,i #aae? ,,congress #a/ ,session ,h4 ,r4 #gdi ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,janu>y #cj1 #bjag,mr4 ,s*rad] 7= himself1 ,mr4 ,bilirakis1 ,mr4 ,lip9ski1 ,mr4 ,m\lton1 ,mr4 ,b]a1 ,ms4 ,s9ema1 ,mr4 ,coop]1 ,mr4 ,posey1 ,mr4 ,co/a1 & ,mr4 ,pet]s7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to increase competition 9 ! ph>maceutical indu/ry4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,l[] ,drug ,co/s ?r\gh ,competition ,act4 #b4 ,f9d+s ,congress f9ds ! foll[+3 7#a7 ,z "p ( ! ,food & ,drug ,adm9i/ration's mission to protect ! public heal?1 ! ,food & ,drug ,adm9i/ration approves g5]ic drugs t help e/abli% competitive m>kets = treatm5ts t improve ! lives ( millions ( pati5ts 9 ! ,unit$ ,/ates4 7#b7 ,ris+ heal? c>e co/s1 includ+ prescription drug co/s1 cont9ue to be a major conc]n = pati5ts 9 ! ,unit$ ,/ates4 7#c7 ,eighty-eight p]c5t ( prescription drugs disp5s$ 9 ! ,unit$ ,/ates1 or ne>ly #i out ( e #aj prescriptions disp5s$1 are g5]ic drugs4 7#d7 ,/udies sugge/ t g5]ic drugs acc\nt = only #bh p]c5t ( total prescription drug sp5d+ & 7 responsible = #a1fhj1jjj1jjj1jjj 9 e/imat$ sav+s ov] ! p]iod ( #bjje to #bjad4 7#e7 ,increas+ g5]ic competition c be an effective way to help keep prescription drug co/s l[ = pati5ts1 ! heal? c>e sy/em1 & ,f$]al & ,/ate gov]nm5t4 7#f7 ,:ile ! ,food & ,drug ,adm9i/ration has made progress t[>d a m consi/5t timel9e = g5]ic drug approvals s9ce ! enactm5t ( ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjab 7#ba ,u4,s4,c4 #cgi;j-#da et seq471 a significant backlog ( abbreviat$ new drug applications = g5]ic drugs rema9s4 7#g7 ,! sudd51 aggressive price hikes = a v>iety ( rec5tly acquir$ (f-pat5t drugs t h be5 us$ widely = decades1 = :i* !re is no g5]ic drug competitor1 also affects access to af=dable prescriptions = pati5ts & ! ov]all co/ ( heal? c>e 9 ! ,unit$ ,/ates4 7#h7 ,improv+ ! review ( abbreviat$ new drug applications & ! approval ( g5]ic drugs w\ld help to improve competition & l[] prices = pati5ts4 7#i7 ,e/abli%+ a cle> timeframe = ! ,food & ,drug ,adm9i/ration to exp$ite ! review ( c]ta9 applications = g5]ic drugs w\ld also help keep drug prices d[n & improve timely access = pati5ts4 ,i ,remov+ regulatory b>ri]s to competition #aja4 ,improv+ g5]ic access ,section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 is am5d$ by add+ at ! end ! foll[+3 7#aa7 7,a7 ,! ,secret>y %all prioritize ! review1 & act n lat] ?an #ahj cal5d> days aft] ! date ( ! submission ( an application1 on an application t has be5 submitt$ & accept$ = review "u ?is subsection1 or on a supplem5t to su* an application1 t is = a drug t-- 7i7 has be5 introduc$ into int]/ate comm]ce by n m ?an "o manufactur] or sponsor1 z applicable1 9 ! la/ #c mon?s & ) respect to :i* t5tative approval "u p>agraph 7#e7 has be5 grant$ = n m ?an #b applications2 or 7ii7 has be5 includ$ on ! li/ "u section #ejf;,e4 7,b7 ,! ,secret>y may exp$ite an inspection or re9spection "u section #gjd ( an e/abli%m5t t