,,ii #aai? ,,congress #b;d ,session ,s4 #dfih ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,june #h1 #bjbf,mr4 ,johnson 7= himself & ,mr4 ,tub]ville7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to au?orize ! use ( inve/igational individualiz$ m$ical treatm5ts by pati5ts diagnos$ ) a life-?reat5+ disease or condition or sev]ely debilitat+ illness1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,"r to ,try = ,individualiz$ ,treatm5ts ,act4 #b4 ,use ( inve/igational individualiz$ m$ical treatm5ts by pati5ts diagnos$ ) a life-?reat5+ disease or condition or sev]ely debilitat+ illness 7a7 ,def9itions ,section #efa;,b7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#j;a7a77 is am5d$-- 7#a7 by am5d+ p>agraph 7#a7 to read z foll[s3 7#a7 ! t]m eligible pati5t means-- 7,a7 9 ! case ( a pati5t reque/+ an eligible inve/igational drug1 a pati5t :o has-- 7i7 be5 diagnos$ ) a life-?reat5+ disease or condition 7z def9$ 9 section #cab4ha ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 7ii7 exhau/$ approv$ treatm5t options & is unable to p>ticipate 9 a cl9ical trial involv+ ! eligible inve/igational drug1 z c]tifi$ by a physician1 :o-- 7,i7 is 9 good /&+ ) ! physician's lic5s+ organization or bo>d2 & 7,,ii7 w n be comp5sat$ directly by ! manufactur] ( su* drug = s c]tify+2 & 7iii7 provid$ to ! treat+ physician writt5 in=m$ cons5t reg>d+ ! eligible inve/igational drug1 or1 z applicable1 on ^: behalf a legally au?oriz$ repres5tative ( ! pati5t has provid$ su* cons5t2 or 7,b7 9 ! case ( a pati5t reque/+ an inve/igational individualiz$ m$ical treatm5t1 a pati5t :o has-- 7i7 be5 diagnos$ ) a life-?reat5+ disease or condition or sev]ely debilitat+ illness 7z su* t]ms are def9$ 9 section #cab4ha ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 7ii7 consid]$ approv$ treatm5t options1 z c]tifi$ by a physician1 :o-- 7,i7 is 9 good /&+ ) ! physician's lic5s+ organization or bo>d2 7,,ii7 w n be comp5sat$ directly by ! manufactur] ( su* treatm5t = s c]tify+2 & 7,,iii7 atte/s to ! pati5t's life-?reat5+ disease or condition or sev]ely debilitat+ illness2 & 7iii7 provid$ to ! treat+ physician-- 7,i7 writt5 in=m$ cons5t reg>d+ ! eligible inve/igational drug or1 z applicable1 on ^: behalf a legally au?oriz$ repres5tative ( ! pati5t has provid$ su* cons5t2 or 7,,ii7 z applicable1 additional in=m$ cons5t1 reg>d+ ! inve/igational individualiz$ m$ical treatm5t1 or1 z applicable1 on ^: behalf a legally au?oriz$ repres5tative ( ! pati5t has provid$ su* cons5t2 2 7#b7 9 p>agraph 7#b77;,d71 by /rik+ & at ! end2 7#c7 9 p>agraph 7#c71 by /rik+ ! p]iod at ! end & ins]t+ a semicolon2 & 7#d7 by add+ at ! end ! foll[+3 7#d7 ! t]m eligible heal? c>e facility means a heal? c>e facility t is op]at+ "u ! ,f$]al assurance = protection ( human subjects pursuant to section #dia7;a7 ( ! ,public ,heal? ,s]vice ,act2 7#e7 ! t]m inve/igational individualiz$ m$ical treatm5t means a drug or biological product = ! pati5t bas$ on an analysis ( ! pati5t's unique g5omic pr(ile1 includ+ _! g5omic sequ5ce1 human *romosomes1 deoxyribonucleic acid1 g5es1 g5e products 7su* z enzymes & o!r types ( prote9s71 or metabolites2 & 7#f7 ! t]m additional in=m$ cons5t means cons5t atte/$ to 9 writ+ by ! pati5t's physician & a witness = an inve/igational individualiz$ m$ical treatm5t t includes-- 7,a7 an explanation ( ! curr5tly approv$ treatm5ts = ! pati5t's disease or condition2 7,b7 ! pati5t's atte/ation t ! pati5t concurs ) ! assessm5t ( _! physician t all curr5tly approv$ & conv5tionally recogniz$ treatm5ts are unlikely to prolong or improve _! life2 7,c7 cle> id5tification ( ! specific propos$ inve/igational individualiz$ m$ical treatm5t ! pati5t's physician recomm5ds2 & 7,d7 a description1 bas$ on ! physician's k ( ! propos$ treatm5t & ! pati5t's disease1 ( ! pot5tial outcomes ( ! treatm5t4 4 7b7 ,eligibility = inve/igational individualiz$ m$ical treatm5t ,section #efa;,b ( su* ,act 7#ba ,u4,s4,c4 #cfj;bbb-#j;a7 is am5d$-- 7#a7 by r$esignat+ subsections 7b7 ?r\gh 7d7 z subsections 7c7 ?r\gh 7e71 respectively2 & 7#b7 by ins]t+ aft] subsection 7a7 ! foll[+3 7b7 ,eligibility = inve/igational individualiz$ m$ical treatm5t ,a manufactur] ( an inve/igational individualiz$ m$ical treatm5t t is 9 compliance ) all applicable ,f$]al assurance laws & regulations & is op]at+ )9 an eligible heal? c>e facility may make available su* inve/igational individualiz$ m$ical treatm5t1 & an eligible pati5t may reque/ access to su* treatm5t f ! eligible heal? c>e facility or manufactur] ( su* treatm5t1 consi/5t ) ! requirem5ts ( ?is section4 ,a manufactur] ( an inve/igational individualiz$ m$ical treatm5t is n requir$ to make available su* treatm5t to any pati5t4 4 7c7 ,exemptions ,section #efa;,b7c7 ( su* ,act 7#ba ,u4,s4,c4 #cfj;bbb-#j;a7c771 z r$esignat$ by subsection 7b77#a7 ( ?is section1 is am5d$-- 7#a7 by ins]t+ & inve/igational individualiz$ m$ical treatm5ts aft] ,eligible inve/igational drugs2 7#b7 by ins]t+ or inve/igational individualiz$ m$ical treatm5t aft] su* eligible inve/igational drug2 7#c7 by ins]t+ or inve/igational individualiz$ m$ical treatm5t aft] an eligible inve/igational drug2 & 7#d7 by ins]t+ or inve/igational individualiz$ m$ical treatm5ts aft] inve/igational drugs4 7d7 ,con=m+ am5dm5ts ,section #efa;,b ( su* ,act 7#ba ,u4,s4,c4 #cfj;bbb-#j;a7 is am5d$-- 7#a7 9 ! section head+1 by ins]t+ & inve/igational individualiz$ m$ical treatm5ts aft] drugs2 & 7#b7 9 subsection 7e77#b71 z r$esignat$ by subsection 7b77#a7 ( ?is section-- 7,a7 9 subp>agraph 7,a71 by /rik+ subsection 7c77#a77;,a7 & ins]t+ subsection 7d77#a77;,a72 & 7,b7 9 subp>agraph 7,b71 by /rik+ subsection 7c77#a77;,b7 & ins]t+ subsection 7d77#a77;,b74