,,ii #aad? ,,congress #b;d ,session ,s4 #biab ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,may #aj1 #bjaf,mr4 ,johnson introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to au?orize ! use ( unapprov$ m$ical products by pati5ts diagnos$ ) a t]m9al illness 9 accordance ) ,/ate law1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,trickett ,w5dl] ,"r to ,try ,act ( #bjaf4 #b4 ,use ( unapprov$ m$ical products by pati5ts diagnos$ ) a t]m9al illness 7a7 ,9 g5]al ,not)/&+ ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq471 ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hja et seq471 & any o!r provision ( ,f$]al law1 ! ,f$]al ,gov]nm5t %all n take any action to prohibit or re/rict-- 7#a7 ! production1 manufacture1 di/ribution1 prescrib+1 or disp5s+ ( an exp]im5tal drug1 biological product1 or device t-- 7,a7 is int5d$ to treat a pati5t :o has be5 diagnos$ ) a t]m9al illness2 & 7,b7 is au?oriz$ by1 & 9 accordance )1 ,/ate law2 & 7#b7 ! possession or use ( an exp]im5tal drug1 biological product1 or device-- 7,a7 t is describ$ 9 subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#a72 & 7,b7 = :i* ! pati5t has receiv$ a c]tification f a physician1 :o is 9 good /&+ ) ! physician's c]tify+ organization or bo>d1 t ! pati5t has exhau/$1 or o!rwise does n meet qualify+ crit]ia to receive1 any o!r available treatm5t options4 7b7 ,no liability or use ( outcomes 7#a7 ,no liability ,not)/&+ any o!r provision ( law1 no liability %all lie aga9/ a produc]1 manufactur]1 di/ributor1 prescrib]1 disp5s]1 possessor1 or us] ( an exp]im5tal drug1 biological product1 or device = ! production1 manufacture1 di/ribution1 prescrib+1 disp5s+1 possession1 or use ( an exp]im5tal drug1 biological product1 or device t is 9 compliance ) subsection 7a74 7#b7 ,no use ( outcomes ,not)/&+ any o!r provision ( law1 ! outcome ( any production1 manufacture1 di/ribution1 prescrib+1 disp5s+1 possession1 or use ( an exp]im5tal drug1 biological product1 or device t 0 done 9 compliance ) subsection 7a7 %all n be us$ by a ,f$]al ag5cy review+ ! exp]im5tal drug1 biological product1 or device to delay or o!rwise adv]sely impact review or approval ( su* exp]im5tal drug1 biological product1 or device4 7c7 ,def9itions ,9 ?is section3 7#a7 ,biological product ,! t]m biological product has ! mean+ giv5 to su* t]m 9 section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 7#b7 ,device2 drug ,! t]ms device & drug h ! mean+s giv5 to su* t]ms 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba74 7#c7 ,exp]im5tal drug1 biological product1 or device ,! t]m exp]im5tal drug1 biological product1 or device means a drug1 biological product1 or device t-- 7,a7 has successfully complet$ a phase #a cl9ical inve/igation2 7,b7 rema9s "u inve/igation 9 a cl9ical trial approv$ by ! ,food & ,drug ,adm9i/ration2 & 7,c7 is n approv$1 lic5s$1 or cle>$ = comm]cial di/ribution "u section #eje1 #eaj7k71 or #eae ( ! ,f$]al ,food1 ,drug1 or ,cosmetic ,act 7#ba ,u4,s4,c4 #cee1 #cfj7k71 #cfj7;e77 or section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 7#d7 ,phase #a cl9ical inve/igation ,! t]m phase #a cl9ical inve/igation means a phase #a cl9ical inve/igation1 z describ$ 9 section #cab4ba ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7#e7 ,t]m9al illness ,! t]m t]m9al illness has ! mean+ giv5 to su* t]m 9 ! ,/ate law specifi$ 9 subsection 7a77#a77;,b74 #c4 ,,fda report to ,congress ,n lat] ?an #cj days aft] ! date ( enactm5t ( ?is ,act1 & e #cj days !reaft] until implem5tation is complete1 ! ,commission] ( ,food & ,drugs %all report to ,congress on progress 9 implem5t+ ! propos$ /reaml9$ exp&$ access application process = exp]im5tal drugs t are int5d$ to treat a pati5t :o has be5 diagnos$ ) a t]m9al illness4