3.0.0 870 2019-11-15T21:18:25Z 2019-11-15T21:18:25Z House H HR 2005-02-16 109 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2005-03-14T15:16:52Z Referred to 2005-02-16T15:00:45Z 2005-03-14 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2005-02-16 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2005-02-16 Sponsor introductory remarks on measure. (CR E252) IntroReferral B00100 9 Library of Congress 2005-02-16 Introduced in House IntroReferral Intro-H 9 Library of Congress 2005-02-16 Introduced in House IntroReferral 1000 9 Library of Congress S000810 Rep. Stark, Fortney Pete [D-CA-13] PETE STARK D CA 13 N B000420 Rep. Berry, Marion [D-AR-1] MARION BERRY D AR 1 2005-02-16 True C000984 Rep. Cummings, Elijah E. [D-MD-7] ELIJAH CUMMINGS D MD E. 7 2005-03-02 False I000057 Rep. Israel, Steve [D-NY-2] STEVE ISRAEL D NY 2 2005-03-02 False M000312 Rep. McGovern, James P. [D-MA-3] JAMES MCGOVERN D MA P. 3 2005-03-10 False W000738 Rep. Woolsey, Lynn C. [D-CA-6] LYNN WOOLSEY D CA 6 2005-03-10 False K000336 Rep. Kucinich, Dennis J. [D-OH-10] DENNIS KUCINICH D OH J. 10 2005-03-10 False K000172 Rep. Kildee, Dale E. [D-MI-5] DALE KILDEE D MI E. 5 2005-04-27 False M000404 Rep. McDermott, Jim [D-WA-7] JIM MCDERMOTT D WA 7 2005-04-27 False O000159 Rep. Owens, Major R. [D-NY-11] MAJOR OWENS D NY R. 11 2005-04-27 False J000032 Rep. Jackson-Lee, Sheila [D-TX-18] SHEILA JACKSON-LEE D TX 18 2005-05-12 False S000033 Rep. Sanders, Bernard [I-VT-At Large] Bernard Sanders I VT 0 2005-05-17 False H000627 Rep. Hinchey, Maurice D. [D-NY-22] MAURICE HINCHEY D NY D. 22 2005-06-17 False S001153 Rep. Solis, Hilda L. [D-CA-32] HILDA SOLIS D CA L. 32 2005-12-16 False Health Administrative remedies Business records Chief executive officers Clinical trials Collection of accounts Commerce Corporate accountability Crime and Law Enforcement Department of Health and Human Services Drug approvals Drug industry Drugs Executives Fines (Penalties) Fraud Government Operations and Politics Government paperwork Law Mandatory sentences Pharmaceutical research Product safety Science, Technology, Communications Health 00 2005-02-16 Introduced in House 2005-04-15T18:52:38Z Pharmaceutical Research and Manufacturers Accountability Act of 2005 or the PhRMA Act of 2005 - Sets forth penalties for violations of acts prohibited under the Federal Food, Drug, and Cosmetic Act by an individual employed as the chief executive officer or as a member of the senior executive management group of the manufacturer of a drug, where the violation involves knowing concealment of evidence of a serious adverse drug experience.

Requires the Secretary of Health and Human Services to require the chief executive officer of the manufacturer of a Food and Drug Administration (FDA)-approved drug to annually: (1) attest that the manufacturer has disclosed to the Secretary all evidence of any serious adverse drug experience related to the drug; and (2) describe the process by which the manufacturer ensures that such disclosure has occurred. Allows the Secretary to withdraw an approval for such a drug for failure to provide such an attestation. Prohibits a chief executive officer of a manufacturer of such a drug from failing to provide such an attestation.

Requires the Secretary to direct a manufacturer or sponsor of a drug to complete any required postmarketing study of that drug by a specified deadline. Allows the Secretary to extend such a deadline. Sets forth penalties for failing to meet such a deadline.

]]> PhRMA Act of 2005 Short Titles as Introduced PhRMA Act of 2005 Short Titles as Introduced Pharmaceutical Research and Manufacturers Accountability Act of 2005 Display Title PhRMA Act of 2005 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to provide enhanced criminal penalties for certain violations of the Act involving knowing concealment of evidence of a serious adverse drug experience, and for other purposes. Introduced in House 2005-02-16T05:00:00Z 2005-03-14 Referred to the Subcommittee on Health. 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.