h 7 43657 1178769600 false 1178769600 2273 504 110 400178

5/10/2007--Introduced.<br/>Food and Drug Administration Improvement Act of 2007 - 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.<br/>

1178769600 2007-05-10 Thu Nov 06 21:55:30 -0600 2008 introduced 43657 'act':9,38 'fee':23,59 'use':56,80 'vii':35 'drug':6,30,47,66,82 'food':5,45 'fund':18 'safe':77 'addit':72 'amend':2 'devic':32 'ensur':75 'feder':4 'author':42,73 'center':63 'cosmet':8 'effect':69,79 'negoti':50 'provid':11 'purpos':86 'safeti':67 'termin':40 'chapter':34 'collect':26 'deposit':14 'general':17 'treasuri':21 'administr':48 'establish':61,71 'manufactur':28,53 'particular':55 'postmarket':65 46495 official introduced 43657 'act':6 '2007':8 'drug':3 'food':1 'improv':5 'administr':4 50358 short introduced 43657 1178769600 Thu May 10 00:00:00 -0500 2007 111917 H000627 1938-10-27 3870 2431 Rayburn House Office Building http://www.house.gov/hinchey/contact/zipauth.shtml 22 202-226-0774 Maurice 'd':4 'ny':5 '-22':6 'rep':1 'mauric':2,7,9 'hinchey':3,8,10 M 400178 Hinchey Maurice_D._Hinchey D. Rep. Maurice Hinchey [D, NY-22] 2533 N00001222 7438 Democrat 202-225-6335 Roman Catholic NY Maurice Hinchey 2.11111111111111 http://www.house.gov/hinchey/ G000551 1948-02-19 3572 1440 Longworth House Office Building http://grijalva.house.gov/?sectionid=49&sectiontree=2,49 7 202-225-1541 Raul 'd':4 '-7':6 'az':5 'rep':1 'raul':2,7,9 'grijalva':3,8,10 M 400162 Grijalva M. Rep. Raul Grijalva [D, AZ-7] 1741 N00025284 7443 Democrat 202-225-2435 Roman Catholic AZ Raul Grijalva 3.05882352941176 http://grijalva.house.gov/ S001045 1952-02-29 5878 2352 Rayburn House Office Building http://www.house.gov/stupak/IMA/issue2.htm 1 202-225-4744 Bart 'd':4 '-1':6 'mi':5 'rep':1 'bart':2,7,9 'stupak':3,8,10 M 400391 Stupak Bart_Stupak T. Rep. Bart Stupak [D, MI-1] 3112 N00004196 7672 Democrat 202-225-4735 Catholic MI Bart Stupak 3.63636363636364 http://www.house.gov/stupak BartStupak introduced 43657 1178769600 Thu May 10 00:00:00 -0500 2007 111917 action 43657 1178769600 Thu May 10 00:00:00 -0500 2007 111918 Referred to the House Committee on Energy and Commerce. action 43657 1178769600 Thu May 10 00:00:00 -0500 2007 133213 Referred to the Subcommittee on Health.