3.0.0 1038 2023-01-11T20:03:02Z 2023-01-11T20:03:02Z House H HR 2007-02-14 110 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2007-02-15T15:19:00Z Referred to 2007-02-14T15:02:05Z hsju00 Judiciary Committee House Standing Referred to 2007-02-14T15:02:10Z Access to Life-Saving Medicine Act 110 623 S 2007-02-27 Star Print ordered on S. 623. Identical bill CRS 2007-02-15 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2007-02-14 Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. IntroReferral H11100 2 House floor actions hsju00 Judiciary Committee 2007-02-14 Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. IntroReferral H11100-A 9 Library of Congress 2007-02-14 Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2007-02-14 Introduced in House IntroReferral Intro-H 9 Library of Congress 2007-02-14 Introduced in House IntroReferral 1000 9 Library of Congress W000215 Rep. Waxman, Henry A. [D-CA-30] HENRY WAXMAN D CA A. 30 N E000172 Rep. Emerson, Jo Ann [R-MO-8] JO EMERSON R MO ANN 8 2007-02-14 True P000034 Rep. Pallone, Frank, Jr. [D-NJ-6] FRANK PALLONE D NJ 6 2007-02-14 True E000287 Rep. Emanuel, Rahm [D-IL-5] Rahm Emanuel D IL 5 2007-02-14 True H001042 Rep. Hirono, Mazie K. [D-HI-2] Mazie Hirono D HI K. 2 2007-02-14 True S000810 Rep. Stark, Fortney Pete [D-CA-13] PETE STARK D CA 13 2007-02-16 False K000180 Rep. Kilpatrick, Carolyn C. [D-MI-13] CAROLYN KILPATRICK D MI CHEEKS 13 2007-02-16 False C000714 Rep. Conyers, John, Jr. [D-MI-14] JOHN CONYERS D MI 14 2007-02-27 False A000014 Rep. Abercrombie, Neil [D-HI-1] NEIL ABERCROMBIE D HI 1 2007-02-27 False W000119 Rep. Wamp, Zach [R-TN-3] ZACH WAMP R TN 3 2007-03-06 False G000551 Rep. Grijalva, Raúl M. [D-AZ-7] Raúl Grijalva D AZ M. 7 2007-03-09 False P000099 Rep. Pastor, Ed [D-AZ-4] ED PASTOR D AZ 4 2007-03-20 False T000238 Rep. Thornberry, Mac [R-TX-13] WILLIAM THORNBERRY R TX M. 13 2007-03-26 False N000147 Del. Norton, Eleanor Holmes [D-DC-At Large] ELEANOR NORTON D DC HOLMES 0 2007-03-26 False H000712 Rep. Holden, Tim [D-PA-17] TIM HOLDEN D PA 17 2007-03-26 False C001068 Rep. Cohen, Steve [D-TN-9] Steve Cohen D TN 9 2007-03-26 False H000676 Rep. Hoekstra, Peter [R-MI-2] PETER HOEKSTRA R MI 2 2007-03-28 False W000738 Rep. Woolsey, Lynn C. [D-CA-6] LYNN WOOLSEY D CA 6 2007-03-29 False M001143 Rep. McCollum, Betty [D-MN-4] BETTY MCCOLLUM D MN 4 2007-04-23 False S000480 Rep. Slaughter, Louise McIntosh [D-NY-28] LOUISE SLAUGHTER D NY M. 28 2007-04-25 False L000565 Rep. Loebsack, David [D-IA-2] David Loebsack D IA 2 2007-04-25 False M000309 Rep. McCarthy, Carolyn [D-NY-4] CAROLYN MCCARTHY D NY 4 2007-04-25 False P000585 Rep. Platts, Todd Russell [R-PA-19] TODD PLATTS R PA RUSSELL 19 2007-05-07 False W000672 Rep. Wolf, Frank R. [R-VA-10] FRANK WOLF R VA R. 10 2007-05-17 False A000357 Rep. Allen, Thomas H. [D-ME-1] THOMAS ALLEN D ME H. 1 2007-06-05 False C000754 Rep. Cooper, Jim [D-TN-5] JAMES COOPER D TN H. 5 2007-06-11 False E000288 Rep. Ellison, Keith [D-MN-5] Keith Ellison D MN 5 2007-06-26 False C001049 Rep. Clay, Wm. Lacy [D-MO-1] WM. CLAY D MO LACY 1 2007-07-16 False K000172 Rep. Kildee, Dale E. [D-MI-5] DALE KILDEE D MI E. 5 2007-07-31 False S001175 Rep. Speier, Jackie [D-CA-12] Jackie Speier D CA 12 2008-04-22 False B001245 Del. Bordallo, Madeleine Z. [D-GU-At Large] Madeleine Bordallo D GU Z. 0 2008-06-12 False B001236 Rep. Boozman, John [R-AR-3] John Boozman R AR 3 2008-06-18 False P000583 Rep. Paul, Ron [R-TX-14] RON PAUL R TX 14 2008-06-18 False B001242 Rep. Bishop, Timothy H. [D-NY-1] Timothy Bishop D NY H. 1 2008-07-30 False R000462 Rep. Rothman, Steven R. [D-NJ-9] STEVEN ROTHMAN D NJ R. 9 2008-09-09 False F000043 Rep. Fattah, Chaka [D-PA-2] CHAKA FATTAH D PA 2 2008-09-29 False Health Administrative remedies Civil actions and liability Clinical trials Commerce Congressional reporting requirements Department of Health and Human Services Drug approvals Drug industry Food and Drug Administration (FDA) Government Operations and Politics Injunctions Intellectual property Judicial opinions Judicial review Labeling Law Licenses Patent infringement Patents Pharmaceutical research Product safety Science, Technology, Communications Health 00 2007-02-14 Introduced in House 2007-04-09T20:43:40Z Access to Life-Saving Medicine Act - Amends the Public Health Service Act to establish a process for the approval of an abbreviated biological product application for products that contain the same or similar active ingredients as a previously licensed biological product (the reference product). Allows a person to file an abbreviated biological product application with the Secretary of Health and Human Services that includes: (1) data demonstrating that the product is comparable to or interchangeable with the reference product; (2) information to show that the conditions or conditions of use prescribed, recommended, or suggested in the labeling proposed for the biological product have been previously approved for the reference product; and (3) information to show that the route of administration, the dosage form, and the strength of the biological product are the same as those of the reference product.

Sets forth conditions for approval of such an application by the Secretary.

Allows an applicant to request that the Secretary make a determination as to the interchangeability of a comparable product and the reference product based on whether a product can be expected to produce the same clinical result as the reference product in any given patient. Provides market exclusivity to such an interchangeable product. Requires the Secretary to defer issuing a determination of interchangeability for a subsequent comparable biological product during the period of market exclusivity for a prior interchangeable comparable biological product.

Requires the Secretary to establish requirements for the efficient review, approval, suspension, and revocation of comparable biological product applications.

Sets forth provisions governing patent infringement claims against an applicant or prospective applicant for a comparable biological product license.

]]> Access to Life-Saving Medicine Act Official Title as Introduced To amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products, and for other purposes. Introduced in House IH Display Title Access to Life-Saving Medicine Act Short Titles as Introduced Access to Life-Saving Medicine Act Introduced in House 2007-02-14T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110hr1038ih/xml/BILLS-110hr1038ih.xml 2007-02-15 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.