s 12 50885 1211342400 false 1211342400 3046 2009 110 300013

5/21/2008--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/>

1211342400 2008-05-21 Fri Nov 07 18:41:43 -0600 2008 introduced 50885 'act':2 'access':1 61041 false short introduced 50885 'act':10 'ill':8 'care':3 'ethic':5 'access':1 'compass':2 'patient':9 'serious':7 61042 false short introduced 50885 'act':11 'ill':33 'new':15 'bill':2 'drug':8,20 'food':7 'need':30 'amend':4 'creat':13 'devic':24 'feder':6 'approv':17 'biolog':21 'condit':16 'cosmet':10 'purpos':38 'system':18 'patient':34 'product':22 'respons':27 'serious':32 60220 false official introduced 50885 1211342400 Wed May 21 00:00:00 -0500 2008 158448 B000953 1956-09-12 4153 303 Hart Senate Office Building http://brownback.senate.gov/public/contact/emailsam.cfm 202-228-1265 Samuel 'r':4 'ks':5 'sam':8 'sen':1 'samuel':2,6,9 'brownback':3,7,10 M 300013 Brownback Sam_Brownback D. Sen. Samuel Brownback [R, KS] 1895 Sam N00005244 10531 Republican 202-224-6521 Roman Catholic KS Sam Samuel Brownback 3.75555555555556 http://brownback.senate.gov/public/ SenatorSamBrownback C001070 5993 393 Russell Senate Office Building http://casey.senate.gov/contact/ 202-228-0604 Robert 'd':4 'pa':5 'sen':1 'casey':3,7,9 'robert':2,6,8 M 412246 Casey Robert_P._Casey,_Jr. P. Sen. Robert Casey [D, PA] 2824 N00027503 13740 Democrat 202-224-6324 PA Bob Robert Casey 2.50877192982456 http://casey.senate.gov/ C001057 1949-08-17 9617 Norm 'norm':1,3,5 'coleman':2,4,6 M 300024 Coleman Norm_Coleman Norm Coleman 3923 N00013870 9268 Republican Jewish Norm Coleman 2.8 I000024 1934-11-17 8282 453 Russell Senate Office Building http://inhofe.senate.gov/public/index.cfm?FuseAction=Contact.ContactForm 202-228-0380 James 'r':4 'ok':5 'jim':8 'sen':1 'jame':2,6,9 'inhof':3,7,10 M 300055 Inhofe James_Inhofe M. Sen. James Inhofe [R, OK] 2870 Jim N00005582 11702 Republican 202-224-4721 Presbyterian OK Jim James Inhofe 4.28395061728395 http://inhofe.senate.gov/public/ JimInhofePressOffice S001141 1946-12-24 3987 335 Russell Senate Office Building http://sessions.senate.gov/public/index.cfm?FuseAction=ConstituentServices.ContactMe 202-224-3149 Jefferson 'r':4 'al':5 'sen':1 'jeff':8 'session':3,7,10 'jefferson':2,6,9 M 300088 Sessions Jeff_Sessions B. Sen. Jefferson Sessions [R, AL] 1719 Jeff N00003062 11510 Republican 202-224-4124 Methodist AL Jeff Jefferson Sessions 3.86363636363636 http://sessions.senate.gov/public/ S000709 1930-02-12 15400 711 Hart Senate Office Building http://specter.senate.gov/public/index.cfm?FuseAction=Contact.ContactForm 202-228-1229 Arlen 'd':4 'pa':5 'sen':1 'arlen':2,6,8 'specter':3,7,9 M 300092 Specter Arlen_Specter Sen. Arlen Specter [D, PA] 6612 N00001604 22100 Democrat 202-224-4254 Jewish PA Arlen Specter 1.81168831168831 http://specter.senate.gov/public/ introduced 50885 1211342400 Wed May 21 00:00:00 -0500 2008 158448 action 50885 1211342400 Wed May 21 00:00:00 -0500 2008 158449 Sponsor introductory remarks on measure. (CR S4625) action 50885 1211342400 Wed May 21 00:00:00 -0500 2008 158450 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.