,,ii #aag? ,,congress #b;d ,session ,s4 #ecbb ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,decemb] #bj1 #bjbb,ms4 ,w>r5 7= h]self1 ,mr4 ,br[n1 ,ms4 ,baldw91 ,mr4 ,:iteh\se1 ,mr4 ,van ,holl51 & ,mr4 ,s&]s7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to au?orize ! collection ( supplem5tal paym5ts to increase congressional inve/m5ts 9 m$ical rese>*1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,m$ical ,innovation ,act ( #bjbb4 #b4 ,au?ority to assess & use supplem5tal paym5ts to increase congressional inve/m5ts 9 m$ical rese>* 7a7 ,9 g5]al ,section #cja ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda7 is am5d$ by add+ at ! end ! foll[+3 7i7 ,au?ority ,to assess & use supplem5tal paym5ts ,to increase congressional inve/m5ts 9 m$ical rese>* 7#a7 ,def9itions ,= purposes ( ?is subsection3 7,a7 ,cov]$ blockbu/] drug 7i7 ,9 g5]al ,! t]m cov]$ blockbu/] drug means any product-- 7,i7 = :i* ! cov]$ manufactur] report$ to ! ,securities & ,ex*ange ,commission on a =m1 includ+ =m #aj-,k or =m #bj-;,f1 or is o!rwise det]m9$ by ! ,secret>y to h receiv$1 at lea/ #a1jjj1jjj1jjj 9 net sales 9 ! previ\s cal5d> ye>2 & 7,,ii7 t 0 develop$1 9 :ole or 9 "p1 ?r\gh ,f$]al ,gov]nm5t inve/m5ts 9 m$ical rese>*1 z ! ,secret>y det]m9es 9 accordance ) clause 7ii74 7ii7 ,det]m9ation ( ,f$]al ,gov]nm5t inve/m5t ,9 det]m9+ "u clause 7i77,,ii7 :e!r a product 0 develop$1 9 :ole or 9 "p1 ?r\gh ,f$]al ,gov]nm5t inve/m5ts 9 m$ical rese>*1 ! ,secret>y %all consid] :e!r in=mation includ$ 9 any pat5t t claims ! cov]$ blockbu/] drug or t claims a me?od ( us+ su* cov]$ blockbu/] drug & ) respect to :i* a claim ( pat5t infr+em5t c\ld reasonably be ass]t$ if a p]son n lic5s$ by ! own] engag$ 9 ! manufacture1 use1 or sale ( ! cov]$ blockbu/] drug1 or any elem5t ( ! cov]$ blockbu/] drug-- 7,i7 relates to1 or is bas$ ^u1 prior sci5ce conduct$1 9 :ole or 9 "p1 by a p]son t is or 0 fund$ by ! ,f$]al ,gov]nm5t2 7,,ii7 relates to1 acts ^u1 or is bas$ ^u k ( a signal+ pa?way1 cellul> receptor1 ion *annel1 prote91 ,,dna or ,,rna sequ5ce or mutation1 virus1 or any o!r sci5tific in=mation discov]$1 9 :ole or 9 "p1 ?r\gh rese>* fund$ by ! ,f$]al ,gov]nm5t2 or 7,,iii7 relates to1 or is bas$ ^u1 ?r\gh ! manufactur+ process or te/+ process ( ! cov]$ blockbu/] drug1 te*nology d]iv$1 9 :ole or 9 "p1 ?r\gh rese>* fund$ by ! ,f$]al ,gov]nm5t4 7,b7 ,cov]$ manufactur] ,! t]m cov]$ manufactur] means a p]son-- 7i7 t holds an application approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or a lic5se "u section #cea ( ?is ,act = a cov]$ blockbu/] drug2 or 7ii7 :o is a co-lic5s$ p>tn] ( ! p]son describ$ 9 clause 7i7 t obta9s ! cov]$ blockbu/] drug directly f a p]son describ$ 9 ?is clause or clause 7i74 7,c7 ,cov]$ settlem5t agreem5t 7i7 ,9 g5]al ,! t]m cov]$ settlem5t agreem5t means a settlem5t agreem5t 7includ+ a cons5t decree71 & except z provid$ "u clause 7ii7-- 7,i7 t is betwe5 an ag5cy & a cov]$ manufactur]2 7,,ii7 t relates to-- 7aa7 an alleg$ violation (1 or a p5alty "u1 section #aabh;,a ( ! ,social ,security ,act or section #aabh;,b ( ! ,social ,security ,act2 7bb7 an alleg$ violation "u sub*apt] ,,iii ( *apt] #cg ( title #ca1 ,unit$ ,/ates ,code 7commonly kn[n z ! ,false ,claims ,act72 7cc7 an alleg$ violation "u ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 or 7dd7 an alleg$ violation ( any o!r ,f$]al civil or crim9al law2 & 7,,iii7 "u ! t]ms ( :i* a cov]$ manufactur] is obligat$ 9 an am\nt n less ?an a total ( #a1jjj1jjj1 includ+ civil or crim9al p5alties ) respect to any p>ties1 includ+ gov]nm5tal & private entities4 7ii7 ,exception = settlem5ts n affect+ taxpay]s or public heal? ,! t]m cov]$ settlem5t agreem5t does n include any settlem5t agreem5t t ! ,secret>y det]m9es-- 7,i7 does n involve an alleg$ crim9al violation2 & 7,,ii7 does n relate to-- 7aa7 allegations ( fraud result+1 or pot5tially result+1 9 a loss ( taxpay] doll>s2 or 7bb7 allegations ( conduct hav+ an adv]se impact1 or a pot5tially adv]se impact1 on ! heal? ( ! public4 7,d7 ,p]son ,! t]m p]son has ! mean+ giv5 su* t]m 9 section #bja7;e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 7,e7 ,product ,! t]m product means a drug approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u section #cea1 & subject to section #ejc7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 7#b7 ,supplem5tal paym5ts to increase congressional inve/m5ts 9 m$ical rese>* 7,a7 ,supplem5tal paym5t assessm5t & collection ,beg9n+ ) ! fir/ fiscal ye> t beg9s at lea/ #fj days aft] ! date ( enactm5t ( ! ,m$ical ,innovation ,act ( #bjbb1 & ea* subsequ5t fiscal ye>1 ! ,secret>y %all1 9 accordance ) ?is p>agraph1 assess & collect supplem5tal paym5ts to increase congressional inve/m5ts 9 m$ical rese>* f ea* cov]$ manufactur] describ$ 9 subp>agraph 7,b74 7,b7 ,crit]ia = assess+ paym5ts ,a cov]$ manufactur] t meets bo? ( ! foll[+ crit]ia = a cal5d> ye> 7ref]r$ to 9 ?is subp>agraph & subp>agraph 7,d7 z ! applicable cal5d> ye>7 %all be assess$ a supplem5tal paym5t "u subp>agraph 7,a7 = ! fiscal ye> beg9n+ 9 ! proce$+ cal5d> ye>3 7i7 ,a cov]$ manufactur] t1 dur+ ! #e-ye> p]iod imm$iately prec$+ ! date on :i* ! paym5t is assess$1 b n be=e ! date ( enactm5t ( ! ,m$ical ,innovation ,act ( #bjbb1 ent]$ into a cov]$ settlem5t agreem5t4 7ii7 ,a cov]$ manufactur] t report$ net income ( at lea/ #a1jjj1jjj1jjj to ! ,securities & ,ex*ange ,commission on a =m1 includ+ =m #aj-,k or =m #bj-;,f1 or t ! ,secret>y o!rwise det]m9es to h _h net income ( at lea/ #a1jjj1jjj1jjj-- 7,i7 dur+ ! applicable cal5d> ye>2 or 7,,ii7 dur+ ! cal5d> ye> 9 :i* ! cov]$ manufactur] ent]$ into a cov]$ settlem5t agreem5t1 z describ$ 9 clause 7i74 7,c7 ,paym5t am\nt 7i7 ,9 g5]al ,a cov]$ manufactur] describ$ 9 subp>agraph 7,b7 %all be assess$ a supplem5tal paym5t to increase congressional inve/m5ts 9 m$ical rese>* = a fiscal ye> equal to ! applicable p]c5tage ( ! net income ( ! cov]$ manufactur]1 z report$ or det]m9$ z describ$ 9 subp>agraph 7,b77ii71 = ! previ\s cal5d> ye>1 multipli$ by ! numb] ( cov]$ blockbu/] drugs ( ! cov]$ manufactur] = t ye>4 7ii7 ,applicable p]c5tage ,= purposes ( det]m9+ ! am\nt ( a supplem5tal paym5t "u clause 7i71 ! applicable p]c5tage ( ! net income ( a cov]$ manufactur] is-- 7,i7 #j4ge p]c5t1 9 ! case ( a cov]$ settlem5t agreem5t "u ! t]ms ( :i* ! total obligation ( a cov]$ manufactur] is 9 an am\nt t is less ?an #ejj1jjj1jjj2 7,,ii7 #a p]c5t1 9 ! case ( a cov]$ settlem5t agreem5t "u ! t]ms ( :i* ! total obligation ( a cov]$ manufactur] is 9 an am\nt t is at lea/ #ejj1jjj1jjj b less ?an #a1jjj1jjj1jjj2 or 7,,iii7 #a4e p]c5t1 9 ! case ( a cov]$ settlem5t agreem5t "u ! t]ms ( :i* ! total obligation ( a cov]$ manufactur] is 9 an am\nt t is at lea/ #a1jjj1jjj1jjj4 7,d7 ,annual limitation ,9 ! case ( a cov]$ manufactur] t ent]$ into m ?an #a cov]$ settlem5t agreem5t dur+ an applicable cal5d> ye>1 su* cov]$ manufactur] %all be assess$ a supplem5tal paym5t "u subp>agraph 7,c7 only ) respect to ! cov]$ settlem5t agreem5t "u :i* ! total am\nt obligat$ ( ! cov]$ manufactur]1 z describ$ 9 p>agraph 7#a77;,c77i77,,iii71 is ! highe/4 7,e7 ,publication ( paym5ts ,beg9n+ ) ! fir/ fiscal ye> t beg9s at lea/ #fj days aft] ! date ( enactm5t ( ! ,m$ical ,innovation ,act ( #bjbb1 & n lat] ?an #fj days be=e ! />t ( ea* fiscal ye>1 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/]1 ) respect to ! next fiscal ye>-- 7i7 a li/ ( cov]$ manufactur]s subject to ! paym5t "u ?is p>agraph2 7ii7 a li/ ( ! cov]$ blockbu/] drugs ( ea* su* cov]$ manufactur]2 7iii7 ! total paym5t am\nt assess$ to ea* su* cov]$ manufactur]2 & 7iv7 ! mann] 9 :i* paym5ts assess$ "u ?is p>agraph w be collect$4 7,f7 ,cr$it+ & availability ( supplem5tal paym5ts 7i7 ,9 g5]al ,subject to clause 7ii71 paym5ts au?oriz$ "u ?is p>agraph %all be collect$ & available = obligation only to ! ext5t & 9 ! am\nt provid$ 9 advance 9 appropriations ,acts4 ,su* paym5ts are au?oriz$ to rema9 available until exp5d$4 7ii7 ,collections & appropriations ,acts 7,i7 ,9 g5]al ,! paym5ts au?oriz$ by ?is p>agraph-- 7aa7 subject to subclause 7,,ii71 %all be collect$ & available 9 ea* fiscal ye> 9 an am\nt n to exce$ ! am\nt specifi$ 9 appropriation ,acts1 or o!rwise made available = obligation1 = su* fiscal ye>2 & 7bb7 %all be available to ! ,secret>y to di/ribute1 z describ$ 9 p>agraph 7#c74 7,,ii7 ,provision = e>ly paym5ts ,paym5ts au?oriz$ "u clause 7iii7 = a fiscal ye>1 prior to ! due date = su* paym5ts1 may be accept$ by ! ,secret>y4 7iii7 ,au?orization ( appropriations ,= ! fir/ fiscal ye> t beg9s at lea/ #fj days aft] ! date ( enactm5t ( ! ,m$ical ,innovation ,act ( #bjbb & = ea* subsequ5t fiscal ye>1 !re is au?oriz$ to be appropriat$ = ! purpose ( mak+ di/ributions "u p>agraph 7#c7 to meet ! priorities describ$ 9 p>agraph 7#d71 an am\nt equal to ! total am\nt ( supplem5tal paym5ts assess$ = su* fiscal ye> "u ?is p>agraph4 7,g7 ,remitt+ paym5ts ,a cov]$ manufactur] assess$ a supplem5tal paym5t "u subp>agraph 7,a7 %all remit ! paym5t no lat] ?an ! fir/ bus9ess day on or aft] ,octob] #a ( ea* fiscal ye>1 or ! fir/ bus9ess day aft] ! date ( enactm5t ( an appropriations ,act provid+ = ! collection & obligation ( supplem5tal paym5ts = su* fiscal ye>4 7,h7 ,collection ( assess$ paym5ts t are n remitt$ ,9 any case :]e ! ,secret>y does n receive a supplem5tal paym5t assess$ "u subp>agraph 7,a7 )9 #cj days aft] x is due1 su* supplem5tal paym5t %all be treat$ z a claim ( ! ,unit$ ,/ates ,gov]nm5t subject to sub*apt] ,,ii ( *apt] #cg ( title #ca1 ,unit$ ,/ates ,code4 7,i7 ,supplem5t n supplant ,paym5ts collect$ "u ?is p>agraph %all be us$ to supplem5t & n supplant o!r ,f$]al funds made available to c>ry out ! priorities describ$ 9 p>agraph 7#d74 7#c7 ,di/ribution ( paym5ts to ag5cies to increase congressional inve/m5ts 9 m$ical rese>* 7,a7 ,di/ribution to ag5cies ,subject to subp>agraph 7,c71 = ! purposes describ$ 9 p>agraph 7#d71 ! ,secret>y %all di/ribute ! am\nts appropriat$ "u p>agraph 7#b77;,f77iii7 dur+ a fiscal ye> to-- 7i7 ! ,food & ,drug ,adm9i/ration1 to be us$ 9 accordance ) p>agraph 7#d77;,a72 & 7ii7 ! ,national ,in/itutes ( ,heal? organiz$ "u title ,,iv1 to be us$ 9 accordance ) p>agraph 7#d77;,b74 7,b7 ,di/ribution ratio betwe5 ag5cies ,! am\nt t ! ,secret>y di/ributes to an ag5cy "u subp>agraph 7,a7 dur+ a fiscal ye> %all be> ! same relation to ! total am\nt appropriat$ "u p>agraph 7#b77;,f77iii7 = su* fiscal ye> z ! am\nt ( discretion>y funds appropriat$ to su* ag5cy = su* fiscal ye> be>s to ! total am\nt ( discretion>y fund+ appropriat$ to bo? ag5cies li/$ 9 subp>agraph 7,a7 = su* fiscal ye>4 7,c7 ,ensur+ /able congressional inve/m5ts 9 m$ical rese>* 7i7 ,9 g5]al ,supplem5tal paym5ts collect$ 9 accordance ) p>agraph 7#b7 %all n be di/ribut$ "u subp>agraph 7,a7 = a fiscal ye> unless appropriations to bo? ( ! ag5cies li/$ 9 su* subp>agraph = ! fiscal ye> are equal to or great] ?an appropriations to su* ag5cies = ! prior fiscal ye>4 7ii7 ,delay$ di/ribution ,if1 9 accordance ) clause 7i71 ! ,secret>y does n di/ribute paym5ts collect$ 9 accordance ) p>agraph 7#b7 dur+ any portion ( a fiscal ye>1 &1 at a lat] date 9 su* fiscal ye>1 ! appropriations to ! ag5cies li/$ 9 subp>agraph 7,a7 become equal to or great] ?an ! am\nt ( appropriations = ! prior fiscal ye>1 ! ,secret>y may di/ribute su* paym5t at any "t 9 su* fiscal ye>4 7,d7 ,consid]ations ,9 det]m9+ am\nts appropriat$ = purposes ( subp>agraphs 7,b7 & 7,c7-- 7i7 ! ,secret>y %all n consid] any am\nts appropriat$ 9 accordance ) p>agraph 7#b77;,f77iii72 & 7ii7 ) respect to ! ,food & ,drug ,adm9i/ration1 ! ,secret>y %all n consid] am\nts appropriat$ 9 accordance ) sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7relat+ to us] fees collect$ by ! ,secret>y74 7#d7 ,prioritiz+ urg5t ne$s 9 m$ical rese>* ,! ,secret>y %all ensure t ! paym5ts di/ribut$ "u p>agraph 7#c7 are us$ to meet urg5t ne$s 9 m$ical rese>*1 includ+ priorities z foll[s3 7,a7 ,,fda ,) respect to ! ,food & ,drug ,adm9i/ration1 ! priority use ( ! di/ributions %all include c>ry+ out ! goals ( ! /rategy & implem5tation plan = advanc+ regulatory sci5ce = m$ical products "u section #aabd ( ! ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act 7#ba ,u4,s4,c4 #cic note71 & o!r su* rese>* activities 9 ord] to promote ! public heal? & advance innovation 9 regulatory decisionmak+1 z det]m9$ by ! ,secret>y4 7,b7 ,,nih ,) respect to ! ,national ,in/itutes ( ,heal?1 ! priority use ( ! di/ributions %all include support+-- 7i7 rese>* t fo/]s radical innovation1 includ+-- 7,i7 rese>* on diseases or conditions = :i* treatm5ts exi/ b are inadequate2 7,,ii7 rese>* on diseases or conditions = :i* !re are unmet m$ical ne$s2 7,,iii7 rese>* on diseases = :i* treatm5ts exi/ b ! side effect pr(iles ( su* treatm5ts limit ! !rapeutic pot5tial ( su* treatm5ts2 7,,iv7 rese>* on new approa*es to treatm5t or diagnosis ( a disease us+ a drug1 device1 or !rapy t1 at ! "t ( di/ribution1 is n us$ or is und]us$2 or 7,v7 rese>* to id5tify new biom>k]s2 7ii7 rese>* t advances fundam5tal k & te*nology ev5 if x does n provide imm$iate