3.0.0 2090 2021-09-29T20:23:41Z 2021-09-29T20:23:41Z House H HR 2005-05-04 109 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2005-05-23T15:27:26Z Referred to 2005-05-04T14:02:15Z 2006-06-21 Sponsor introductory remarks on measure. (CR H4358-4359) IntroReferral B00100 9 Library of Congress 2005-05-23 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2005-05-04 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2005-05-04 Introduced in House IntroReferral Intro-H 9 Library of Congress 2005-05-04 Introduced in House IntroReferral 1000 9 Library of Congress H000627 Rep. Hinchey, Maurice D. [D-NY-22] MAURICE HINCHEY D NY D. 22 N D000216 Rep. DeLauro, Rosa L. [D-CT-3] ROSA DELAURO D CT 3 2005-05-04 True S001045 Rep. Stupak, Bart [D-MI-1] BART STUPAK D MI 1 2005-05-04 True G000551 Rep. Grijalva, Raúl M. [D-AZ-7] Raúl Grijalva D AZ M. 7 2005-06-14 False W000738 Rep. Woolsey, Lynn C. [D-CA-6] LYNN WOOLSEY D CA 6 2005-06-14 False C001055 Rep. Case, Ed [D-HI-2] Ed Case D HI 2 2005-07-25 False L000562 Rep. Lynch, Stephen F. [D-MA-9] Stephen Lynch D MA F. 9 2005-11-18 False E000250 Rep. Evans, Lane [D-IL-17] LANE EVANS D IL 17 2005-11-18 False F000043 Rep. Fattah, Chaka [D-PA-2] CHAKA FATTAH D PA 2 2005-12-07 False M000590 Rep. McNulty, Michael R. [D-NY-21] MICHAEL MCNULTY D NY R. 21 2005-12-07 False S000033 Rep. Sanders, Bernard [I-VT-At Large] Bernard Sanders I VT 0 2005-12-07 False W000314 Rep. Wexler, Robert [D-FL-19] ROBERT WEXLER D FL 19 2005-12-16 False C000714 Rep. Conyers, John, Jr. [D-MI-14] JOHN CONYERS D MI 14 2005-12-16 False K000336 Rep. Kucinich, Dennis J. [D-OH-10] DENNIS KUCINICH D OH J. 10 2005-12-16 False M000312 Rep. McGovern, James P. [D-MA-3] JAMES MCGOVERN D MA P. 3 2006-07-20 False J000283 Rep. Jackson, Jesse L., Jr. [D-IL-2] JESSE JACKSON D IL L. 2 2006-07-20 False Health Administrative fees Animals Clinical trials Commerce Communication in medicine Conflict of interests Consumer education Consumer protection Data banks Department of Health and Human Services Drug advertising Drug approvals Drug industry Drugs Economics and Public Finance Executive reorganization Federal advisory bodies Federal-state relations Fines (Penalties) Food and Drug Administration (FDA) Government Operations and Politics Government and business Government ethics Government publicity Health education Health information systems Informed consent (Medical law) Labeling Law Medical ethics Medical research Medical supplies Parties to actions Physicians Product safety Products liability Science, Technology, Communications State courts State laws Veterinary medicine Warning labels Health 00 2005-05-04 Introduced in House 2005-06-16T18:20:44Z Food and Drug Administration Improvement Act of 2005 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require that all fees collected for the review of applications for human drugs, devices, and animal drugs be deposited in the general fund of the Treasury. Makes available amounts necessary for the Secretary of Health and Human Services to review such applications.

Prohibits the Secretary from entering into agreements with persons from whom such fees are collected and terminates any existing agreements.

Requires the Secretary to: (1) establish the Center for Postmarket Drug Safety and Effectiveness within the Food and Drug Administration (FDA) to regulate approved drugs; and (2) transfer to the Center all responsibilities for such regulation from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.

Allows the Secretary to require manufacturers of approved drugs to conduct studies of an identified significant safety issue with the drug.

Deems a drug to be misbranded if it does not meet the Secretary's requirements, including requirements for labeling and conducting postmarket studies.

Requires the Secretary to follow the interpretation that the FDA used in 1999 that the FFDCA and Public Health Service Act establish minimal standards but do not preclude additional state requirements. Requires the Secretary to cease intervening in product liability civil actions to argue another interpretation.

Sets forth procedures for advisory committee meetings to ensure that the committee is fairly balanced. Prohibits any exemptions from being granted to advisory committee members from rules prohibiting members from having a personal financial interest in the outcome.

Requires doctors to inform patients and obtain consent to prescribe an approved drug for a purpose that has not been approved by the FDA.

]]> Food and Drug Administration Improvement Act of 2005 Short Titles as Introduced Food and Drug Administration Improvement Act of 2005 Display Title Food and Drug Administration Improvement Act of 2005 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to provide for the deposit in the general fund of the Treasury of fees that are collected from manufacturers of drugs and devices under chapter VII of such Act, to terminate the authority of the Food and Drug Administration to negotiate with the manufacturers on particular uses of the fees, to establish a Center for Postmarket Drug Safety and Effectiveness, to establish additional authorities to ensure the safe and effective use of drugs, and for other purposes. Introduced in House 2005-05-04T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-109hr2090ih/xml/BILLS-109hr2090ih.xml 2006-06-21 Sponsor introductory remarks on measure. (CR H4358-4359) 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.