,i #aae? ,,congress #a/ ,session ,h4 ,r4 #bcfh ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,may #d1 #bjag,mr4 ,fitzpatrick 7= himself1 ,ms4 ,s9ema1 & ,mr4 ,biggs7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committee on ! ,judici>y1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to au?orize ! use ( exp]im5tal drugs1 biological products1 & devices by pati5ts diagnos$ ) a t]m9al illness 9 accordance ) ,/ate law1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,"r to ,try ,act4 #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 ! pati5t's treat+ physician 9 accordance ) subsection 7b74 7b7 ,physician c]tification ,a c]tification by ! pati5t's treat+ physician ref]r$ to 9 subsection 7a77#b77;,b7 mu/ include ea* ( ! foll[+3 7#a7 ,a c]tification t ! physician-- 7,a7 is 9 good /&+ ) ! physician's c]tify+ organization or bo>d2 & 7,b7 has p]sonally exam9$ ! pati5t4 7#b7 ,a c]tification t !re is no reason to conclude ! exp]im5tal drug1 biological product1 or device poses an unreasonable & significant risk ( dang] to ! pati5t4 7#c7 ,a c]tification t ! pati5t has be5 diagnos$ ) a t]m9al disease or condition & does n h any treatm5t options t-- 7,a7 are comp>able to treatm5t us+ ! exp]im5tal drug1 biological product1 or device or o!rwise satisfactory2 & 7,b7 are approv$1 lic5s$1 or cle>$ = comm]cial di/ribution "u section #eje1 #eaj7k71 or #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee1 #cfj7k71 #cfj7;e77 or section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 & are available to diagnose1 monitor1 or treat ! pati5t's disease or condition4 7#d7 ,a c]tification t ! probable risk to ! pati5t f ! exp]im5tal drug1 biological product1 or device is n great] ?an ! probable risk f ! pati5t's disease or condition4 7#e7 ,a c]tification t ! physician has provid$ ! pati5t ) a writt5 /atem5t & oral explanation ( ! m$ical treatm5t to be provid$ us+ ! exp]im5tal drug1 biological product1 or device4 7#f7 ,an ackn[l$gem5t sign$ by ! pati5t 7or ! pati5t's legal repres5tative7 t ! physician has provid$ ! writt5 /atem5t & oral explanation requir$ by p>agraph 7#e71 & has disclos$ ! foll[+3 7,a7 ,t ! m$ical treatm5t us+ ! exp]im5tal drug1 biological product1 or device is exp]im5tal or nonconv5tional4 7,b7 ,t ! exp]im5tal drug1 biological product1 or device has n be5 approv$1 lic5s$1 or cle>$ = comm]cial di/ribution "u section #eje1 #eaj7k71 or #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee1 #cfj7k71 #cfj7;e77 or section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 = any indication4 7,c7 ,! mat]ial risks g5]ally recogniz$ by a reasonably prud5t physician ( ! m$ical treatm5t's side effects4 7,d7 ,an explanation ( ! m$ical treatm5t1 includ+ ! expect$ frequ5cy & duration ( ! treatm5t4 7c7 ,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 compliance1 ) 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$]al ag5cy review+ ! exp]im5tal drug1 biological product1 or device to delay or o!rwise adv]sely impact review or approval ( su* exp]im5tal drug1 biological product1 or device4 7d7 ,rules ( con/ruction ,no?+ 9 ?is ,act %all be con/ru$ to-- 7#a7 require a manufactur] or o!r p]son to make available any exp]im5tal drug1 biological product1 or device2 or 7#b7 prohibit a manufactur] or o!r p]son f receiv+ comp5sation or recov]+ co/s = ! production1 manufacture1 di/ribution1 or sale ( an exp]im5t drug1 biological product1 or device4 7e7 ,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$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee1 #cfj7k71 #cfj7;e77 or section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 7#d7 ,phase #a cl9ical inve/igation ,! t]m phase #a cl9ical inve/igation means a phase #a cl9ical inve/igation1 z describ$ 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