,,ii #aaf? ,,congress #a/ ,session ,s4 #ahja ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,june #ab1 #bjai,ms4 ,smi? 7= h]self1 ,ms4 ,klobu*>1 ,mr4 ,blum5?al1 ,mr4 ,udall1 ,mr4 ,br[n1 ,ms4 ,w>r51 ,mr4 ,s&]s1 ,ms4 ,hassan1 ,mr4 ,:iteh\se1 ,mr4 ,m]kley1 ,mr4 ,re$1 ,ms4 ,baldw91 ,mr4 ,book]1 ,mr4 ,durb91 & ,mrs4 ,gillibr&7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,a ,,bill ,to ensure m$ications are af=dable4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,af=dable ,m$ications ,act4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,title ,i--,transp>5cy ,sec4 #aja4 ,drug manufactur] report+4 ,sec4 #ajb4 ,det]m9+ ! public & private b5efit ( copaym5t c\pons & o!r pati5t assi/ance programs4 ,title ,,ii--,access & ,af=dability ,sec4 #bja4 ,negotiat+ fair prices = ,m$ic>e prescription drugs4 ,sec4 #bjb4 ,prescription drug price spikes4 ,sec4 #bjc4 ,import+ af=dable & safe drugs4 ,sec4 #bjd4 ,requir+ drug manufactur]s to provide drug rebates = drugs disp5s$ to l[-income individuals4 ,sec4 #bje4 ,cap on prescription drug co/-%>+4 ,sec4 #bjf4 ,modification ( trade negotiat+ objectives relat+ to intellectual prop]ty rights to ensure access to biological products4 ,title ,,iii--,innovation ,sec4 #cja4 ,innovation inc5tive fund = new & m effective treatm5ts ( bact]ial infections4 ,sec4 #cjb4 ,public fund+ = cl9ical trials4 ,sec4 #cjc4 ,rew>d+ innovative drug developm5t4 ,sec4 #cjd4 ,improv+ program integrity4 ,title ,,iv--,*oice & ,competition ,sec4 #dja4 ,unlawful comp5sation = delay4 ,sec4 #djb4 #ahj-;day exclusivity p]iod am5dm5ts reg>d+ fir/ applicant /atus4 ,sec4 #djc4 #ahj-;day exclusivity p]iod am5dm5ts reg>d+ agreem5ts to def] comm]cial m>ket+4 ,sec4 #djd4 ,increas+ drug competition & prev5t+ drug %ortages4 ,sec4 #dje4 ,disall[ance ( d$uction = adv]tis+ = prescription drugs4 ,sec4 #djf4 ,drug manufactur] duty to disclose drug prices to practition]s4 ,sec4 #djg4 ,exclud+ au?oriz$ g5]ic drugs f calculation ( av]age manufactur] price "u ! ,m$icaid drug rebate program4 ,i ,transp>5cy #aja4 ,drug manufactur] report+ ,"p ,p ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is am5d$ by add+ at ! end ! foll[+3 #cii,v-#g4 ,drug manufactur] report+ 7a7 ,def9itions ,9 ?is section3 7#a7 ,indep5d5t *>ity pati5t assi/ance program ,! t]m indep5d5t *>ity pati5t assi/ance program means any organization describ$ 9 section #eja7;c77#c7 ( ! ,int]nal ,rev5ue ,code ( #aihf & exempt f taxation "u section #eja7;a7 ( su* ,code & :i* is n a private f\ndation 7z def9$ 9 section #eji7;a7 ( su* ,code7 t (f]s pati5t assi/ance4 7#b7 ,manufactur] pati5t assi/ance program ,! t]m manufactur] pati5t assi/ance program means an organization1 includ+ a private f\ndation 7z s def9$71 t is sponsor$ by1 or receives fund+ f1 a manufactur] & t (f]s pati5t assi/ance4 ,su* t]m does n include an indep5d5t *>ity pati5t assi/ance program4 7#c7 ,pati5t assi/ance ,! t]m pati5t assi/ance means assi/ance provid$ to (fset ! co/ ( drugs = individuals4 ,su* t]m includes free products1 c\pons1 rebates1 copay or disc\nt c>ds1 & o!r means ( provid+ assi/ance to individuals relat$ to drug co/s1 z det]m9$ by ! ,secret>y4 7b7 ,report+ on dome/ic sales ,an applicable manufactur] ( an approv$ drug 7includ+ a drug approv$ "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act & a biological product lic5s$ "u subsection 7a7 or 7k7 ( section #cea ( ?is ,act7 %all submit to ! ,secret>y & to ,congress an annual report1 9 su* =mat z ! ,secret>y %all require1 outl9+ ) respect to ! previ\s cal5d> ye> 7except z provid$ 9 subsection 7c77#c77-- 7#a7 ) respect to ea* su* drug-- 7,a7 ! total exp5ditures ( ! manufactur] on-- 7i7 dome/ic & =eign drug rese>* & developm5t1 includ+ an itemiz$ description (-- 7,i7 basic & precl9ical rese>*2 7,,ii7 cl9ical rese>*1 brok5 out by cl9ical trial phase2 7,,iii7 developm5t ( alt]native dosage =ms & /r5g?s = ! drug molecule or comb9ations1 includ+ ! molecule2 7,,iv7 o!r drug developm5t activities1 su* z noncl9ical laboratory /udies & record & report ma9t5ance2 7,v7 pursu+ new or exp&$ indications = su* drug ?r\gh supplem5tal applications "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 7,,vi7 c>ry+ out po/m>ket requirem5ts relat$ to su* drug1 includ+ "u section #eje7o77#c7 ( su* ,act2 7,,vii7 c>ry+ out risk evaluation & mitigation /rategies 9 accordance ) section #eje-a ( su* ,act2 & 7,,viii7 m>ket+ rese>*2 7ii7 co/ ( goods sold1 brok5 out by s\rce & co/ ( ea* compon5t & id5tify+ specific co/s t reflect int]nal transf]s )9 ! manufactur]'s company2 7iii7 acquisition co/s 9 total & p] unit sold1 includ+ co/s = ! pur*ase ( pat5ts & lic5s+2 & 7iv7 m>ket+ & adv]tis+ = ! promotion ( ! drug1 includ+ a breakd[n ( am\nts aim$ at consum]s1 prescrib]s1 manag$ c>e organizations1 & o!rs2 7,b7 ! gross rev5ue1 net rev5ue1 gross pr(it1 & net pr(it to ! manufactur]2 7,c7 ! total numb] ( units ( ! prescription drug t 7 sold 9 int]/ate comm]ce 9 ! mo/ rec5tly complet$ cal5d> ye>2 7,d7 pric+ in=mation1 includ+-- 7i7 :olesale acquisition co/2 7ii7 net av]age