h 75 41075 1171429200 false 1171515600 2 1038 455 110 400425

2/14/2007--Introduced.<br/>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.

1171515600 2007-02-15 Thu Nov 06 19:07:50 -0600 2008 introduced 41075 'act':7 'amend':2 'biolog':17 'compar':14 'health':5 'licens':12 'provid':9 'public':4 'purpos':22 'servic':6 'product':18 'interchang':16 41261 official action 41075 1171515600 Thu Feb 15 00:00:00 -0600 2007 120977 Referred to the Subcommittee on Health. W000215 1939-09-12 14265 2204 Rayburn House Office Building http://www.house.gov/waxman/contact.htm 30 202-225-4099 Henry 'd':4 'ca':5 '-30':6 'rep':1 'henri':2,7,9 'waxman':3,8,10 M 400425 Waxman Henry_A._Waxman A. Rep. Henry Waxman [D, CA-30] 6541 N00001861 13898 Democrat 202-225-3976 Jewish CA Henry Waxman 1.98823529411765 http://www.house.gov/waxman/ A000014 1938-06-26 4117 1502 Longworth House Office Building http://www.house.gov/abercrombie/e_form.shtml 1 202-225-4580 Neil 'd':4 '-1':6 'hi':5 'rep':1 'neil':2,7,9 'abercrombi':3,8,10 M 400001 Abercrombie Neil_Abercrombie Rep. Neil Abercrombie [D, HI-1] 2217 N00007665 9458 Democrat 202-225-2726 HI Neil Abercrombie 1.5 http://www.house.gov/abercrombie/ A000357 1945-04-16 1281 Thomas 'tom':5 'allen':2,4,7 'thoma':1,3,6 M 400007 Allen Thomas_H._Allen H. Thomas Allen 251 Tom N00000469 5981 Democrat Protestant Thomas Allen B001242 1950-06-01 1112 225 Cannon House Office Building http://timbishop.house.gov/?sectionid=96&sectiontree=7,96 1 202-225-3143 Timothy 'd':4 '-1':6 'ny':5 'rep':1 'bishop':3,8,10 'timothi':2,7,9 M 400031 Bishop Timothy_H._Bishop H. Rep. Timothy Bishop [D, NY-1] 197 N00025413 7287 Democrat 202-225-3826 Roman Catholic NY Timothy Bishop 0.909090909090909 http://www.house.gov/timbishop/ B001236 1950-12-10 3025 1519 Longworth House Office Building https://forms.house.gov/wyr/welcome.shtml 3 202-225-5713 John 'r':4 '-3':6 'ar':5 'rep':1 'john':2,7,9 'boozman':3,8,10 M 400040 Boozman John_Boozman Rep. John Boozman [R, AR-3] 1831 N00013873 7476 Republican 202-225-4301 AR John Boozman 6.23529411764706 http://www.boozman.house.gov/ BoozmanPressOffice B001245 1933-05-31 1011 427 Cannon House Office Building http://www.house.gov/bordallo/IMA/issue.htm 0 202-226-0341 Madeleine 'd':4 '-0':6 'gu':5 'rep':1 'bordallo':3,8,10 'madelein':2,7,9 F 400041 Bordallo Madeleine_Z._Bordallo Rep. Madeleine Bordallo [D, GU-0] 382 N00024866 5902 Democrat 202-225-1188 Catholic GU Madeleine Bordallo 0.571428571428571 http://www.house.gov/bordallo/ C001049 1956-07-27 2247 434 Cannon House Office Building http://lacyclay.house.gov/contact.htm 1 202-226-3717 William 'd':4 '-1':6 'mo':5 'rep':1 'clay':3,8,10 'william':2,7,9 M 400074 Clay William_L_Jr_Clay Lacy Rep. William Clay [D, MO-1] 654 N00012460 