3.0.0 1956 2023-01-11T19:43:32Z 2023-01-11T19:43:32Z House H HR 2007-04-19 110 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2007-04-20T20:07:11Z Referred to 2007-04-19T14:04:50Z 2007-04-20 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2007-04-19 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2007-04-19 Introduced in House IntroReferral Intro-H 9 Library of Congress 2007-04-19 Introduced in House IntroReferral 1000 9 Library of Congress I000026 Rep. Inslee, Jay [D-WA-1] JAY INSLEE D WA 1 N G000410 Rep. Green, Gene [D-TX-29] GENE GREEN D TX 29 2007-04-19 True B001230 Rep. Baldwin, Tammy [D-WI-2] Tammy Baldwin D WI 2 2007-04-19 True T000326 Rep. Towns, Edolphus [D-NY-10] EDOLPHUS TOWNS D NY 10 2007-05-01 False B001251 Rep. Butterfield, G. K. [D-NC-1] G. K. Butterfield D NC 1 2007-05-09 False K000188 Rep. Kind, Ron [D-WI-3] RON KIND D WI 3 2007-05-17 False D000602 Rep. Davis, Artur [D-AL-7] Artur Davis D AL 7 2007-05-17 False S000510 Rep. Smith, Adam [D-WA-9] ADAM SMITH D WA 9 2007-05-17 False T000057 Rep. Tauscher, Ellen O. [D-CA-10] ELLEN TAUSCHER D CA O. 10 2007-05-21 False C001038 Rep. Crowley, Joseph [D-NY-7] JOSEPH CROWLEY D NY 7 2007-05-21 False M001137 Rep. Meeks, Gregory W. [D-NY-6] GREGORY MEEKS D NY W. 6 2007-05-24 False M001161 Rep. Melancon, Charlie [D-LA-3] Charlie Melancon D LA 3 2007-06-25 False B001242 Rep. Bishop, Timothy H. [D-NY-1] Timothy Bishop D NY H. 1 2007-06-28 False M000933 Rep. Moran, James P. [D-VA-8] JAMES MORAN D VA P. 8 2007-07-17 False H000762 Rep. Hooley, Darlene [D-OR-5] DARLENE HOOLEY D OR 5 2007-07-31 False H001030 Rep. Hill, Baron P. [D-IN-9] BARON HILL D IN P. 9 2007-09-25 False R000581 Rep. Richardson, Laura [D-CA-37] Laura Richardson D CA 37 2008-01-29 False C001072 Rep. Carson, Andre [D-IN-7] Andre Carson D IN 7 2008-04-29 False M001168 Rep. Murphy, Patrick J. [D-PA-8] Patrick Murphy D PA J. 8 2008-05-15 False P000583 Rep. Paul, Ron [R-TX-14] RON PAUL R TX 14 2008-06-03 False S001169 Rep. Sestak, Joe [D-PA-7] Joe Sestak D PA 7 2008-06-03 False K000365 Rep. Kagen, Steve [D-WI-8] Steve Kagen D WI 8 2008-07-31 False B001234 Rep. Baca, Joe [D-CA-43] JOE BACA D CA 43 2008-09-09 False H000636 Rep. Hinojosa, Ruben [D-TX-15] RUBEN HINOJOSA D TX 15 2008-09-23 False B001252 Rep. Barrow, John [D-GA-12] John Barrow D GA 12 2008-09-23 False C001065 Rep. Carney, Christopher P. [D-PA-10] Christopher Carney D PA P. 10 2008-09-23 False Health Biotechnology Commerce Congressional reporting requirements Deceptive advertising Drug approvals Drug industry Drugs Federal advisory bodies Government Operations and Politics Labeling Licenses Proteins Science, Technology, Communications Health 00 2007-04-19 Introduced in House 2007-08-01T15:42:18Z Patient Protection and Innovative Biologic Medicines Act of 2007 - Amends the Public Health Service Act to allow any person to submit an application for approval of a biologics license for a biological product that is claimed to be similar to a qualified biological product (reference product) after 12 years have elapsed since the reference product was approved or licensed.

Allows the Secretary of Health and Human Services to approve such a similar biological product: (1) only if the applicant demonstrates that the product conforms to the applicable final product-class specific guidance and the Secretary concludes the product is safe, pure, and potent; (2) only for indications for which the reference product is approved; and (3) to be effective only after at least 14 years have elapsed since the reference product was approved or licensed.

Prohibits the Secretary from designating a similar biological product as therapeutically equivalent to the reference product.

Prohibits the Secretary from approving a product that is claimed to be similar to or the same as a reference product under any other provision of law.

Authorizes any person to request issuance of product-class specific guidance applicable to a qualified biological product and its class.

Requires the Secretary to establish a Similar Biological Products Advisory Committee.

Sets forth provisions governing the naming of biotechnology-derived therapeutic protein and other biological products. Amends the Federal Food, Drug, and Cosmetic Act to deem a biotechnology-derived therapeutic protein to be misbranded if its labeling fails to meet the requirements of this Act.

]]> Patient Protection and Innovative Biologic Medicines Act of 2007 Official Title as Introduced To amend the Public Health Service Act to provide for the approval of similar biological products, and for other purposes. Introduced in House IH Display Title Patient Protection and Innovative Biologic Medicines Act of 2007 Short Titles as Introduced Patient Protection and Innovative Biologic Medicines Act of 2007 Introduced in House 2007-04-19T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110hr1956ih/xml/BILLS-110hr1956ih.xml 2007-04-20 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.