,,ii #aae? ,,congress #a/ ,session ,s4 #aaae ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,may #aa1 #bjag,ms4 ,coll9s 7= h]self1 ,mrs4 ,mc,caskill1 ,mr4 ,cotton1 & ,mr4 ,frank57 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to improve access to prescription drugs4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,mak+ ,ph>maceutical ,m>kets ,m ,competitive ,act4 ,i ,remov+ regulatory b>ri]s to competition #aja4 ,improv+ access to g5]ic drugs ,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 ! review (1 & act )9 #bdj cal5d> days ( ! date ( ! submission (1 an orig9al abbreviat$ new drug application submitt$ = review "u ?is subsection1 or on a supplem5t to su* an application1 t is = a drug-- 7i7 = :i* !re are n m ?an #c approv$ drugs li/$ "u p>agraph 7#g71 except t ! review ( an application submitt$ m ?an #cj mon?s 9 advance ( ! la/ applicable expiration date = a pat5t = :i* a c]tification "u p>agraph 7#b77;,a77vii77,,iii7 has be5 submitt$1 or ( ! expiration date = an applicable p]iod ( exclusivity "u ?is ,act1 w n be exp$it$2 or 7ii7 t has be5 includ$ on ! li/ "u section #ejf;,e4 7,b7 ,! ,secret>y %all require ! applicant1 n lat] ?an #fj days prior to ! submission ( an application describ$ 9 subp>agraph 7,a71 to provide complete1 accurate in=mation reg>d+ facilities involv$ 9 manufactur+ processes & te/+1 includ+ facilities 9 correspond+ ,type ,,ii active ph>maceutical +r$i5ts drug ma/] files submitt$ ) an application & sites or organizations involv$ 9 bioequival5ce & cl9ical /udies us$ to support ! application1 9 ord] to make a det]m9ation reg>d+ :e!r an inspection ( an e/abli%m5t is necess>y4 7,c7 ,! ,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 7,d7 ,no?+ 9 ?is p>agraph %all prev5t ! ,secret>y f prioritiz+ ! review ( o!r applications z ! ,secret>y det]m9es appropriate4 7#ab7 ,! ,secret>y %all provide review /atus updates to applicants reg>d+ applications "u ?is subsection1 z appropriate1 includ+ :5 ! application is await+ f9al regulatory action by ! (fice *>g$ ) review4 7#ac7 ,! ,secret>y %all publi% on ! ,int]net website ( ! ,food & ,drug ,adm9i/ration a li/ ( all drugs approv$ "u subsection 7b7 = :i* all pat5ts & p]iods ( exclusivity "u ?is ,act h expir$4 ,su* li/ %all be updat$ at lea/ once e #ahj days4 4 #ajb4 ,report+ on p5d+ g5]ic drug applications1 priority review applications1 & inspections 7a7 ,9 g5]al ,n lat] ?an #ahj cal5d> days aft] ! date ( enactm5t ( ?is ,act1 & qu>t]ly !reaft] until ,octob] #a1 #bjbb1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all po/ on ! ,int]net website ( ! ,food & ,drug ,adm9i/ration a report t provides-- 7#a7 ! numb] ( applications fil$ "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 await+ action by ! applicant1 includ+ su* applications t 7 fil$ prior to ,octob] #a1 #bjad2 7#b7 ! numb] ( applications fil$ "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 await+ action by ! ,secret>y1 includ+ su* applications t 7 fil$ prior to ,octob] #a1 #bjad2 7#c7 ! numb] ( applications fil$ "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 & prior approval supplem5ts )drawn 9 ea* mon? cov]$ by ! report2 7#d7 ! mean & m$ian approval & t5tative approval times = applications cov]$ by ! report2 7#e7 ! numb] ( applications describ$ 9 p>agraphs 7#a71 7#b71 & 7#c7 t are subject to priority review2 & 7#f7 ! numb] ( su* applications on :i* ! ,secret>y has tak5 action pursuant to section #ejf;,h7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #aja4 7b7 ,annual report on priority review applications 7#a7 ,9 g5]al ,! ,secret>y %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,special ,committee on ,ag+ ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives an annual report1 n lat] ?an ,m>* #ca ( ea* ye>1 on ! foll[+3 7,a7 ,! numb] ( applications fil$ "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 t are subject to priority review dur+ ! mo/ rec5t cal5d> ye> & are await+ action by ! applicant4 7,b7 ,! numb] ( applications fil$ "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 t are subject to priority review dur+ ! mo/ rec5t cal5d> ye> & are await+ action by ! ,secret>y4 7,c7 ,! numb] ( applications fil$ "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 t are subject to priority review dur+ ! mo/ rec5t cal5d> ye> & h be5 approv$ by ! ,secret>y4 7,d7 ,= ea* ( subp>agraphs 7,a7 ?r\gh 7,c71 ! numb] ( su* applications-- 7i7 = :i* !re are n m ?an #c approv$ drugs li/$ "u section #eje7;j77#g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g772 & 7ii7 ! numb] ( su* applications t are = a drug on ! drug %ortage li/ "u section #ejf;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e74 7c7 ,annual report on inspections ,n lat] ?an ,m>* #a ( ea* ye>1 ! ,secret>y %all po/ on ! ,int]net website ( ! ,food & ,drug ,adm9i/ration-- 7#a7 ! av]age & m$ian am\nt ( "t1 foll[+ a reque/ by /aff ( ! ,food & ,drug ,adm9i/ration review+ an application or report submitt$ "u an applicable section describ$ 9 subp>agraph 7,a71 7,b71 or 7,c71 to s*$ule & complete inspections ( facilities necess>y =-- 7,a7 approval ( a drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee72 7,b7 approval ( a device "u section #eae ( su* ,act 7#ba ,u4,s4,c4 #cfj;e72 & 7,c7 cle>ance ( a device "u section #eaj7k7 ( su* ,act 7#ba ,u4,s4,c4 #cfj7k772 & 7#b7 ! av]age & m$ian am\nt ( "t to s*$ule & complete =-cause inspections ( facilities ( drugs & devices4 ,,ii ,inc5tiviz+ competition #bja4 ,exp$it+ g5]ic competition ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by ins]t+ aft] section #ejf;,g ! foll[+3 #ejf;,h4 ,exp$it+ g5]ic drug developm5t 7a7 ,9 g5]al ,! ,secret>y %all1 at ! reque/ ( an applicant1 exp$ite ! developm5t & review ( an application "u subsection 7j7 ( section #eje = a drug-- 7#a7 = :i* !re are n m ?an #c approv$ drug products li/$ "u section #eje7;j77#g72 or 7#b7 t is includ$ on ! li/ "u section #ejf;,e4 7b7 ,reque/ f sponsors ,a reque/ to exp$ite ! developm5t & review ( an application "u subsection 7a7 %all be submitt$ by ! applicant prior to ! submission ( su* application4 7c7 ,o!r applications ,no?+ 9 ?is section %all prev5t ! ,secret>y f exp$it+ ! developm5t & review ( o!r applications z ! ,secret>y det]m9es appropriate4 7d7 ,additional communication ,! ,secret>y %all take su* actions z are appropriate to exp$ite ! developm5t & review ( ! application = approval ( a drug describ$ 9 subsection 7a71 includ+1 z appropriate-- 7#a7 hold+ meet+s ) ! sponsor & ! review team ?r\gh\t ! developm5t ( ! drug prior to submission ( ! application2 7#b7 provid+ timely advice to1 & int]active communication )1 ! sponsor reg>d+ ! developm5t ( ! application to ensure t ! collection ( noncl9ical & cl9ical data necess>y = approval is z effici5t z practicable2 7#c7 9 ! case ( a complex product1 assign+ a cross-discipl9>y project lead = ! review team to facilitate an effici5t review ( ! developm5t program & application1 includ+ manufactur+ inspections2 & 7#d7 9 ! case ( a complex product1 includ+ drug-device comb9ations1 involv+ s5ior manag]s & exp]i5c$ review /aff1 z appropriate1 9 a collaborative1 cross-discipl9>y review4 7e7 ,report+ requirem5t ,a sponsor ( a drug exp$it$ "u ?is section %all report to ! ,secret>y1 "o ye> foll[+ approval ( an application "u section #eje7;j71 on :e!r ! approv$ drug has be5 m>ket$ 9 int]/ate comm]ce s9ce approval4 4 #bjb4 ,li/ ( g5]ic