,,ii #aaf? ,,congress #a/ ,session ,s4 #cacc ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,decemb] #ai1 #bjai,mr4 ,braun introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to e/abli% a "t-limit$ conditional approval pa?way1 subject to specific obligations1 = c]ta9 drugs1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,conditional ,approval ,act4 #b4 ,conditional approval ( new human drugs 7a7 ,9 g5]al ,sub*apt] ,a ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by add+ at ! end ( ! foll[+3 #ebd;,b4 ,conditional & "t limit$ approval pa?way = new drugs 7a7 ,pa?way requirem5ts ,! ,secret>y %all1 at ! reque/ ( ! sponsor ( a new drug1 grant provisional & "t-limit$ approval ( su* drug "u ?is section1 if ! ,secret>y det]m9es t-- 7#a7 x is likely t ! sponsor w be able to provide compreh5sive cl9ical data aft] su* drug is conditionally approv$2 7#b7 su* drug is int5d$ = ! treatm5t1 prev5tion1 or m$ical diagnosis ( a s]i\sly debilitat+ disease1 a life-?reat5+ disease1 or a *ronic condition2 7#c7 ! expect$ b5efits ( ! drug outweigh ! pot5tial risks to pati5ts1 tak+ into acc\nt ! fact t additional data are /ill requir$ to assess ! drug & ! sev]ity ( ! und]ly+ disease or condition ! drug is int5d$ to treat2 7#d7 !re are no exi/+ mean+ful treatm5ts = ! disease or condition t ! drug is int5d$ to treat2 7#e7 confirmatory cl9ical trials are difficult or co/ly to conduct2 & 7#f7 su* drug is int5d$ to treat a disease or condition = :i* no m ?an #b mean+ful treatm5ts curr5tly exi/4 7b7 ,approval requirem5ts 7#a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date on :i* ! ,secret>y receives a reque/ = conditional approval "u subsection 7a7 ) respect to a new drug1 ! ,secret>y %all require ! sponsor ( su* drug to-- 7,a7 complete 9 a timely mann] cl9ical inve/igations to provide full demon/ration ( safety & effectiv5ess z describ$ 9 section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 z applicable2 7,b7 conduct cl9ical trials o!r ?an confirmatory trials1 to demon/rate a c]ta9 degree ( safety & efficacy ( ! drug2 & 7,c7 demon/rate t necess>y po/-m>ket surveillance & risk-managem5t tools are 9 place ) respect to ! drug4 7#b7 ,p]iod ( conditional approval ,! p]iod ( conditional approval = a drug "u ?is subsection is effective = #a ye>1 & is r5ewable by ! ,secret>y = up to #d additional #a-ye> t]ms4 ,a conditional approval %all be 9 effect = n m ?an #e ye>s f ! date on :i* conditional approval is fir/ grant$4 7#c7 ,"t limitation ,if any conditionally drug approv$ "u ?is section is n br\ght to m>ket )9 #c ye>s ( ! conditional approval1 any conditional approval grant$ "u ?is section ) respect to su* drug %all be deem$ invalid4 7#d7 ,requirem5ts ,z a condition on receipt ( conditional approval "u ?is section1 ! ,secret>y %all require ! sponsor ( ! drug to agree to ! foll[+3 7,a7 ,complete 9 a timely mann] su* cl9ical inve/igations to provide a full demon/ration ( effectiv5ess z ! ,secret>y det]m9es to be necess>y = approval ( ! drug "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 z applicable4 7,b7 ,submit to ! ,secret>y an annual report on ! progress ( ! sponsor 9 conduct+ ! cl9ical inve/igations requir$ "u ?is section4 7,c7 ,ensure t all label+ & promotional mat]ials = ! drug be> ! /atem5t conditionally approv$ by ! ,,fda p5d+ a full demon/ration ( effectiv5ess "u applicable 7specify+ ! application numb] assign$ by ! ,secret>y 9 place ( ! blank74 7#e7 ,apply+ = full approval ,! sponsor ( a drug grant$ conditional approval pursuant to ?is subsection may1 at any po9t1 submit an application = full approval z describ$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 z applicable4 7#f7 ,utilization ( real _w evid5ce to support full approval ,! ,secret>y %all all[ ! use ( real _w evid5ce1 z def9$ 9 section #eje;,f7b71 & collect$ by ! sponsor ( a drug dur+ ! duration ( conditional approval grant$ approval to ?is subsection1 to supplem5t an application = full approval1 9 addition to o!r po/-approval /udies4 7c7 ,limitation on liability 7#a7 ,9 g5]al ,) respect to any claim "u ,/ate law alleg+ t a drug sold or o!rwise made available pursuant to a grant ( conditional approval "u ?is subsection is unsafe or ineffective1 no liability 9 a cause ( action %all lie aga9/ a sponsor or manufactur]1 unless ! relevant conduct con/itutes reckless or willful misconduct1 gross neglig5ce1 or an int5tion tort "u any applicable ,/ate law4 7#b7 ,rule ( con/ruction ,except z set =? 9 subp>agraph 7,a71 no?+ 9 ?is subsection %all be con/ru$ to modify or o!rwise affect ! "r ( any p]son to br+ private action "u any ,f$]al or ,/ate product liability1 tort1 consum] protection1 or w>ranty law4 7d7 ,def9itions ,9 ?is section3 7#a7 ,s]i\sly debilitat+ disease ,! t]m sev]ely debilitat+ disease means a disease or condition t causes major irrev]sible morbidity4 7#b7 ,life-?reat5+ disease ,! t]m life-?reat5+ disease means-- 7,a7 a disease or condition :]e ! likelihood ( dea? is high unless ! c\rse ( ! disease is int]rupt$2 or 7,b7 a disease or condition ) pot5tially fatal outcomes1 :]e ! end po9t ( cl9ical trial analysis is survival4 7#c7 ,*ronic condition ,! t]m *ronic condition means a disease or condition t-- 7,a7 usually la/s = #c mon?s or long]2 & 7,b7 7i7 requires ongo+ m$ical att5tion2 or 7ii7 limits activities ( daily liv+4 4 7b7 ,regulations & guidance ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue f9al regulations & guidance = c>ry+ out section #ebd;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a74 7c7 ,con=m+ am5dm5t ,section #eje7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;a77 is am5d$ by ins]t+ 1 or !re is 9 effect a conditional approval "u section #ebd;,b ) respect to su* drug be=e ! p]iod4