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3/11/2009--Introduced.Promoting Innovation and Access to Life-Saving Medicine Act - Amends the Public Health Service Act to provide for the licensing of biosimilar and interchangeable biological products. Defines "biosimilar" and "interchangeability" for purposes of this Act. Allows any person to file an abbreviated biological product application with the Secretary of Health and Human Services. Requires such applications to include information demonstrating a high degree of similarity or interchangeability between the biological product and the licensed biological product (reference product). Requires the Secretary to: (1) approve an application and issue a license for a biosimilar product unless the Secretary finds and informs the applicant that the information in the application fails to demonstrate biosimilarity between the biological product and the reference product or the safety, purity, and potency of the biological product; and (2) establish requirements for the efficient review, approval, suspension, and revocation of abbreviated biological product applications. Allows an applicant to request the Secretary to make a determination as to the interchangeability of a product and its reference product based on whether a product can be expected to produce the same clinical result as the reference product in any given patient. Grants market exclusivity to any biological product that is determined to be interchangeable for a specified period. Sets forth provisions governing patent infringement claims involving comparable biological products and legal remedies to expedite the adjudication of patent infringement disputes. Extends the period for approval of biological products to allow for studies of the use of new biological products in the pediatric population.

1236744000 2009-03-11 Fri Oct 16 07:26:38 -0500 2009 introduced 55774 'act':7 'amend':2 'biolog':17 'health':5 'licens':12 'provid':9 'public':4 'purpos':22 'servic':6 'product':18 'biogener':16 'biosimilar':14 70115 false official introduced 55774 'act':10 'life':7 'save':8 'innov':2 'access':4 'promot':1 'medicin':9 'life-sav':6 70114 false short action 55774 1236744000 Wed Mar 11 00:00:00 -0500 2009 187417 Referred to House Judiciary W000215 1939-09-12 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] N00001861 13501 Democrat 202-225-3976 Jewish CA Henry Waxman 1.78481012658228 http://www.house.gov/waxman/ A000363 327 Cannon House Office Building http://arcuri.house.gov/IMA/issue_subscribe.htm 24 202-225-1891 Michael 'd':4 'ny':5 '-24':6 'rep':1 'arcuri':3,8,10 'michael':2,7,9 M 412224 Arcuri Michael_Arcuri A. Rep. Michael Arcuri [D, NY-24] N00027890 7980 Democrat 202-225-3665 NY Michael Arcuri 3.85714285714286 http://arcuri.house.gov/index.shtml C001036 1938-01-10 1110 Longworth House Office Building http://www.house.gov/capps/contact/send_an_email.shtml 23 202-225-5632 Lois 'd':4 'ca':5 '-23':6 'loi':2,7,9 'rep':1 'capp':3,8,10 F 400062 Capps Lois_Capps Rep. Lois Capps [D, CA-23] N00007232 7078 Democrat 202-225-3601 Lutheran CA Lois Capps 4.44444444444444 http://www.house.gov/capps/ C000714 1929-05-16 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] N00004029 12683 Democrat 202-225-5126 Baptist MI John Conyers 3.2962962962963 http://www.house.gov/conyers/ D000168 1942-08-25 2133 Rayburn House Office Building http://www.house.gov/deal/contact/default.shtml 9 202-225-8272 Nathan 'r':4 '-9':6 'ga':5 'rep':1 'deal':3,8,10 'nathan':2,7,9 M 400099 Deal Nathan_Deal Rep. Nathan Deal [R, GA-9] N00002610 6317 Republican 202-225-5211 Baptist GA Nathan Deal 6.1 http://www.house.gov/deal/ E000172 1950-09-16 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] N00005090 6960 Republican 202-225-4404 Presbyterian MO Jo Ann Emerson 4.71428571428571 http://www.house.gov/emerson/ G000551 1948-02-19 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] N00025284 7272 Democrat 202-225-2435 Roman Catholic AZ Raul Grijalva 3.46666666666667 http://grijalva.house.gov/ H001047 1966-07-05 214 Cannon House Office Building https://forms.house.gov/himes/contact-form.shtml 4 202-225-9629 James 'd':4 '-4':6 'ct':5 'rep':1 'hime':3,8,10 'jame':2,7,9 M 412282 Himes A. Rep. James Himes [D, CT-4] N00029070 2854 Democrat 202-225-5541 CT James Himes 5.0 http://himes.house.gov/ K000009 1946-06-17 2186 Rayburn House Office Building http://www.kaptur.house.gov/index.php?option=com_content&task=view&id=152 9 202-225-7711 Marcy 'd':4 '-9':6 'oh':5 'rep':1 'marci':2,7,9 'kaptur':3,8,10 F 400211 Kaptur Marcy_Kaptur Rep. Marcy Kaptur [D, OH-9] N00003522 8419 Democrat 202-225-4146 Roman Catholic OH Marcy Kaptur 4.52941176470588 http://www.kaptur.house.gov/ K000220 1955-04-24 2368 Rayburn House Office Building http://kingston.house.gov/ContactForm/ 1 202-226-2269 Jack 'r':4 '-1':6 'ga':5 'rep':1 'jack':2,7,9 'kingston':3,8,10 M 400221 Kingston Jack_Kingston Rep. Jack Kingston [R, GA-1] N00002656 6196 Republican 202-225-5831 Episcopalian GA Jack Kingston 8.4 http://kingston.house.gov/ JackKingston L000321 1942-09-09 1026 Longworth House Office Building http://linder.house.gov/index.cfm?FuseAction=ContactJohn.ContactForm 7 202-225-4696 John 'r':4 '-7':6 'ga':5 'rep':1 'john':2,7,9 'linder':3,8,10 M 400242 Linder John_Linder Rep. John Linder [R, GA-7] N00002599 7144 Republican 202-225-4272 Presbyterian GA John Linder 6.52173913043478 http://linder.house.gov/ P000034 1951-10-30 237 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] N00000781 6558 Democrat 202-225-4671 Catholic NJ Frank Pallone 2.81818181818182 http://www.house.gov/pallone/ P000583 1935-08-20 203 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] Ron N00005906 45844 Republican 202-225-2831 Protestant TX Ron Ronald Paul 9.40092699884125 http://www.house.gov/paul/ congressmanronpaul S001168 1962-05-22 426 Cannon House Office Building http://sarbanes.house.gov/federal.asp 3 202-225-9219 John 'd':4 '-3':6 'md':5 'rep':1 'john':2,7,9 'sarban':3,8,10 M 412212 Sarbanes John_Sarbanes P. Rep. John Sarbanes [D, MD-3] N00027751 6824 Democrat 202-225-4016 MD John Sarbanes 1.22222222222222 http://sarbanes.house.gov/ S001145 1944-05-26 1027 Longworth House Office Building http://www.house.gov/schakowsky/contact.shtml 9 202-226-6890 Janice 'd':4 '-9':6 'il':5 'jan':9 'rep':1 'janic':2,7,10 'schakowski':3,8,11 F 400360 Schakowsky Janice_D._Schakowsky D. Rep. Janice Schakowsky [D, IL-9] Jan N00004724 7667 Democrat 202-225-2111 Jewish IL Jan Janice Schakowsky 2.81818181818182 http://www.house.gov/schakowsky JanSchakowsky T000238 1958-07-15 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] Mac N00006052 4824 Republican 202-225-3706 Presbyterian TX Mac William Thornberry 6.5 http://www.house.gov/thornberry/ W000672 1939-01-30 241 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] N00002073 6794 Republican 202-225-5136 Presbyterian VA Frank Wolf 6.54545454545455 http://www.house.gov/wolf/ RepFrankWolf Y000033 1933-06-09 2111 Rayburn House Office Building http://donyoung.house.gov/IMA/issue_subscribe.htm 0 202-225-0425 Donald 'r':4 '-0':6 'ak':5 'rep':1 'young':3,8,11 'donald':2,7,10 M 400440 Young Don_Young E. Rep. Donald Young [R, AK-0] Don N00007999 7673 Republican 202-225-5765 Episcopalian AK Don Donald Young 5.14285714285714 http://donyoung.house.gov/ RepDonYoung action 55774 1236744000 Wed Mar 11 00:00:00 -0500 2009 187417 Referred to House Judiciary action 55774 1236744000 Wed Mar 11 00:00:00 -0500 2009 187416 Referred to House Energy and Commerce action 55774 1236744000 Wed Mar 11 00:00:00 -0500 2009 187415 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 55774 1236744000 Wed Mar 11 00:00:00 -0500 2009 187414