h 17 51155 1213243200 false 1213675200 6270 1229 110 400423

6/12/2008--Introduced.<br/>Access, Compassion, Care, and Ethics for Seriously Ill Patients Act or the ACCESS Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to permit an investigational drug, biological product, or device to be made available for expanded access under a treatment investigational new drug application or treatment investigational device exemption if specified Compassionate Investigational Access requirements are met.<br/>Gives immunity to the manufacturer, distributor, administrator, sponsor, or physician from suit or liability relating to products approved under this Act. Establishes a procedure for accelerated approval of an investigational drug, biological product, or device that is reasonably likely to predict clinical benefit to a patient suffering from a serious or life-threatening condition.<br/>Requires the Secretary to establish: (1) the Accelerated Approval Advisory Committee; (2) a new program to expand access to investigational treatments for individuals with serious or life threatening conditions and diseases; and (3) a demonstration project under the Medicare program to pay for drugs, biological, products, and devices approved under this Act.<br/>Amends title XVIII (Medicare) of the Social Security Act to revise the definition of &quot;medically accepted indication&quot; to provide for coverage of a covered Part D drug based on the sponsor's or organization's determination that the drug is for a medically accepted indication.<br/>Requires the Secretary to consider the clinical judgment and risks to the patient from the disease or condition in evaluating the safety and effectiveness of drugs, biological products, and devices that treat serious or life-threatening diseases or conditions, including the evaluation of nonstatistical information.<br/>Requires any committee evaluating investigational drugs, devices, or biological product applications to have at least two patient representatives as voting members.<br/>

1213675200 2008-06-17 Fri Nov 07 06:54:23 -0600 2008 introduced 51155 'act':9 'ill':31 'new':13 'drug':6,18 'food':5 'need':28 'amend':2 'creat':11 'devic':22 'feder':4 'approv':15 'biolog':19 'condit':14 'cosmet':8 'purpos':36 'system':16 'patient':32 'product':20 'respons':25 'serious':30 60566 false official introduced 51155 'act':10 'ill':8 'care':3 'ethic':5 'access':1 'compass':2 'patient':9 'serious':7 61092 true popular introduced 51155 'act':2 'access':1 61694 false short introduced 51155 'act':10 'ill':8 'care':3 'ethic':5 'access':1 'compass':2 'patient':9 'serious':7 61695 false short action 51155 1213675200 Tue Jun 17 00:00:00 -0500 2008 169380 Referred to the Subcommittee on Health. W000794 1933-11-12 2413 125 Cannon House Office Building http://www.house.gov/watson/zipauth.shtml 33 202-225-2422 Diane 'd':4 'ca':5 '-33':6 'rep':1 'dian':2,7,9 'watson':3,8,10 F 400423 Watson Diane_E._Watson E. Rep. Diane Watson [D, CA-33] 786 N00013744 6815 Democrat 202-225-7084 Catholic CA Diane Watson 2.0 http://www.house.gov/watson/ B001149 1938-06-21 5312 2308 Rayburn House Office Building http://burton.house.gov/contacts/add/type:contact 5 202-225-0016 Dan 'r':4 '-5':6 'dan':2,7,9 'rep':1 'burton':3,8,10 M 400055 Burton Dan_Burton L. Rep. Dan Burton [R, IN-5] 1879 N00000010 8317 Republican 202-225-2276 Protestant IN Dan Burton 4.0 http://burton.house.gov/ CongressmanDanBurton 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 12957 Democrat 202-225-5126 Baptist MI John Conyers 3.23636363636364 http://www.house.gov/conyers/ C000984 1951-01-18 4058 2235 Rayburn House Office Building https://forms.house.gov/wyr/welcome.shtml 7 202-225-3178 Elijah 'd':4 '-7':6 'md':5 'cum':3,8,10 'rep':1 'elijah':2,7,9 M 400090 Cummings Elijah_E._Cummings Eugene Rep. Elijah Cummings [D, MD-7] 2145 N00001971 7236 Democrat 202-225-4741 Baptist MD Elijah Cummings 4.08333333333333 http://www.house.gov/cummings/ J000032 1950-01-12 4369 2435 Rayburn House Office Building http://www.jacksonlee.house.gov/contact-form.shtml 18 202-225-3317 Sheila 'd':6 'tx':7 '-18':8 'lee':5,12,16 'rep':1 'sheila':2,9,13 'jackson':4,11,15 'jackson-le':3,10,14 F 400199 Jackson-Lee Sheila_Jackson-Lee Rep. Sheila Jackson-Lee [D, TX-18] 1872 N00005818 12536 Democrat 202-225-3816 Seventh Day Adventist TX Sheila Jackson-Lee 1.86046511627907 http://www.jacksonlee.house.gov/ J000126 1935-12-03 1006 1511 Longworth House Office Building http://www.house.gov/ebjohnson/IMA/issue_subscribe.shtml 30 202-226-1477 Eddie 'd':4 'tx':5 '-30':6 'rep':1 'eddi':2,7,9 'johnson':3,8,10 F 400204 Johnson Eddie_Bernice_Johnson Bernice Rep. Eddie Johnson [D, TX-30] 214 N00008122 5673 Democrat 202-225-8885 Baptist TX Eddie Johnson 2.375 http://www.house.gov/ebjohnson/ L000111 1948-07-14 1238 2447 Rayburn House Office Building http://www.tomlatham.house.gov/Contact/ 4 202-225-3301 Thomas 'r':4 '-4':6 'ia':5 'rep':1 'tom':9 'thoma':2,7,10 'latham':3,8,11 M 400234 Latham Tom_Latham P. Rep. Thomas Latham [R, IA-4] 419 Tom N00004227 5320 Republican 202-225-5476 Lutheran IA Tom Thomas Latham http://www.tomlatham.house.gov CongressmanTomLatham S001153 1957-10-20 1983 32 Hilda 'd':4 'ca':5 '-32':6 'rep':1 'soli':3,8,10 'hilda':2,7,9 F 400384 Solis Hilda_L._Solis L. Rep. Hilda Solis [D, CA-32] 946 N00009586 6195 Democrat CA Hilda Solis action 51155 1213675200 Tue Jun 17 00:00:00 -0500 2008 169380 Referred to the Subcommittee on Health. introduced 51155 1213243200 Thu Jun 12 00:00:00 -0500 2008 160203 action 51155 1213243200 Thu Jun 12 00:00:00 -0500 2008 160204 Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, 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. action 51155 1213243200 Thu Jun 12 00:00:00 -0500 2008 160205 Referred to House Energy and Commerce action 51155 1213243200 Thu Jun 12 00:00:00 -0500 2008 160206 Referred to House Ways and Means