3.0.0 2445 2023-01-15T04:49:06Z 2023-01-15T04:49:06Z Senate S S 2004-05-19 108 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2004-05-19T21:00:38Z 2004-05-19 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2004-05-19 Introduced in Senate IntroReferral 10000 9 Library of Congress E000286 Sen. Edwards, John [D-NC] JOHN EDWARDS D NC N Health Administrative procedure Commerce Congress Congressional reporting requirements Consumer education Consumer protection Deceptive advertising Department of Health and Human Services Drug advertising Drug industry Drugs Federal employees Fines (Penalties) Government Operations and Politics Government employees' health insurance Governmental investigations Law Pharmaceutical research Science, Technology, Communications Health 00 2004-05-19 Introduced in Senate 2004-08-05T20:34:53Z Direct to Consumer Prescription Drug Advertising Act of 2004 - Requires the Director of the National Institutes of Health to conduct research to compare the effectiveness and safety of prescription drugs covered under Federal Employees Health Benefits Program plans relative to other prescription drugs used to treat the same condition or disease.

Requires the Secretary of Health and Human Services to promulgate amended regulations governing prescription drug advertisements, including to: (1) require such advertisements to present a fair balance between information on the effectiveness of, and side effects or contraindications of, the drug; (2) prohibit false or misleading advertising that would encourage a consumer to take the prescription drug for other than an approved use; and (3) require that all prescription drugs sold to consumers include an explanation of the benefits and risks of use in terms understandable to the general public.

Amends the Federal Food, Drug, and Cosmetic Act to set forth civil penalties for the misbranding of a prescription drug in a direct-to-consumer advertisement if the Secretary provides the person written notice of the violation and the person fails to correct or cease the advertisement to eliminate the violation.

Requires the Secretary to annually report specified details of all direct-to-consumer advertisements, including those that violate Federal law, and actions taken by the Secretary to respond to such violations.

Requires the Secretary to expedite the review of direct-to-consumer drug advertisements. Prohibits the Secretary from adopting any policy that would delay reviews, except as a result of notice-and-comment rulemaking and as necessary to protect public health and safety.

]]> Direct to Consumer Prescription Drug Advertising Act of 2004 Display Title Direct to Consumer Prescription Drug Advertising Act of 2004 Official Title as Introduced A bill to amend the Federal, Food, Drug, and Cosmetic Act relating to direct-to-consumer prescription drug advertising. Introduced in Senate IS Short Titles as Introduced Direct to Consumer Prescription Drug Advertising Act of 2004 Introduced in Senate 2004-05-19T04:00:00Z 2004-05-19 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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.