proposes to manufacture a drug describ$ 9 subp>agraph 7,a74 4 #ajb4 ,report+ on p5d+ g5]ic drug applications ,n lat] ?an #ahj cal5d> days aft] ! date ( enactm5t ( ?is ,act1 & e #ahj cal5d> days !reaft] until ,octob] #a1 #bjbc1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate1 ! ,special ,committee on ,ag+ ( ! ,s5ate1 & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report t provides-- 7#a7 ! numb] ( applications t 7 fil$ "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 prior to ,octob] #a1 #bjag1 t are p5d+ at ! "t ! report is submitt$2 7#b7 ! av]age & m$ian total "t su* applications h be5 p5d+2 7#c7 ! numb] ( su* applications t conta9 c]tifications "u section #eje7;j77#b77;,a77vii77,,iv7 ( su* ,act2 & 7#d7 ! numb] ( su* applications t are subject to priority review4 ,,ii ,inc5tiviz+ competition #bja4 ,g5]ic priority review v\*] ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by ins]t+ aft] section #ejf;,f ! foll[+3 #ejf;,g4 ,g5]ic priority review v\*] 7a7 ,def9itions ,9 ?is section3 7#a7 ,! t]m priority review ) respect to an application "u section #eje7;j7 means review & action by ! ,secret>y on su* application by ! ,secret>y n lat] ?an #ahj cal5d> days aft] su* application has be5 submitt$ & accept$ = review4 7#b7 ,! t]m priority review v\*] means a v\*] = priority review = an application "u section #eje7;j74 ,su* v\*] %all be aw>d$ ^u ! approval ( ! application describ$ 9 #eje7;j77#aa77;,a71 unless su* application conta9s a c]tification "u section #eje7;j77#b77;,a77vii77,,iv74 7b7 ,g5]ic ,priority ,review ,v\*]s1 9 g5]al ,beg9n+ on ,octob] #a1 #bjah1 ! ,secret>y %all aw>d a priority review v\*] to ! sponsor ( an application describ$ 9 section #eje7;j77#aa77;,a7 ^u-- 7#a7 approval by ! ,secret>y ( su* application2 7#b7 m>ket+ ( ! drug subject to su* application2 & 7#c7 det]m9ation by ! ,secret>y t ! drug has a su/a9$ m>ket pres5ce4 7c7 ,transf]ability 7#a7 ,9 g5]al ,! recipi5t ( a priority review v\*] "u subsection 7a7 may transf] 7includ+ by sale7 ! entitlem5t to su* v\*]4 ,!re is no limit on ! numb] ( times a priority review v\*] may be transf]r$ be=e su* v\*] is us$4 7#b7 ,notification to ! ,secret>y ,ea* p]son to :om a v\*] is transf]r$ %all notify ! ,secret>y ( su* *ange 9 own]%ip ( su* v\*] n lat] ?an #cj cal5d> days aft] su* transf]4 7d7 ,notification ,! sponsor %all notify ! ,secret>y n lat] ?an #cj cal5d> days prior to ! submission ( a human drug application t is int5d$ to be ! subject ( a priority review v\*]1 except 9 ! case ( su* an application t 0 p5d+ z ( ,octob] #a1 #bjah1 9 :i* case ! sponsor ( su* p5d+ application %all notify ! ,secret>y n lat] ?an #cj days aft] ! date on :i* su* v\*] is aw>d$4 7e7 ,fees 7#a7 ,9 g5]al ,! sponsor ( an application t is ! subject ( a priority review v\*] %all be subject to ! fees requir$ "u sub*apt] ,c ( *apt] ,,vii4 7#b7 ,priority review us] fee 7,a7 ,9 g5]al ,! ,secret>y %all e/abli% a us] fee program "u :i* a sponsor ( a human drug application t is ! subject ( a priority review v\*] %all pay to ! ,secret>y a fee det]m9$ "u subp>agraph 7,b74 ,su* fee %all be 9 addition to any fee requir$ to be submitt$ by ! sponsor "u sub*apt] ,c ( *apt] ,,vii4 7,b7 ,fee am\nt ,! am\nt ( ! priority review us] fee %all be det]m9$ ea* fiscal ye> by ! ,secret>y1 bas$ on twice ! diff]5ce betwe5-- 7i7 ! av]age co/ incurr$ by ! ,food & ,drug ,adm9i/ration 9 ! review ( a human drug application subject to priority review "u ?is section 9 ! previ\s fiscal ye>2 & 7ii7 ! av]age co/ incurr$ by ! ,food & ,drug ,adm9i/ration 9 ! review ( a human drug application "u section #eje7;j7 t is n subject to priority review "u ?is section 9 ! previ\s fiscal ye>4 7,c7 ,annual fee sett+ ,! ,secret>y %all e/abli%1 be=e ! beg9n+ ( ea* fiscal ye> beg9n+ aft] ,septemb] #cj1 #bjah1 & 9 accordance ) subp>agraph 7,b71 ! am\nt ( ! priority review us] fee = t fiscal ye>4 7,d7 ,paym5t 7i7 ,9 g5]al ,! priority review us] fee requir$ by ?is p>agraph %all be due ^u ! notification by a sponsor ( ! int5t ( su* sponsor to use ! v\*]1 z specifi$ 9 subsection 7d74 ,all o!r us] fees associat$ ) ! human drug application %all be due z requir$ by ! ,secret>y or "u applicable law4 7ii7 ,complete application ,an application describ$ 9 clause 7i7 = :i* ! sponsor reque/s ! use ( a priority review v\*] %all be consid]$ incomplete if ! fee requir$ by ?is p>agraph & all o!r applicable us] fees are n paid 9 accordance ) ! ,secret>y's proc$ures = pay+ su* fees4 7iii7 ,no waiv]s1 exemptions1 r$uctions1 or refunds ,! ,secret>y may n grant a waiv]1 exemption1 r$uction1 or refund ( any fees due & payable "u ?is p>agraph4 7,e7 ,(fsett+ collections ,fees collect$ pursuant to ?is p>agraph = any fiscal ye>-- 7i7 %all be deposit$ & cr$it$ z (fsett+ collections to ! acc\nt provid+ appropriations to ! ,food & ,drug ,adm9i/ration2 & 7ii7 %all n be collect$ = any fiscal ye> except to ! ext5t provid$ 9 advance 9 appropriations ,acts4 7f7 ,cl>ification ,no?+ 9 ?is section affects any p]iod ( exclusivity "u ?is ,act or ! protection ( any pat5t4 7g7 ,sunset ,! au?ority ( ! ,secret>y to c>ry out ! g5]ic priority review v\*] program "u ?is section %all t]m9ate on ,octob] #a1 #bjbc4 4 #bjb4 ,tropical disease product application ,section #ebd7;a77#d77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjn7a77#d77;,a77 is am5d$-- 7#a7 9 clause 7i71 by /rik+ &2 7#b7 9 clause 7ii71 by add+ & aft] ! semicolon2 & 7#c7 by add+ at ! end ! foll[+3 7iii7 t conta9s reports ( new cl9ical inve/igations 7o!r ?an bioavailability /udies7 ess5tial to ! approval ( ! application & conduct$ or sponsor$ by ! applicant2 4 ,,iii ,/udy on ,,rems #cja4 ,/udy on ,,rems 7a7 ,9 g5]al ,! ,comptroll] ,g5]al %all conduct a review ( ! implem5tation & effectiv5ess ( section #eje-a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7 7ref]r$ to 9 ?is section z ! ,,rems program71 :i* section-- 7#a7 au?orizes ! ,secret>y ( ,heal? & ,human ,s]vices to require a risk evaluation & mitigation /rategy 7ref]r$ to 9 ?is section z ,,rems72 & 7#b7 codifies & exp&s regulations issu$ by ! ,food & ,drug ,adm9i/ration "u :i* ! ,food & ,drug ,adm9i/ration may impose re/rictions on di/ribution necess>y to ensure a drug is safely us$4 7b7 ,cont5ts ( /udy ,9 conduct+ ! review "u subsection 7a71 ! ,comptroll] ,g5]al %all exam9e ea* relevant elem5t describ$ 9 subsection 7c7 ) respect to ea* ( ! foll[+ categories3 7#a7 ,new drug applications "u subsection 7b7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b774 7#b7 ,abbreviat$ new drug applications "u subsection 7j7 ( su* section4 7#c7 ,applications = ! lic5se ( a biological product "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 7#d7 ,s+le1 %>$ sy/em ,,rems1 z describ$ 9 section #eje-a7;i7 ( ! ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;i774 7#e7 ,controll$ sub/ances z def9$ 9 section #ajb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hjb74 7#f7 ,r,i,s,k,m,a,ps or o!r risk managem5t processes employ$ by ! ,food & ,drug ,adm9i/ration4 7c7 ,elem5ts "u review ,9 conduct+ ! review "u subsection 7a71 ! ,comptroll] ,g5]al %all exam9e ea* ( ! foll[+ elem5ts ) respect to ea* relevant category describ$ 9 subsection 7b74 7#a7 ,= ea* type ( application1 & by ye>1 ! numb] ( ,,rems requir$1 submitt$1 volunt>ily submitt$1 modifi$1 add$1 approv$1 or remov$1 & :e!r ^? ,,rems includ$ elem5ts to assure safe use1 su* z re/rict$ di/ribution4 7#b7 ,= ea* type ( application1 ! numb] ( ,,rems 9 effect at ! "t ( ! review & ! numb] ( ye>s t ea* su* ,,rems has be5 9 effect at su* "t4 7#c7 ,if & h[ ! ,,rems program has improv$ drug safety1 z comp>$ to ! "t be=e ! ,,rems program became effective1 & h[ ! ,food & ,drug ,adm9i/ration tracks su* improvem5ts4 7#d7 ,! burd5s associat$ ) ,,rems1 includ+ burd5s on pati5ts1 heal? c>e provid]s1 g5]ic drug manufactur]s1 br& drug manufactur]s1 ph>macies1 & :olesale di/ributors4 7#e7 ,9 ! case ( a ,,rems program = a drug conta9+ a controll$ sub/ance1 ! coord9ation betwe5 ! ,food & ,drug ,adm9i/ration & ! ,drug ,en=cem5t ,adm9i/ration4 7#f7 ,! effect ( additional risk mitigation /rategies1 includ+ non-,,rems re/rict$ di/ribution sy/ems1 impos$ by companies outside ( :at is requir$ "u ! ,,rems program4 7#g7 ,! /&>ds & policies appli$ by ! ,food & ,drug ,adm9i/ration to require1 modify1 add1 or remove a ,,rems1 & h[ ^? /&>ds & policies h *ang$ s9ce ! ,,rems program became effective4 7#h7 ,! effect ( ,,rems programs & additional risk mitigation /rategies1 includ+ non-,,rems re/rict$ di/ribution sy/ems1 on g5]ic entry into ! m>ketplace4 7#i7 ,! effect ( ,,rems programs & additional risk mitigation /rategies1 includ+ non-,,rems re/rict$ di/ribution sy/ems1 on ph>maceutical prices4 7d7 ,report ,n lat] ?an ,may #a1 #bjah1 ! ,comptroll] ,g5]al %all submit a report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate1 ! ,special ,committee on ,ag+ ( ! ,s5ate1 & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 conta9+ ! results ( ! review describ$ 9 ?is section4