6802 Democrat 202-225-2406 Roman Catholic MO Lacy William Clay 1.0 http://lacyclay.house.gov/ CongressmanClay C001068 1949-05-24 5283 1004 Longworth House Office Building http://cohen.house.gov/index.php?option=com_email_form&Itemid=113 9 202-225-5663 Steve 'd':4 '-9':6 'tn':5 'rep':1 'cohen':3,8,10 'steve':2,7,9 M 412236 Cohen Stephen_Cohen Rep. Steve Cohen [D, TN-9] 2039 N00003225 9046 Democrat 202-225-3265 TN Steve Cohen 3.84615384615385 http://www.legislature.state.tn.us/senate/members/s30.htm RepCohen C000714 1929-05-16 15469 2426 Rayburn House Office Building http://conyers.house.gov/index.cfm?FuseAction=Contact.OnlineContactForm 14 202-225-0072 John 'd':4 'mi':5 '-14':6 'rep':1 'john':2,7,9 'conyer':3,8,10 M 400080 Conyers John_Jr.Conyers Rep. John Conyers [D, MI-14] 6145 N00004029 12977 Democrat 202-225-5126 Baptist MI John Conyers 3.23636363636364 http://www.house.gov/conyers/ C000754 1954-06-19 5024 1536 Longworth House Office Building http://www.cooper.house.gov/index.php?option=com_content&task=view&id=117&Itemid=61 5 202-226-1035 Jim 'd':4 '-5':6 'tn':5 'jim':2,7,9 'rep':1 'cooper':3,8,10 M 400081 Cooper Jim_Cooper Rep. Jim Cooper [D, TN-5] 2130 N00003132 7677 Democrat 202-225-4311 Episcopalian TN Jim Cooper 3.63636363636364 http://cooper.house.gov/ RepJimCooper E000288 1963-08-04 7050 1130 Longworth House Office Building http://ellison.house.gov/index.php?option=com_content&task=view&id=87 5 202-225-4886 Keith 'd':4 '-5':6 'mn':5 'rep':1 'keith':2,7,9 'ellison':3,8,10 M 412215 Ellison Keith_Ellison Rep. Keith Ellison [D, MN-5] 2078 N00028257 8985 Democrat 202-225-4755 MN Keith Ellison 6.05882352941176 http://ww3.house.leg.state.mn.us/members/members.asp?district=58B RepKeithEllison E000287 1959-11-29 6712 5 Rahm 'd':4 '-5':6 'il':5 'rep':1 'rahm':2,7,9 'emanuel':3,8,10 M 400120 Emanuel Rahm_Emanuel Rep. Rahm Emanuel [D, IL-5] 2658 N00024813 7504 Democrat Jewish IL Rahm Emanuel 3.0 E000172 1950-09-16 2520 2440 Rayburn House Office Building http://www.house.gov/emerson/contact/ 8 202-226-0326 Jo Ann 'r':5 '-8':7 'jo':2,8,11 'mo':6 'ann':3,9,12 'rep':1 'emerson':4,10,13 F 400121 Emerson Jo_Ann_Emerson H. Rep. Jo Ann Emerson [R, MO-8] 1111 N00005090 7153 Republican 202-225-4404 Presbyterian MO Jo Ann Emerson 4.71428571428571 http://www.house.gov/emerson/ F000043 1956-11-21 2193 2301 Rayburn House Office Building http://fattah.house.gov/?sectionid=8&sectiontree=8 2 202-225-5392 Chaka 'd':4 '-2':6 'pa':5 'rep':1 'chaka':2,7,9 'fattah':3,8,10 M 400130 Fattah Chaka_Fattah Rep. Chaka Fattah [D, PA-2] 1192 N00001746 6426 Democrat 202-225-4001 Baptist PA Chaka Fattah 3.0 http://www.house.gov/fattah/ 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 7438 Democrat 202-225-2435 Roman Catholic AZ Raul Grijalva 3.05882352941176 http://grijalva.house.gov/ H001042 1668 1229 Longworth House Office Building http://hirono.house.gov/IMA/issue_subscribe.htm 2 202-225-4987 Mazie 'd':4 '-2':6 'hi':5 'rep':1 'mazi':2,7,9 'hirono':3,8,10 F 412200 Hirono Mazie_Hirono K. Rep. Mazie Hirono [D, HI-2] 484 N00028139 6362 Democrat 202 225-4906 HI Mazie Hirono http://hirono.house.gov/ H000676 1953-10-30 4740 2234 Rayburn House Office Building http://www.house.gov/formhoekstra/IMA/email.htm 2 202-226-0779 Peter 'r':4 '-2':6 'mi':5 'rep':1 'pete':9 'peter':2,7,10 'hoekstra':3,8,11 M 400182 Hoekstra Peter_Hoekstra Rep. Peter Hoekstra [R, MI-2] 2089 Pete N00004155 6491 Republican 202-225-4401 Reformed Church in America MI Pete Peter Hoekstra 4.75 http://hoekstra.house.gov/ H000712 1957-03-05 2459 2417 Rayburn House Office Building http://www.holden.house.gov/contactform_zipcheck.shtml 17 202-226-0996 Tim 'd':4 'pa':5 '-17':6 'rep':1 'tim':2,7,9 'holden':3,8,10 M 400183 Holden Tim_Holden Rep. Tim Holden [D, PA-17] 856 N00001469 6438 Democrat 202-225-5546 Roman Catholic PA Tim Holden 4.5 http://www.holden.house.gov/ K000172 1929-09-16 1420 2107 Rayburn House Office Building http://www.house.gov/writerep 5 202-225-6393 Dale 'd':4 '-5':6 'mi':5 'rep':1 'dale':2,7,9 'kilde':3,8,10 M 400216 Kildee Dale_E._Kildee E. Rep. Dale Kildee [D, MI-5] 554 N00004070 6769 Democrat 202-225-3611 Roman Catholic MI Dale Kildee 1.41666666666667 http://www.house.gov/kildee/ K000180 1945-06-25 1172 2264 Longworth House Office Building http://www.house.gov/writerep 13 202-225-5730 Carolyn 'd':4 'mi':5 '-13':6 'rep':1 'carolyn':2,7,9 'kilpatrick':3,8,10 F 400217 Kilpatrick Carolyn_C._Kilpatrick Cheeks Rep. Carolyn Kilpatrick [D, MI-13] 271 N00004005 5586 Democrat 202-225-2261 Baptist MI Carolyn Kilpatrick http://www.house.gov/kilpatrick/ L000565 1952-12-23 1176 1513 Longworth House Office Building http://loebsack.house.gov/contactform/ 2 202-226-0757 David 'd':4 '-2':6 'ia':5 'rep':1 'david':2,7,9 'loebsack':3,8,10 M 412209 Loebsack David_Loebsack Rep. David Loebsack [D, IA-2] 137 N00027741 6163 Democrat 202-225-6576 IA David Loebsack 3.66666666666667 http://loebsack.house.gov/ M000309 1944-01-05 3796 106 Cannon House Office Building http://www.house.gov/writerep 4 202-225-5758 Carolyn 'd':4 '-4':6 'ny':5 'rep':1 'carolyn':2,7,9 'mccarthi':3,8,10 F 400257 McCarthy Carolyn_McCarthy Rep. Carolyn McCarthy [D, NY-4] 1313 N00001148 8056 Democrat 202-225-5516 Catholic NY Carolyn McCarthy 0.84 http://carolynmccarthy.house.gov/ M001143 1954-07-12 2743 1714 Longworth House Office Building http://www.mccollum.house.gov/index.asp?Type=NONE&SEC={AC61FD79-AD5F-440D-A7F0-555B12349E5B} 4 202-225-1968 Betty 'd':4 '-4':6 'mn':5 'rep':1 'betti':2,7,9 'mccollum':3,8,10 