price realiz$ by ph>macy b5efit manag]s = drugs provid$ to individuals 9 ! ,unit$ ,/ates1 aft] acc\nt+ = any rebates or o!r paym5ts f ! manufactur] to ! ph>macy b5efit manag] & f ! ph>macy b5efit manag] to ! manufactur]2 & 7iii7 ! net price ( ! drug1 aft] acc\nt+ = disc\nts1 rebates1 or o!r f9ancial consid]ations1 *>g$ to pur*as]s 9 ea* applicable c\ntry ( ! ,organisation = ,economic ,co-op]ation & ,developm5t2 7,e7 in=mation1 includ+ ! doll> value to ! recipi5t ( manufactur] pati5t assi/ance programs (f]$ by ! manufactur] or a manufactur] pati5t assi/ance program sponsor$ by or associat$ ) ! manufactur]1 p] pati5t1 includ+-- 7i7 ! specific =ms ( su* pati5t assi/ance available1 su* z c\pons1 rebates1 disc\nt codes1 or copaym5t c>ds2 7ii7 ! total doll> value ( ea* manufactur] pati5t assi/ance program & ! doll> value ( ea* program to ! pati5t1 includ+ ! basis us$ to assign value to ! manufactur] pati5t assi/ance program2 7iii7 ! duration ( ea* type ( su* pati5t assi/ance available2 & 7iv7 any requirem5ts1 su* z income ?re%olds1 = h[ to qualify = su* pati5t assi/ance2 7,f7 in=mation on usage ( pati5t assi/ance (f]$ by ! manufactur] or a manufactur] pati5t assi/ance program sponsor$ by or associat$ ) ! manufactur]1 includ+-- 7i7 ! numb] ( transactions ( ea* type ( pati5t assi/ance us$2 7ii7 ! numb] ( individuals receiv+ ea* type ( pati5t assi/ance2 7iii7 ! total value ( ea* type ( pati5t assi/ance t 0 us$2 7iv7 ! av]age l5g? ( "t t ea* individual receiv$ ea* type ( pati5t assi/ance2 7v7 ! numb] ( individuals :o 7 discont9u$ f receiv+ ea* type ( pati5t assi/ance2 & 7vi7 complete docum5tation ( ! t]ms & conditions = an individual agree+ to p>ticipate 9 ! program = ea* type ( pati5t assi/ance provid$2 7,g7 any ,f$]al b5efits receiv$ by ! manufactur]1 includ+ ! am\nts & p]iods ( impact = ea* su* b5efit1 includ+ tax cr$its1 pat5t applications t b5efit$ f a ,f$]al grant1 pat5t ext5sions1 exclusivity p]iods1 & o!r ,f$]al b5efits ) respect to su* drug2 & 7,h7 ! p]c5tage ( rese>* & developm5t exp5ditures on-- 7i7 activities conduct$ by ! manufactur]2 7ii7 activities fund$ by ,f$]al entities2 & 7iii7 activities conduct$ by o!r entities su* z academic in/itutions or o!r drug manufactur]s2 7#b7 executive comp5sation = ! *ief executive (fic]1 *ief f9ancial (fic]1 & ! ?ree o!r mo/ highly comp5sat$ executive (fic]s1 includ+ bonuses1 paid by su* manufactur]1 & /ock options affiliat$ ) ! manufactur] t 7 (f]$ to or accru$ by su* (fic]s2 7#c7 any additional in=mation ! manufactur] *ooses to provide relat$ to drug pric+ decisions1 su* z total exp5ditures on drug rese>*1 drug developm5t1 & cl9ical trials on drugs t fail$ to receive approval by ! ,food & ,drug ,adm9i/ration1 a li/ ( drugs & drug prices aga9/ :i* ! manufactur] comp>$ ! applicable drug1 & o!r relevant in=mation2 & 7#d7 any o!r in=mation z ! ,secret>y may require4 7c7 ,submission ( reports 7#a7 ,9 g5]al 7,a7 ,submission by drug manufactur]s ,drug manufactur]s %all submit ! annual reports requir$ "u ?is section submitt$ to ! ,secret>y 9 a usable =mat1 z ! ,secret>y may require4 7,b7 ,collation by ! ,secret>y ,! ,secret>y %all collate ! reports receiv$ z describ$ 9 subp>agraph 7,a7 & submit su* collat$ reports to ,congress1 toge!r ) an analysis ( ! reports by ! ,secret>y t includes-- 7i7 a summ>y ( data f ! reports2 7ii7 consid]ation ( factors su* z tr5ds on rese>* & developm5t co/s1 ,f$]al b5efits1 & manufactur] pati5t assi/ance programs2 & 7iii7 ! relation%ip betwe5 ! factors describ$ 9 clause 7ii7 & prescription drug prices4 7,c7 ,public availability ,! ,secret>y %all make ! reports submitt$ by manufactur]s z describ$ 9 subp>agraph 7,a7 & ! collat$ reports toge!r ) ! analysis ( ! ,secret>y describ$ 9 subp>agraph 7,b7 publicly available1 includ+ by po/+ su* reports to ! int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 9 a se>*able =mat4 ,9 publiciz+ su* reports1 ! ,secret>y may r$act su* propriet>y in=mation z ! ,secret>y det]m9es appropriate4 7#b7 ,s+le reports ,a drug manufactur] %all submit all in=mation requir$ "u subsection 7b7 ) respect to ea* applicable drug1 9 a s+le1 annual report4 7#c7 ,initial report 7,a7 ,9 g5]al ,an applicable drug manufactur] %all submit a report pursuant to ?is section "o ye> aft] ! date ( enactm5t ( ! ,af=dable ,m$ications ,act 7except z provid$ 9 subp>agraph 7,b77 t includes ! in=mation requir$ "u subsection 7b77#a7 ) respect to ea* cal5d> ye> s9ce ! drug = :i* ! report is requir$ 0 approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 lic5s$ "u section #cea ( ?is ,act1 or receiv$ an exemption "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea7;a77#c7 ( ?is ,act1 or ! cal5d> ye> 9 :i* ! manufactur] acquir$ ! drug4 7,b7 ,small bus9esses ,9 ! case ( an applicable drug manufactur] t has few] ?an #ejj employees1 ! initial report describ$ 9 subp>agraph 7,a7 %all be submitt$ by a date det]m9$ by ! ,secret>y1 :i* %all be n e>li] ?an ! date describ$ 9 subp>agraph 7,a7 & n lat] ?an ! date t is #c ye>s aft] ! date ( enactm5t ( ! ,af=dable ,m$ications ,act4 7d7 ,p5alty = noncompliance ,! ,secret>y %all report to ! ,(fice ( ! ,inspector ,g5]al any manufactur]'s failure to submit a complete report z requir$ "u ?is section4 ,any manufactur] t fails to submit a complete report requir$ "u ?is section %all be subject to a civil p5alty ( up to #bjj1jjj = ea* day on :i* ! violation cont9ues4 ,! ,secret>y %all collect ! civil p5alties "u ?is subsection1 & )\t fur!r appropriation1 %all use su* funds to support ! programs "u sections #dji,k & #dhe;,e1 &1 at ! discretion ( ! ,secret>y1 rese>* ( ! ,national ,in/itutes ( ,heal? & o!r activities au?oriz$ "u ! ,af=dable ,m$ications ,act1 includ+ any am5dm5ts made by su* ,act4 4 #ajb4 ,det]m9+ ! public & private b5efit ( copaym5t c\pons & o!r pati5t assi/ance programs 7a7 ,in=mation report+ by indep5d5t *>ity pati5t assi/ance programs ,section #fjcc7;b7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ ! p]iod at ! end ( p>agraph 7#af7 & ins]t+ 1 & & by ins]t+ aft] p>agraph 7#af7 ! foll[+ new p>agraph3 7#ag7 ! total am\nt ( pati5t assi/ance 7)9 ! mean+ ( section #cii,v-#g ( ! ,public ,heal? ,s]vice ,act7 provid$ to individuals :o are prescrib$ drugs manufactur$ by any contributor to ! organization4 4 7b7 ,,gao /udy & report on impact ( copaym5t c\pons & o!r pati5t assi/ance programs on prescription drug pric+ & exp5ditures 7#a7 ,/udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy on ! impact ( copaym5t c\pons & o!r pati5t assi/ance programs on prescription drug pric+ & exp5ditures4 ,su* /udy %all include an analysis ( ! foll[+3 7,a7 ,! ext5t to :i* copaym5t c\pons & pati5t assi/ance programs contribute to inflat$ prescription drug prices & heal? insurance premiums1 includ+ ) respect to-- 7i7 ! ,m$icaid program "u title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq472 7ii7 ! ,m$ic>e program "u title ,,xviii ( su* ,act 7#db ,u4,s4,c4 #acie et seq472 7iii7 ! ,,tric>e program "u *apt] #ee ( title #aj1 ,unit$ ,/ates ,code2 7iv7 heal? c>e "u ! laws adm9i/]$ by ! ,secret>y ( ,vet]ans ,affairs2 7v7 ! comm]cial heal? insurance m>ket2 & 7vi7 ! ca% pay heal? m>ket4 7,b7 ,! ext5t to :i* manufactur]s (f]+ copaym5t c\pons & o!r pati5t assi/ance programs or sponsor+ manufactur] pati5t assi/ance programs report obta9+ tax d$uctions = (f]+ or sponsor+ su* assi/ance 7ei!r z bus9ess exp5ses or *>itable d$uctions71 includ+-- 7i7 ! total report$ value ( ! tax d$uctions claim$ by manufactur]s = (f]+ or sponsor+ pati5t assi/ance programs dur+ ! #aj ye>s prec$+ ! date ( enactm5t ( ?is ,act2 7ii7 a description ( ! me?odology manufactur]s report$ = assign+ a value to ! tax d$uction claim$ by manufactur]s = (f]+ or sponsor+ pati5t assi/ance programs2 & 7iii7 a description ( ! ext5t to :i* ! activities ( indep5d5t *>ity pati5t assi/ance programs1 :i* are sponsor$ by1 or receive fund+ f1 ph>maceutical manufactur]s 7z det]m9$ us+ tax returns1 sales data1 & o!r public disclosures7 provide a f9ancial b5efit to ! manufactur]s t sponsor !m4 7,c7 ,ov]sight t is conduct$ to ensure t indep5d5t *>ity pati5t assi/ance programs adh]e to guidance f ! ,(fice ( ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices on avoid+ wa/e1 fraud1 & abuse4 7#b7 ,def9itions ,9 ?is subsection1 ! t]ms 8pati5t assi/ance01 8indep5d5t *>ity pati5t assi/ance program01 8manufactur]01 & 8manufactur] pati5t assi/ance program0 h ! mean+ giv5 ^? t]ms "u section #cii,v-#g ( ! ,public ,heal? ,s]vice ,act1 z add$ by section #aja4 7#c7 ,report ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report describ+ ! f9d+s ( ! /udy requir$ "u ?is subsection4 ,,ii ,access & ,af=dability #bja4 ,negotiat+ fair prices = ,m$ic>e prescription drugs 7a7 ,negotiat+ fair prices 7#a7 ,9 g5]al ,section #ahfj;,d-#aa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7 is am5d$ by /rik+ subsection 7i7 7relat+ to non9t]f]5ce7 & by ins]t+ ! foll[+3 7i7 ,negotiat+ fair prices ) drug manufactur]s 7#a7 ,9 g5]al ,not)/&+ any o!r provision ( law1 9 fur!rance ( ! goals ( provid+ quality c>e & conta9+ co/s "u ?is "p1 ! ,secret>y %all1 ) respect to applicable cov]$ "p ,d drugs1 & may1 ) respect to o!r cov]$ "p ,d drugs1 negotiate1 us+ ! negotiation te*nique or te*niques t ! ,secret>y det]m9es w maximize sav+s & value to ! gov]nm5t = prescription drug plans & ,,ma-,,pd plans & = plan enrollees 79 a mann] t may be simil> to ,f$]al entities & t may include1 b is n limit$ to1 =mul>ies1 ref]5ce pric+1 disc\nts1 rebates1 o!r price concessions1 & cov]age det]m9ations71 ) drug manufactur]s ! prices t may be *>g$ to ,,pdp sponsors & ,,ma organizations = su* drugs = "p ,d eligible individuals :o are enroll$ 9 a prescription drug plan or 9 an ,,ma-,,pd plan4 ,9 conduct+ su* negotiations1 ! ,secret>y %all consid] ! drug's curr5t price1 initial laun* price1 preval5ce ( disease & usage1 & approv$ indications1 ! numb] ( simil>ly effective alt]native treatm5ts = ea* approv$ use ( ! drug1 ! budget>y impact ( provid+ cov]age "u ?is "p = su* drug = all individuals :o w\ld likely b5efit f ! drug1 evid5ce on ! drug's effectiv5ess & safety comp>$ to simil> drugs1 & ! quality & quantity ( cl9ical data & rigor ( ! applicable process ( approval ( a drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or a biological product "u section #cea ( ! ,public ,heal? ,s]vice ,act4 7#b7 ,use ( l[] ( ,,va or big f\r price if negotiations fail ,if1 aft] attempt+ to negotiate = a price ) respect to a cov]$ "p ,d drug "u p>agraph 7#a7 = a p]iod ( #a ye>1 ! ,secret>y is n successful 9 obta9+ an appropriate price = ! drug 7z det]m9$ by ! ,secret>y71 ! ,secret>y %all e/abli% ! price t may be *>g$ to ,,pdp sponsors & ,,ma organizations = su* drug = "p ,d eligible individuals :o are enroll$ 9 a prescription drug plan or 9 an ,,ma-,,pd plan at an am\nt equal to ! less] (-- 7,a7 ! price paid by ! ,secret>y ( ,vet]ans ,affairs to procure ! drug "u ! laws adm9i/]$ by ! ,secret>y ( ,vet]ans ,affairs2 or 7,b7 ! price paid to procure ! drug "u section #habf ( title #ch1 ,unit$ ,/ates ,code4 7#c7 ,applicable cov]$ "p ,d drug def9$ ,= purposes ( ?is subsection1 ! t]m applicable cov]$ "p ,d drug means a cov]$ "p ,d drug t ! ,secret>y det]m9es to be appropriate = negotiation "u p>agraph 7#a7 bas$ on "o or m ( ! foll[+ factors z appli$ to su* drug3 7,a7 ,sp5d+ on a p] b5efici>y basis4 7,b7 ,! proportion ( total sp5d+ "u ?is title4 7,c7 ,unit price increases ov] ! prec$+ #e ye>s4 7,d7 ,initial laun* price4 7,e7 ,availability ( less exp5sive1 simil>ly effective alt]native treatm5ts4 7,f7 ,/atus ( ! drug z a foll[-on to previ\sly approv$ drugs4 7,g7 ,any o!r crit]ia det]m9$ by ! ,secret>y4 7#d7 ,,pdp sponsors & ,,ma organization may negotiate l[] prices ,no?+ 9 ?is subsection %all be con/ru$ z prev5t+ ! sponsor ( a prescription drug plan1 or an organization (f]+ an ,,ma-,,pd plan1 f obta9+ a disc\nt or r$uction ( ! price = a cov]$ "p ,d drug bel[ ! price negotiat$ "u p>agraph 7#a7 or ! price e/abli%$ "u p>agraph 7#b74 7#e7 ,no effect on exi/+ appeals process ,no?+ 9 ?is subsection %all be con/ru$ to affect ! appeals proc$ures "u subsections 7g7 & 7h7 ( section #ahfj;,d-#d4 4 7#b7 ,effective date ,! am5dm5ts made by ?is subsection %all take effect on ! date ( ! enactm5t ( ?is ,act & %all fir/ apply to negotiations & prices = plan ye>s beg9n+ on ,janu>y #a1 #bjbj4 7b7 ,requirem5t ,to include a l9k to ! ,m$ic>e ,drug ,sp5d+ ,da%bo>d on ! ,m$ic>e ,plan ,f9d] ,beg9n+ n lat] ?an ,janu>y #a1 #bjbj1 ! ,secret>y ( ,heal? & ,human ,s]vices %all ensure t ! ,m$ic>e ,plan ,f9d] on ! ,m$ic>e4gov int]net website includes a l9k to ! ,m$ic>e ,drug ,sp5d+ ,da%bo>d on ! ,,cms4gov int]net website4 ,su* l9k %all be easily accessible on ! ,m$ic>e ,plan ,f9d]4 7c7 ,reports to ,congress 7#a7 ,secret>y ( ,,hhs 7,a7 ,9 g5]al ,n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ?is ,act1 & e #f mon?s !reaft]1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ,congress a report on ! foll[+3 7i7 ,! price negotiations conduct$ by ! ,secret>y "u section #ahfj;,d-#aa7;i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7;i771 z am5d$ by subsection 7a71 includ+ a description (-- 7,i7 h[ su* price negotiations are a*iev+ l[] prices = cov]$ "p ,d drugs 7z def9$ 9 section #ahfj;,d-#b7;e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;e777 = ,m$ic>e b5efici>ies2 7,,ii7 h[ su* l[] prices are pass$ ?r\gh to ,m$ic>e b5efici>ies2 7,,iii7 h[ su* price negotiations are affect+ drug prices 9 ! private m>ket2 & 7,,iv7 h[ su* price negotiations are affect+ ! li/ price ( cov]$ "p ,d drugs4 7ii7 ,data on sp5d+ "u "p ,d ( ! ,m$ic>e program on cov]$ "p ,d drugs1 includ+ data on cov]$ "p ,d drugs )-- 7,i7 sp5d+ on a p] b5efici>y basis t is above ! m$ian sp5d+ on o!r drugs 9 ! same class or above ! m$ian sp5d+ ( o!r drug classes2 & 7,,ii7 high unit co/ increases ov] ! pa/ five ye>s1 especially :]e su* increases are great] ?an ! increases = cov]$ "p ,d drugs 9 g5]al4 7iii7 ,a li/ ( ! cov]$ "p ,d drugs ) no !rapeutic sub/itute & data on sp5d+ "u "p ,d ( ! ,m$ic>e program on su* drugs4 7iv7 ,access to cov]$ "p ,d drugs &1 :]e available1 compliance rates & heal? outcomes associat$ ) compliance rates4 7v7 ,appeals by enrollees ) respect to cov]$ "p ,d drugs n includ$ on plan =mul>ies4 7,b7 ,public availability ( report ,! ,secret>y ( ,heal? & ,human ,s]vices %all publi% on ! int]net website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices a copy ( ea* report submitt$ "u subp>agraph 7,a71 includ+ ! detail$ tables1 figures1 & data publi%$ 9 ! report & its app5dices4 7#b7 ,med,p,a,c 7,a7 ,/udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy on ! price negotiations conduct$ by ! ,secret>y "u section #ahfj;,d-#aa7;i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7;i771 z am5d$ by subsection 7a71 includ+ an analysis (-- 7i7 h[ su* price negotiations are a*iev+ l[] prices = cov]$ "p ,d drugs 7z def9$ 9 section #ahfj;,d-#b7;e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;e777 = ,m$ic>e b5efici>ies2 7ii7 :o is b5efit+ f su* l[] prices1 su* z ,m$ic>e b5efici>ies1 ! ,f$]al ,gov]nm5t1 ,/ates1 prescription drug plans & ,,ma-,,pd plans1 or o!r entities2 7iii7 h[ su* price negotiations are a factor affect+ drug prices 9 ! private m>ket2 & 7iv7 h[ su* price negotiations are a factor affect+ ! li/ price ( cov]$ "p ,d drugs4 7,b7 ,report ,n lat] ?an ,janu>y #a1 #bjbb1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report on ! /udy conduct$ "u subp>agraph 7,a71 toge!r ) recomm5dations = improv+ su* price negotiations4 7d7 ,,cmi te/+ ( negotiat+ drug & biological prices ,to improve value ,section #aaae;,a7b77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acae;a7b77#b77 is am5d$-- 7#a7 9 subp>agraph 7,a71 by add+ at ! end ! foll[+ new s5t5ce3 ,! models select$ "u ?is subp>agraph %all include at lea/ ?ree ( ! models describ$ 9 subp>agraph 7,d71 :i* %all be implem5t$ by n lat] ?an #ah mon?s aft] ! date ( ! enactm5t ( ! ,af=dable ,m$ications ,act2 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,d7 ,models ( negotiat+ drug & biological prices to improve value ,! models describ$ 9 ?is subp>agraph are ! foll[+ models = negotiat+ drug & biological prices "u ! applicable titles 7includ+ "u bo? p>ts ,b & ,d ( title ,,xviii7 9 ord] to improve ! value ( paym5ts = su* drugs & biologicals "u su* titles3 7i7 ,disc\nt+ or elim9at+ pati5t co/-%>+ on high-value drugs & biologicals4 7ii7 ,value-bas$ =mul>ies4 7iii7 ,indications-bas$ pric+4 7iv7 ,ref]5ce pric+4 7v7 ,risk-%>+ agreem5ts bas$ on outcomes4 7vi7 ,pric+ bas$ on comp>ative effectiv5ess rese>*4 7vii7 ,episode-bas$ paym5ts = *emo!rapy & o!r conditions det]m9$ appropriate by ! ,secret>y4 7viii7 ,alt]native ways ( pay+ = drugs & biologicals "u "p ,b ( title ,,xviii4 7ix7 ,o!r models det]m9$ appropriate by ! ,secret>y4 4 #bjb4 ,prescription drug price spikes 7a7 ,id5tification ( prescription drug price spikes 7#a7 ,def9itions ,9 ?is subsection3 7,a7 ,applicable entity ,! t]m applicable entity means ! hold] ( an application approv$ "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or ( a lic5se issu$ "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 = a drug describ$ 9 p>agraph 7#e77;,a74 7,b7 ,av]age manufactur] price ,! t]m av]age manufactur] price-- 7i7 has ! same mean+ giv5 su* t]m "u section #aibg7k77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#a772 or 7ii7 ) respect to a drug = :i* !re is no av]age manufactur] price z s def9$1 su* t]m %all mean ! :olesale acquisition co/ ( ! drug4 7,c7 ,comm]ce ,! t]m comm]ce has ! mean+ giv5 su* t]m 9 section #d ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #dd74 7,d7 ,inspector ,g5]al ,! t]m ,inspector ,g5]al means ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7,e7 ,prescription drug 7i7 ,9 g5]al ,! t]m prescription drug means any drug 7z def9$ 9 section #bja7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g7771 includ+ a comb9ation product ^: prim>y mode ( action is det]m9$ "u section #ejc7;g7 ( su* ,act 7#ba ,u4,s4,c4 #cec7;g77 to be t ( a drug1 & t-- 7,i7 is subject to section #ejc7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;b77#a772 & 7,,ii7 is cov]$ by a ,f$]al heal? c>e program 7z def9$ 9 section #aabh;,b7f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;b7f7774 7ii7 ,treatm5t ( re=mulat$ drugs ,= purposes ( ?is subsection1 a prescription drug ) respect to :i* ! ,secret>y ( ,heal? & ,human ,s]vices has approv$ any m9or re=mulation t does n produce a mean+ful !rapeutic b5efit1 ! drug t 0 approv$ prior to any su* re=mulation & ! drug ) any su* re=mulation %all be consid]$ "o prescription drug4 7,f7 ,price spike 7i7 ,9 g5]al ,! t]m price spike means an increase 9 ! av]age manufactur] price 9 comm]ce ( a prescription drug = :i* ! price spike p]c5tage is equal to or great] ?an applicable price increase all[ance4 7ii7 ,price spike p]c5tage ,! price spike p]c5tage is ! p]c5tage 7if any7 by :i*-- 7,i7 ! av]age manufactur] price ( a prescription drug 9 comm]ce = ! cal5d> ye>2 exce$s 7,,ii7 ! av]age manufactur] price ( su* prescription drug 9 comm]ce = ! cal5d> ye> prec$+ su* ye>4 7iii7 ,applicable price increase all[ance ,! applicable price increase all[ance = any cal5d> ye> is ! p]c5tage 7r\nd$ to ! ne>e/ "o-t5? ( #a p]c5t7 by :i* ! ,c-,,cpi-,u 7z def9$ 9 section #a7;f77#f7 ( ! ,int]nal ,rev5ue ,code ( #aihf7 = t ye> exce$s ! ,c-,,cpi-,u = ! prec$+ cal5d> ye>4 7,g7 ,price spike rev5ue 7i7 ,9 g5]al ,! price spike rev5ue = any cal5d> ye> is an am\nt equal to-- 7,i7 ! gross price spike rev5ue2 m9us 7,,ii7 ! adju/m5t am\nt4 7ii7 ,gross price spike rev5ue ,! gross price spike rev5ue = any cal5d> ye> is an am\nt equal to ! product (-- 7,i7 an am\nt equal to ! diff]5ce betwe5 subclause 7,i7 ( subp>agraph 7,f77ii7 & subclause 7,,ii7 ( su* subp>agraph2 & 7,,ii7 ! total numb] ( units ( ! prescription drug :i* 7 sold 9 comm]ce 9 su* cal5d> ye>4 7iii7 ,adju/m5t am\nt ,! adju/m5t am\nt is ! am\nt1 if any1 ( ! gross price spike rev5ue :i* ! ,inspector ,g5]al has det]m9$ is due solely to an increase 9 ! co/ ( ! inputs necess>y to manufacture ! prescription drug subject to ! price spike4 7#b7 ,submission by ph>maceutical