or ne>-t]m cl9ical or !rapeutic b5efits1 includ+ rese>* & te*nology t advances ! und]/&+ ( bio*emi/ry1 biology1 prote9 sci5ce1 immunology1 g5etics1 virology1 microbiology1 or neurology2 7iii7 rese>* relat$ to diseases t disproportionally acc\nt = ,f$]al heal? c>e sp5d+1 includ+ sp5d+ "u ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act1 ! ,m$icaid program "u title ,,xix ( ! ,social ,security ,act1 ! ,/ate ,*ildr5's ,heal? ,insurance ,program "u title ,,xxi ( ! ,social ,security ,act1 ! ,,tric>e program "u *apt] #ee ( title #aj1 ,unit$ ,/ates ,code1 & ! hospital s]vices & m$ical c>e provid$ ?r\gh ! ,vet]ans' ,adm9i/ration "u *apt]s #ag & #ah ( title #ch1 ,unit$ ,/ates ,code1 & tax cr$its made available ?r\gh ! am5dm5ts to ! ,int]nal ,rev5ue ,code ( #aihf made by ! ,pati5t ,protection & ,af=dable ,c>e ,act 7,public ,law #aaa-adh71 su* z rese>* relat+ to-- 7,i7 diseases t disproportionally impact old] individuals2 7,,ii7 deg5]ative diseases2 & 7,,iii7 *ronic conditions2 & 7iv7 e>ly c>e] sci5ti/s by-- 7,i7 aw>d+ rese>* project grants t support discrete1 specifi$1 circumscrib$ projects to be p]=m$ by ! inve/igator 9 an area repres5t+ ! specific int]e/s & compet5cies ( su* inve/igator1 to inve/igators-- 7aa7 :o are )9 #aj ye>s ( complet+ a t]m9al rese>* degree2 or 7bb7 :o are )9 #aj ye>s ( complet+ a m$ical resid5cy2 7,,ii7 aw>d+ grants t support c>e] developm5t exp]i5ces t lead to e>li] rese>* indep5d5ce2 & 7,,iii7 aw>d+ grants t support innovative tra9+ programs t1 9 addition to sci5tific tra9+1 provide additional tra9+ to enhance employm5t opportunities1 includ+ tra9+ 9 managem5t & bus9ess1 to-- 7aa7 graduate /ud5ts2 7bb7 po/-doctoral fell[s2 7cc7 individuals )9 #aj ye>s ( complet+ a t]m9al rese>* degree2 or 7dd7 individuals )9 #aj ye>s ( complet+ a m$ical resid5cy4 7#e7 ,annual reports 7,a7 ,secret>y ( heal? & human s]vices ,n lat] ?an #ahj cal5d> days be=e ! end ( a fiscal ye> 9 :i* ! ,secret>y has assess$ supplem5tal paym5ts "u p>agraph 7#b71 ! ,secret>y %all submit a report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 :i* %all include a description ( supplem5tal paym5ts assess$1 collect$1 & di/ribut$ "u ?is subsection = su* fiscal ye>1 & a li/ ( ! cov]$ manufactur]s t 7 assess$ supplem5tal paym5ts & ! am\nt ( su* assessm5ts4 7,b7 ,,fda & ,,nih ,= ea* fiscal ye> 9 :i* am\nts are di/ribut$ "u p>agraph 7#c71 ! ,food & ,drug ,adm9i/ration & ! ,national ,in/itutes ( ,heal? %all report on ! use & impact ( su* am\nts 9 ! annual budget submission ( su* entity4 4 7b7 ,effect ( failure ,to remit paym5t ,section #ejb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is am5d$ by add+ at ! end ! foll[+3 7ee7 ,if x is a drug t is a cov]$ blockbu/] drug 7z def9$ 9 section #cja7;i77#a7 ( ! ,public ,heal? ,s]vice ,act7 = :i* any paym5t assess$ "u section #cja7;i77#b7 ( su* ,act has n be5 paid 9 accordance ) su* section1 until su* paym5t is made4 4 7c7 ,sev]ability ,if any provision ( ?is section1 any am5dm5t made by ?is section1 or ! application ( su* provision or am5dm5t to any p]son or circum/ance is held to be uncon/itutional1 ! rema9d] ( ! provisions ( ?is section1 ! am5dm5ts made by ?is section1 & ! application ( su* provisions or am5dm5ts to any p]son or circum/ance %all n be affect$4