drugs ) limit$ competition ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by ins]t+ aft] section #ejf;,h1 z add$ by section #bja1 ! foll[+3 #ejf;,i4 ,drug li/+ 7a7 ,removal1 )drawal1 or transf] ,! hold] ( an application approv$ "u subsection 7b7 or 7j7 ( section #eje %all notify ! ,secret>y )9 #ahj days ( remov+ ! drug t is ! subject ( su* application f int]/ate comm]ce1 )draw+ su* approv$ application1 or transf]r+ su* approv$ application1 & a reason = su* removal1 )drawal1 or transf]4 ,if compliance ) ?is subsection )9 su* #ahj-;day p]iod is n practicable1 !n ! hold] %all comply z soon z practicable4 ,! ,secret>y %all cross-ref]5ce in=mation li/$ pursuant to section #ejf;,c :]e applicable to avoid duplicative report+4 ,notification to ! ,secret>y by a manufactur] 9 accordance ) section #ejf;,c7a7 %all be deem$ to be compliance ) ?is section4 7b7 ,drugs ) limit$ competition 7#a7 ,in=mation ,! ,secret>y %all-- 7,a7 ma9ta9 in=mation ) respect to applications approv$ "u section #eje7;j72 & 7,b7 publi% on ! ,int]net website ( ! ,food & ,drug ,adm9i/ration su* in=mation "u subp>agraph 7,a7 ) respect to drugs = :i* !re are ?ree or few] application hold]s2 & 7,c7 update ! in=mation publi%$ pursuant to subp>agraph 7,b7 e #ahj days4 7#b7 ,cont5ts ,! public in=mation ma9ta9$ & publi%$ "u p>agraph 7#a77;,b7 %all include-- 7,a7 ! "n ( ! drug1 "n ( ! hold] ( ! approv$ application1 & ! m>ket+ /atus = ea* drug2 & 7,b7 an indication ( :e!r ! ,secret>y consid]s ! drug to be = ! treatm5t or prev5tion ( a s]i\s disease or m$ical condition1 = :i* !re is no alt]native drug t is judg$ by m$ical pr(essionals to be an adequate sub/itute available 9 adequate supply4 7c7 ,public heal? exception ,! ,secret>y may *oose n to make in=mation collect$ "u ?is section publicly available if ! ,secret>y det]m9es t disclosure ( su* in=mation w\ld adv]sely affect ! public heal?4 7d7 ,notification ,:5 ! ,secret>y fir/ publi%es ! in=mation "u subsection 7b71 ! ,secret>y %all notify relevant ,f$]al ag5cies1 includ+ ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices & ! ,f$]al ,trade ,commission1 t ! in=mation has be5 publi%$ & w be updat$ regul>ly4 4 #bjc4 ,suitability petitions 7a7 ,9 g5]al ,x is ! s5se ( ! ,s5ate t ! ,food & ,drug ,adm9i/ration %all meet ! requirem5t "u section #eje7;j77#b77;,c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,c77 & section #cad4ic7;e7 ( title #ba1 ,code ( ,f$]al ,regulations1 ( respond+ to suitability petitions )9 #ij days ( submission4 7b7 ,report ,! ,secret>y ( ,heal? & ,human ,s]vices %all include 9 ! annual reports "u section #ajb7;b7-- 7#a7 ! numb] ( p5d+ petitions "u section #eje7;j77#b77;,c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,c772 & 7#b7 ! numb] ( su* petitions p5d+ a sub/antive response = m ?an #ahj days f ! date ( receipt4 #bjd4 ,inspections ,section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j771 z am5d$ by section #aja1 is fur!r am5d$ by add+ at ! end ! foll[+3 7#ad7 ,if ! ,secret>y issues fe$back pursuant to section #gjd7;b77#b7 ) respect to in=mation submitt$ 9 response to a report "u section #gjd7;b77#a71 & a report t 0 issu$ "u section #gjd7;b77#a7 is ! only ob/acle to approval ( an application "u ?is subsection or ! ,secret>y det]m9es t ! public heal? b5efit ( approv+ an application "u ?is subsection outweighs any risk to public heal?1 ! ,secret>y %all1 )9 #de days ( notification by ! applicant t necess>y *anges h be5 made to ! e/abli%m5t to address any f9d+s or defici5cies id5tifi$ previ\sly by ! ,secret>y-- 7,a7 re-inspect ! e/abli%m5t ) respect to :i* ! report 0 issu$2 or 7,b7 make a det]m9ation reg>d+ ! response to su* report & review ( su* application4 4