F 400259 McCollum Betty_McCollum Rep. Betty McCollum [D, MN-4] 1005 N00012942 6646 Democrat 202-225-6631 Roman Catholic MN Betty McCollum 2.5 http://www.mccollum.house.gov/ RepMcCollum N000147 1937-06-13 503 2136 Rayburn House Office Building http://www.norton.house.gov/forms/contact.html 0 202-225-3002 Eleanor 'd':4 '-0':6 'dc':5 'rep':1 'norton':3,8,10 'eleanor':2,7,9 F 400295 Norton Eleanor_Holmes_Norton Holmes Rep. Eleanor Norton [D, DC-0] 106 N00001692 5848 Democrat 202-225-8050 Episcopalian DC Eleanor Norton 5.375 http://www.norton.house.gov/ P000034 1951-10-30 3983 237 Cannon House Office Building http://www.house.gov/pallone/contact.shtml 6 202-225-9665 Frank 'd':4 '-6':6 'nj':5 'rep':1 'frank':2,7,9 'pallon':3,8,10 M 400308 Pallone Frank_Jr.Pallone J. Rep. Frank Pallone [D, NJ-6] 2273 N00000781 6727 Democrat 202-225-4671 Catholic NJ Frank Pallone 3.41666666666667 http://www.house.gov/pallone/ P000099 1943-06-28 964 2465 Rayburn House Office Building http://www.house.gov/writerep 4 202-225-1655 Edward 'd':4 '-4':6 'az':5 'ed':9 'rep':1 'edward':2,7,10 'pastor':3,8,11 M 400310 Pastor Ed_Pastor Rep. Edward Pastor [D, AZ-4] 207 Ed N00006397 5751 Democrat 202-225-4065 Roman Catholic AZ Edward Pastor 0.363636363636364 http://www.pastor.house.gov/ P000583 1935-08-20 6060 203 Cannon House Office Building http://www.house.gov/paul/contact.shtml 14 202-226-6553 Ronald 'r':4 'tx':5 '-14':6 'rep':1 'ron':9 'paul':3,8,11 'ronald':2,7,10 M 400311 Paul Ron_Paul E. Rep. Ronald Paul [R, TX-14] 1898 Ron N00005906 46772 Republican 202-225-2831 Protestant TX Ron Ronald Paul 9.39819004524887 http://www.house.gov/paul/ congressmanronpaul P000585 1962-03-05 1549 1032 Longworth House Office Building http://www.house.gov/platts/email.shtml 19 202-226-1000 Todd 'r':4 'pa':5 '-19':6 'rep':1 'todd':2,7,9 'platt':3,8,10 M 400321 Platts Todd_Russell_Platts R. Rep. Todd Platts [R, PA-19] 585 N00009719 6469 Republican 202-225-5836 Episcopalian PA Todd Platts 5.76923076923077 http://www.house.gov/platts/ R000462 1952-10-14 1363 2303 Rayburn House Office Building https://forms.house.gov/rothman/webforms/issue_subscribe.htm 9 202-225-5851 Steven 'd':4 '-9':6 'nj':5 'rep':1 'steven':2,7,9 'rothman':3,8,10 M 400346 Rothman Steven_R._Rothman R. Rep. Steven Rothman [D, NJ-9] 368 N00008619 6016 Democrat 202-225-5061 Jewish NJ Steve Steven Rothman http://www.house.gov/rothman/ S000480 1929-08-14 3901 2469 Rayburn House Office Building http://www.louise.house.gov/index.php?option=com_content&task=view&id=506&Itemid=150 28 202-225-7822 Louise 'd':4 'ny':5 '-28':6 'rep':1 'louis':2,7,9 'slaughter':3,8,10 F 400378 Slaughter Louise_McIntosh_Slaughter McIntosh Rep. Louise Slaughter [D, NY-28] 1908 N00001311 9733 Democrat 202-225-3615 