s 32 41211 1171515600 false 1172552400 6 623 583 110 300087

2/15/2007--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.

1172552400 2007-02-27 Fri Nov 07 13:35:27 -0600 2008 introduced 41211 'act':7 'life':4 'save':5 'access':1 'medicin':6 'life-sav':3 44347 short introduced 41211 'act':9 'bill':2 'amend':4 'biolog':19 'compar':16 'health':7 'licens':14 'provid':11 'public':6 'purpos':24 'servic':8 'product':20 'interchang':18 41407 official action 41211 1172552400 Tue Feb 27 00:00:00 -0600 2007 105574 Star Print ordered on S. 623. S000148 1950-11-23 16574 313 Hart Senate Office Building http://schumer.senate.gov/new_website/contact.cfm 202-228-3027 Charles 'd':4 'ny':5 'sen':1 'charl':2,6,8 'schumer':3,7,9 M 300087 Schumer Charles_Schumer E. Sen. Charles Schumer [D, NY] 8308 N00001093 23600 Democrat 202-224-6542 Jewish NY Chuck Charles Schumer 2.01639344262295 http://schumer.senate.gov/ senatorschumer B000944 1952-11-09 9044 713 Hart Senate Office Building http://brown.senate.gov/contact/ 202-228-6321 Sherrod 'd':4 'oh':5 'sen':1 'brown':3,7,9 'sherrod':2,6,8 M 400050 Brown Sherrod_Brown Sen. Sherrod Brown [D, OH] 5679 N00003535 16157 Democrat 202-224-2315 Lutheran OH Sherrod Brown 3.43373493975904 http://brown.senate.gov/ SherrodBrownOhio C001041 1947-10-26 38260 Hillary 'd':4 'ny':5 'sen':1 'clinton':3,7,9 'hillari':2,6,8 F 300022 Clinton Hillary_Clinton Rodham Sen. Hillary Clinton [D, NY] 14835 N00000019 27700 Democrat Methodist NY Hillary Clinton 3.38356164383562 C001057 1949-08-17 9617 Norm 'norm':1,3,5 'coleman':2,4,6 M 300024 Coleman Norm_Coleman Norm Coleman 3923 N00013870 9267 Republican Jewish Norm Coleman 2.8 C001035 1952-12-07 12728 413 Dirksen Senate Office Building http://collins.senate.gov/public/continue.cfm?FuseAction=ContactSenatorCollins.EmailIssue 202-224-2693 Susan 'r':4 'sen':1 'susan':2,6,8 'collin':3,7,9 F 300025 Collins Susan_Collins M. Sen. Susan Collins [R, ME] 6442 N00000491 14461 Republican 202-224-2523 Catholic ME Susan Collins 2.67073170731707 http://collins.senate.gov SenatorSusanCollins L000174 1940-03-31 14079 433 Russell Senate Office Building http://leahy.senate.gov/contact.cfm 202-224-3479 Patrick 'd':4 'vt':5 'sen':1 'leahi':3,7,9 'patrick':2,6,8 M 300065 Leahy Patrick_Leahy J. Sen. Patrick Leahy [D, VT] 7168 N00009918 11683 Democrat 202-224-4242 Roman Catholic VT Patrick Leahy 3.45238095238095 http://leahy.senate.gov/ SenatorPatrickLeahy S000770 1950-04-29 547 133 Hart Senate Office Building http://stabenow.senate.gov/email.cfm 202-228-0325 Debbie Ann 'd':5 'mi':6 'ann':3,8,11 'sen':1 'debbi':2,7,10 'stabenow':4,9,12 F 300093 Stabenow Debbie_Stabenow Sen. Debbie Ann Stabenow [D, MI] 29 N00004118 17007 Democrat 202-224-4822 United Methodist MI Debbie Ann Stabenow 2.31707317073171 http://stabenow.senate.gov/ SenatorStabenow V000127 1961-05-03 10807 516 Hart Senate Office Building http://vitter.senate.gov/public/index.cfm?FuseAction=Contact.ContactForm 202-228-5061 David 'r':4 'la':5 'sen':1 'david':2,6,8 'vitter':3,7,9 M 400418 Vitter David_Vitter Sen. David Vitter [R, LA] 4247 N00009659 11645 Republican 202-224-4623 Catholic LA David Vitter 4.17460317460317 http://vitter.senate.gov/public/ action 41211 1172552400 Tue Feb 27 00:00:00 -0600 2007 105574 Star Print ordered on S. 623. action 41211 1171515600 Thu Feb 15 00:00:00 -0600 2007 105573 Introductory remarks on measure. (CR S2053-2054) introduced 41211 1171515600 Thu Feb 15 00:00:00 -0600 2007 93697 action 41211 1171515600 Thu Feb 15 00:00:00 -0600 2007 115279 Sponsor introductory remarks on measure. (CR S2053-2054) action 41211 1171515600 Thu Feb 15 00:00:00 -0600 2007 93698 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.