companies ( in=mation to ,inspector ,g5]al 7,a7 ,9 g5]al ,= ea* prescription drug1 ! applicable entity %all submit to ! ,inspector ,g5]al a qu>t]ly report t includes ! foll[+3 7i7 ,= ea* prescription drug ( ! applicable entity-- 7,i7 ! total numb] ( units ( ! prescription drug :i* 7 sold 9 comm]ce 9 ! prec$+ cal5d> qu>t]2 7,,ii7 ! av]age & m$ian price p] unit ( su* prescription drug 9 comm]ce 9 ! prec$+ cal5d> qu>t]1 disaggregat$ by mon?2 & 7,,iii7 ! gross rev5ues f sales ( su* prescription drug 9 comm]ce 9 ! prec$+ cal5d> qu>t]4 7ii7 ,su* in=mation relat$ to increas$ input co/s or public heal? consid]ations z ! applicable entity may wi% ! ,inspector ,g5]al to consid] 9 mak+ a det]m9ation "u subclause 7,,ii7 ( p>agraph 7#c77;,b77ii7 or an assessm5t 9 subclause 7,,iii7 ( su* p>agraph = ! prec$+ cal5d> qu>t]4 7iii7 ,su* in=mation relat$ to any anticipat$ increas$ input co/s = ! subsequ5t cal5d> qu>t] z ! applicable entity may wi% ! ,inspector ,g5]al to consid] 9 mak+ a det]m9ation "u subclause 7,,ii7 ( p>agraph 7#c77;,b77ii7 or an assessm5t 9 subclause 7,,iii7 ( su* p>agraph = su* cal5d> qu>t]4 7,b7 ,p5alty = failure to submit 7i7 ,9 g5]al ,an applicable entity describ$ 9 subp>agraph 7,a7 t fails to submit in=mation to ! ,inspector ,g5]al reg>d+ a prescription drug1 z requir$ by su* subp>agraph1 be=e ! date specifi$ 9 subp>agraph 7,c7 %all be liable = a civil p5alty1 z det]m9$ "u clause 7ii74 7ii7 ,am\nt ( p5alty ,! am\nt ( ! civil p5alty %all be equal to ! product (-- 7,i7 an am\nt1 z det]m9$ appropriate by ! ,inspector ,g5]al1 :i* is-- 7aa7 n less ?an #j4e p]c5t ( ! gross rev5ues f sales ( ! prescription drug describ$ 9 clause 7i7 = ! prec$+ cal5d> ye>1 & 7bb7 n great] ?an #a p]c5t ( ! gross rev5ues f sales ( su* prescription drug = ! prec$+ cal5d> ye>1 & 7,,ii7 ! numb] ( days 9 ! p]iod betwe5-- 7aa7 ! applicable date specifi$ 9 subp>agraph 7,c71 & 7bb7 ! date on :i* ! ,inspector ,g5]al receives ! in=mation describ$ 9 subp>agraph 7,a7 f ! applicable entity4 7,c7 ,submission deadl9e ,an applicable entity %all submit ea* qu>t]ly report describ$ 9 subp>agraph 7,a7 n lat] ?an ,janu>y #ag1 ,april #ah1 ,june #ae1 & ,septemb] #ae ( ea* cal5d> ye>4 7#c7 ,assessm5t by ,inspector ,g5]al 7,a7 ,9 g5]al ,n lat] ?an ! la/ day 9 ,febru>y ( ea* ye>1 ! ,inspector ,g5]al1 9 consultation ) o!r relevant ,f$]al ag5cies 7includ+ ! ,f$]al ,trade ,commission71 %all-- 7i7 complete an assessm5t ( ! in=mation ! ,inspector ,g5]al receiv$ pursuant to p>agraph 7#b77;,a7 ) respect to sales ( prescription drugs 9 ! prec$+ cal5d> ye>2 & 7ii7 9 ! case ( any prescription drug :i* satisfies ! conditions describ$ 9 subp>agraph 7,a7 or 7,b7 ( p>agraph 7#d71 submit a recomm5dation to ! ,secret>y ( ,heal? & ,human ,s]vices t su* drug be exempt$ f application ( ! tax impos$ "u section #daib ( ! ,int]nal ,rev5ue ,code ( #aihf 7z add$ by subsection 7b7 ( ?is section7 = su* ye>4 7,b7 ,elem5ts ,! assessm5t requir$ by subp>agraph 7,a7 %all include ! foll[+3 7i7 ,id5tification ( ea* price spike relat+ to a prescription drug 9 ! prec$+ cal5d> ye>4 7ii7 ,= ea* price spike id5tifi$ "u clause 7i7-- 7,i7 a det]m9ation ( ! price spike rev5ue2 7,,ii7 a det]m9ation reg>d+ ! accuracy ( ! in=mation submitt$ by ! applicable entity reg>d+ increas$ input co/s2 & 7,,iii7 an assessm5t ( ! rationale ( ! applicable entity = ! price spike4 7#d7 ,exemption ( c]ta9 drugs 7,a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices1 ^u recomm5dation ( ! ,inspector ,g5]al pursuant to p>agraph 7#c77;,a77ii71 may exempt any prescription drug :i* has be5 subject to a price spike dur+ ! prec$+ cal5d> ye> f application ( ! tax impos$ "u section #daib ( ! ,int]nal ,rev5ue ,code ( #aihf = su* ye>1 if ! ,secret>y det]m9es t-- 7i7 bas$ on in=mation submitt$ pursuant to p>agraph 7#b77;,a77ii71 a =-cause price increase exemption %\ld apply2 or 7ii7 7,i7 ! prescription drug :i* has be5 subject to a price spike has an av]age manufactur] price ( n great] ?an #aj = a #cj-;day supply2 & 7,,ii7 su* drug is m>ket$ by n less ?an ?ree o!r hold]s ( applications approv$ "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 :]e su* applications approv$ "u su* subsection 7j7 use z a ref]5ce drug ! drug s approv$ "u su* subsection 7c74 7,b7 ,cl>ification ,9 consid]+1 "u subp>agraph 7,a77i71 in=mation submitt$ pursuant to p>agraph 7#b77;,a77ii71 ! ,secret>y-- 7i7 has ! discretion to det]m9e t su* in=mation does n w>rant a =-cause price increase exemption2 & 7ii7 %all exclude f su* consid]ation any in=mation submitt$ by ! applicable entity ?reat5+ to curtail or limit production ( ! prescription drug if ! ,secret>y does n grant an exemption f ! application ( ! tax "u section #daib ( ! ,int]nal ,rev5ue ,code ( #aihf4 7#e7 ,inspector ,g5]al report to ,int]nal ,rev5ue ,s]vice 7,a7 ,9 g5]al ,subject to subp>agraph 7,c71 n lat] ?an ! la/ day 9 ,febru>y ( ea* ye>1 ! ,inspector ,g5]al %all transmit to ! ,int]nal ,rev5ue ,s]vice a report on ! f9d+s ( ! ,inspector ,g5]al ) respect to ! in=mation ! ,inspector ,g5]al receiv$ "u