Episcopalian NY Louise Slaughter 1.75 http://www.louise.house.gov louiseslaughter S001175 1950-05-14 1923 2413 Rayburn House Office Building http://speier.house.gov/IMA/issue_subscribe.htm 12 202-347-0956 Jackie 'd':4 'ca':5 '-12':6 'rep':1 'jacki':2,7,9 'speier':3,8,10 F 412259 Speier Jackie_Speier Rep. Jackie Speier [D, CA-12] 662 N00029649 2928 Democrat 202-225-3531 CA Jackie Jackie Speier 5.0 http://speier.house.gov/index.shtml S000810 1931-11-11 2046 239 Cannon House Office Building http://www.house.gov/stark/contact/index.htm 13 202-226-3805 Fortney 'd':4 'ca':5 '-13':6 'rep':1 'pete':9 'stark':3,8,11 'fortney':2,7,10 M 400387 Stark Fortney_Pete_Stark H. Rep. Fortney Stark [D, CA-13] 618 Pete N00007397 6677 Democrat 202-225-5065 Unitarian CA Pete Fortney Stark 3.85714285714286 http://www.house.gov/stark/ repstark T000238 1958-07-15 744 2457 Rayburn House Office Building http://www.house.gov/writerep 13 202-225-3486 William 'r':4 'tx':5 '-13':6 'mac':9 'rep':1 'william':2,7,10 'thornberri':3,8,11 M 400404 Thornberry Mac_Thornberry M. Rep. William Thornberry [R, TX-13] 215 Mac N00006052 4920 Republican 202-225-3706 Presbyterian TX Mac William Thornberry 6.5 http://www.house.gov/thornberry/ W000119 1957-10-28 2988 1436 Longworth House Office Building http://www.house.gov/wamp/contact_email.shtm 3 202-225-3494 Zach 'r':4 '-3':6 'tn':5 'rep':1 'wamp':3,8,10 'zach':2,7,9 M 400421 Wamp Zach_Wamp Rep. Zach Wamp [R, TN-3] 1836 N00003159 6521 Republican 202-225-3271 Baptist TN Zach Wamp 4.1 http://www.house.gov/wamp/ W000672 1939-01-30 4459 241 Cannon House Office Building http://www.house.gov/formwolf/contact_email/emailzip.shtml 10 202-225-0437 Frank 'r':4 'va':5 '-10':6 'rep':1 'wolf':3,8,10 'frank':2,7,9 M 400435 Wolf Frank_R._Wolf Rudolph Rep. Frank Wolf [R, VA-10] 1877 N00002073 6939 Republican 202-225-5136 Presbyterian VA Frank Wolf 6.54545454545455 http://www.house.gov/wolf/ RepFrankWolf W000738 1937-11-03 4272 2263 Rayburn House Office Building http://woolsey.house.gov/contactemailform.asp 6 202-225-5163 Lynn 'd':4 '-6':6 'ca':5 'rep':1 'lynn':2,7,9 'woolsey':3,8,10 F 400436 Woolsey Lynn_C._Woolsey C. Rep. Lynn Woolsey [D, CA-6] 1710 N00007458 7606 Democrat 202-225-5161 Presbyterian CA Lynn Woolsey 3.2 http://woolsey.house.gov/ action 41075 1171515600 Thu Feb 15 00:00:00 -0600 2007 120977 Referred to the Subcommittee on Health. action 41075 1171429200 Wed Feb 14 00:00:00 -0600 2007 105387 Referred to House Energy and Commerce action 41075 1171429200 Wed Feb 14 00:00:00 -0600 2007 105386 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. introduced 41075 1171429200 Wed Feb 14 00:00:00 -0600 2007 93342 action 41075 1171429200 Wed Feb 14 00:00:00 -0600 2007 93343 Referred to House Judiciary