government paperwork Governmental investigations Health education Law Public service advertising Sales promotion Science, Technology, Communications Television advertising Health 00 2008-05-22 Introduced in House 2008-08-29T14:32:18Z 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.

]]> Responsibility in Drug and Device Advertising Act of 2008 Short Titles as Introduced Responsibility in Drug and Device Advertising Act of 2008 Display Title Responsibility in Drug and Device Advertising Act of 2008 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act with respect to drug and device advertising, and for other purposes. Introduced in House 2008-05-22T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110hr6151ih/xml/BILLS-110hr6151ih.xml 2008-05-22 Referred to the House Committee on Energy and Commerce. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.