p>agraph 7#b77;,a7 ) respect to ! prec$+ cal5d> ye> & ! assessm5t c>ri$ out by ! ,inspector ,g5]al "u p>agraph 7#c77;,a7 ) respect to su* in=mation4 7,b7 ,cont5ts ,! report transmitt$ "u subp>agraph 7,a7 %all include ! foll[+3 7i7 ,! in=mation receiv$ "u p>agraph 7#b77;,a7 ) respect to ! prec$+ cal5d> ye>4 7ii7 ,! price spikes id5tifi$ "u clause 7i7 ( p>agraph 7#c77;,b74 7iii7 ,! price spike rev5ue det]m9ations made "u clause 7ii77,i7 ( su* p>agraph4 7iv7 ,! det]m9ations & assessm5ts made "u subclauses 7,,ii7 & 7,,iii7 ( clause 7ii7 ( su* p>agraph4 7,c7 ,notice & opportunity = he>+ 7i7 ,9 g5]al ,no report %all be transmitt$ to ! ,int]nal ,rev5ue ,s]vice "u subp>agraph 7,a7 9 reg>ds to a prescription drug unless ! ,inspector ,g5]al has provid$ ! applicable entity )-- 7,i7 ! assessm5t ( su* drug "u p>agraph 7#c77;,a72 & 7,,ii7 notice ( _! "r to a he>+ 9 reg>ds to su* assessm5t4 7ii7 ,notice ,! notice requir$ "u clause 7i7 %all be provid$ to ! applicable entity n lat] ?an #cj days aft] completion ( ! assessm5t "u p>agraph 7#c77;,a74 7iii7 ,reque/ = he>+ ,subject to clause 7v71 an applicable entity may reque/ a he>+ be=e ! ,secret>y ( ,heal? & ,human ,s]vices n lat] ?an #cj days aft] ! date on :i* ! notice "u clause 7ii7 is receiv$4 7iv7 ,completion ( he>+ ,9 ! case ( an applicable entity :i* reque/s a he>+ pursuant to clause 7iii71 ! ,secret>y ( ,heal? & ,human ,s]vices %all1 n lat] ?an #ab mon?s aft] ! date on :i* ! assessm5t "u p>agraph 7#c77;,a7 0 complet$ by ! ,inspector ,g5]al-- 7,i7 make a f9al det]m9ation 9 reg>ds ! accuracy ( su* assessm5t2 & 7,,ii7 provide ! report describ$ 9 subp>agraph 7,b7 to ! ,int]nal ,rev5ue ,s]vice4 7v7 ,limitation ,an applicable entity may reque/ a he>+ "u clause 7iii7 ) respect to a p>ticul> prescription drug only once )9 a #e-ye> p]iod4 7,d7 ,publication 7i7 ,9 g5]al ,n lat] ?an ! la/ day 9 ,febru>y ( ea* ye>1 subject to clause 7ii71 ! ,inspector ,g5]al %all make ! report transmitt$ "u subp>agraph 7,a7 available to ! public1 includ+ on ! int]net website ( ! ,inspector ,g5]al4 7ii7 ,propriet>y in=mation ,! ,inspector ,g5]al %all ensure t any in=mation made public 9 accordance ) clause 7i7 excludes trade secrets & confid5tial comm]cial in=mation4 7#f7 ,notification ,! ,secret>y ( ! ,treasury1 9 conjunction ) ! ,inspector ,g5]al1 %all notify1 at su* "t & 9 su* mann] z ! ,secret>y ( ! ,treasury %all provide1 ea* applicable entity 9 reg>d to any prescription drug :i* has be5 det]m9$ to h be5 subject to a price spike dur+ ! prec$+ cal5d> ye> & ! am\nt ( ! tax impos$ on su* applicable entity pursuant to section #daib ( ! ,int]nal ,rev5ue ,code ( #aihf4 7b7 ,excise tax on prescription drugs subject to price spikes 7#a7 ,9 g5]al ,sub*apt] ,e ( *apt] #cb ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new section3 #daib4 ,prescription drugs subject to price spikes 7a7 ,imposition ( tax 7#a7 ,9 g5]al ,subject to p>agraph 7#c71 = ea* taxable prescription drug sold by an applicable entity dur+ ! cal5d> ye>1 !re is h]eby impos$ on su* entity a tax equal to ! great] (-- 7,a7 ! annual price spike tax = su* prescription drug1 or 7,b7 subject to p>agraph 7#b71 ! cumulative price spike tax = su* prescription drug4 7#b7 ,limitation ,9 ! case ( a taxable prescription drug = :i* ! applicable p]iod 7z det]m9$ "u subsection 7c77#b77;,e77i77 is less ?an #b cal5d> ye>s1 ! cumulative price spike tax %all n apply4 7#c7 ,exemption ,= any cal5d> ye> 9 :i* ! ,secret>y ( ,heal? & ,human ,s]vices has provid$ an exemption = a taxable prescription drug pursuant to section #bjb7;a77#d7 ( ! ,af=dable ,m$ications ,act1 ! am\nt ( ! tax det]m9$ "u p>agraph 7#a7 = su* drug or device = su* cal5d> ye> %all be r$uc$ to z]o4 7b7 ,annual price spike tax 7#a7 ,9 g5]al ,! am\nt ( ! annual price spike tax %all be equal to ! applicable p]c5tage ( ! price spike rev5ue receiv$ by ! applicable entity on ! sale ( ! taxable prescription drug dur+ ! cal5d> ye>4 7#b7 ,applicable p]c5tage ,= purposes ( p>agraph 7#a71 ! applicable p]c5tage %all be equal to-- 7,a7 9 ! case ( a taxable prescription drug :i* has be5 subject to a price spike p]c5tage great] ?an ! applicable price increase all[ance 7z def9$ 9 section #bjb7;a77#a77;,f77iii7 ( ! ,af=dable ,m$ications ,act7 b less ?an #ae p]c5t1 #ej p]c5t1 7,b7 9 ! case ( a taxable prescription drug :i* has be5 subject to a price spike p]c5tage equal to or great] ?an #ae p]c5t b less ?an #bj p]c5t1 #ge p]c5t1 & 7,c7 9 ! case ( a taxable prescription drug :i* has be5 subject to a price spike p]c5tage equal to or great] ?an #bj p]c5t1 #ajj p]c5t4 7c7 ,cumulative price spike tax 7#a7 ,9 g5]al ,! am\nt ( ! cumulative price spike tax %all be equal to ! applicable p]c5tage ( ! cumulative price spike rev5ue receiv$ by ! applicable entity on ! sale ( ! taxable prescription drug dur+ ! cal5d> ye>4 7#b7 ,applicable p]c5tage 7,a7 ,9 g5]al ,= purposes ( p>agraph 7#a71 ! applicable p]c5tage %all be equal to-- 7i7 9 ! case ( a taxable prescription drug :i* has be5 subject to a cumulative price spike p]c5tage great] ?an ! cumulative price increase all[ance b less ?an ! fir/ multi-ye> p]c5tage1 #ej p]c5t1 7ii7 9 ! case ( a taxable prescription drug :i* has be5 subject to a cumulative price spike p]c5tage equal to or great] ?an ! fir/ multi-ye> p]c5tage b less ?an ! second multi-ye> p]c5tage1 #ge p]c5t1 & 7iii7 9 ! case ( a taxable prescription drug :i* has be5 subject to a cumulative price spike p]c5tage equal to or great] ?an ! second multi-ye> p]c5tage1 #ajj p]c5t4 7,b7 ,cumulative price spike p]c5tage ,! cumulative price spike p]c5tage is ! p]c5tage 7if any7 by :i*-- 7i7 ! av]age manufactur] price ( ! taxable prescription drug 9 comm]ce = ! prec$+ cal5d> ye>1 exce$s 7ii7 ! av]age manufactur] price ( su* prescription drug 9 comm]ce = ! base ye>4 7,c7 ,cumulative price increase all[ance ,= purposes ( clause 7i7 ( subp>agraph 7,a71 ! cumulative price increase all[ance = any cal5d> ye> is ! p]c5tage 7r\nd$ to ! ne>e/ "o-t5? ( #a p]c5t7 by :i* ! ,c-,,cpi-,u 7z def9$ 9 section #a7;f77#f77 = t ye> exce$s ! ,c-,,cpi-,u = ! base ye>4 7,d7 ,multi-ye> p]c5tages ,= purposes ( subp>agraph 7,a71 ! fir/ multi-ye> p]c5tage & second multi-ye> p]c5tage %all be det]m9$ 9 accordance ) ! foll[+ table3 ,numb] ( ye>s 9 applicable period,first multi-ye> percentage,second multi-ye> p]c5tage#b ye>s#ag4ebb4ec ye>s#bjbed ye>s#bb4ebg4ee ye>s#becj4 7,e7 ,applicable p]iod & base ye> 7i7 ,applicable p]iod ,! applicable p]iod %all be ! less] (-- 7,i7 ! #e prec$+ cal5d> ye>s1 7,,ii7 all cal5d> ye>s beg9n+ aft] ! date ( enactm5t ( ?is section1 or 7,,iii7 all cal5d> ye>s 9 :i* ! taxable prescription drug 0 sold 9 comm]ce4 7ii7 ,base ye> ,! base ye> %all be ! cal5d> ye> imm$iately prec$+ ! applicable p]iod4 7#c7 ,cumulative price spike rev5ue ,= purposes ( p>agraph 7#a71 ! cumulative price spike rev5ue = any taxable prescription drug %all be an am\nt equal to-- 7,a7 an am\nt equal to ! product (-- 7i7 an am\nt 7n less ?an z]o7 equal to-- 7,i7 ! av]age manufactur] price ( su* prescription drug 9 comm]ce = ! prec$+ cal5d> ye>1 m9us 7,,ii7 ! av]age manufactur] price ( su* prescription drug 9 comm]ce = ! base ye>1 & 7ii7 ! total numb] ( units ( su* prescription drug :i* 7 sold 9 comm]ce 9 ! prec$+ cal5d> ye>1 m9us 7,b7 an am\nt equal to ! sum ( ! adju/m5t am\nts1 if any1 det]m9$ "u section #bjb7;a77#a77;,g77iii7 ( ! ,af=dable ,m$ications ,act = ea* cal5d> ye> dur+ ! applicable p]iod4 7d7 ,def9itions ,= purposes ( ?is section-- 7#a7 ,taxable prescription drug ,! t]m taxable prescription drug means a prescription drug 7z def9$ 9 section #bjb7;a77#a77;,e7 ( ! ,af=dable ,m$ications ,act7 :i* has be5 id5tifi$ by ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 "u section #bjb7;a77#c77;,b77i7 ( su* ,act1 z be+ subject to a price spike4 7#b7 ,o!r t]ms ,! t]ms applicable entity1 av]age manufactur] price1 price spike1 price spike p]c5tage1 & price spike rev5ue h ! same mean+ giv5 su* t]ms "u section #bjb7;a77#a7 ( ! ,af=dable ,m$ications ,act4 4 7#b7 ,cl]ical am5dm5ts 7,a7 ,! head+ ( sub*apt] ,e ( *apt] #cb ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ ,m$ical devices & ins]t+ ,c]ta9 m$ical devices & prescription drugs4 7,b7 ,! table ( sub*apt]s = *apt] #cb ( su* ,code is am5d$ by /rik+ ! item relat+ to sub*apt] ,e & ins]t+ ! foll[+ new item3 ,sub*apt] ,e4 ,c]ta9 m$ical devices & prescription drugs 4 7#c7 ,! table ( sections = sub*apt] ,e ( *apt] #cb ( su* ,code is am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #daib4 ,prescription drugs subject to price spikes4 4 7#d7 ,effective date ,! am5dm5ts made by ?is section %all apply to sales aft] ! date ( ! enactm5t ( ?is ,act4 7c7 ,rev5ues collect$ ,!re are au?oriz$ to be appropriat$ to ! ,secret>y ( ,heal? & ,human ,s]vices su* sums z are equal to any increase 9 rev5ue to ! ,treasury by reason ( ! provisions ( ?is section or ! am5dm5ts made by ?is section = ! purposes (-- 7#a7 fund+ or conduct+ rese>* on ! economic & policy implications ( price patt]ns ( prescription drugs2 7#b7 increas+ am\nts available to ! ,national ,in/itutes ( ,heal? = rese>* & developm5t ( drugs2 7#c7 r$uc+ prescription drug co/-%>+ = pati5ts2 or 7#d7 r$uc+ heal? insurance premiums4 #bjc4 ,import+ af=dable & safe drugs 7a7 ,9 g5]al ,section #hjd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #chd7 is am5d$ to read z foll[s3 #hjd4 ,importation ( safe & af=dable drugs by :olesale di/ributors1 ph>macies1 & individuals 7a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,af=dable ,m$ications ,act1 ! ,secret>y %all promulgate regulations p]mitt+ ! importation ( qualify+ prescription drugs into ! ,unit$ ,/ates1 9 accordance ) ?is section4 7b7 ,def9itions ,= purposes ( ?is section3 7#a7 ,c]tifi$ =eign sell] ,! t]m c]tifi$ =eign sell] means a lic5s$ =eign ph>macy or =eign :olesale di/ributor t ! ,secret>y c]tifies "u subsection 7d77#a77;,b71 t pays ! fee requir$ "u subsection 7d77#a77;,c71 & t is includ$ on ! li/ describ$ 9 subsection 7c74 7#b7 ,=eign :olesale di/ributor ,! t]m =eign :olesale di/ributor means a p]son 7o!r ?an a manufactur]1 a manufactur]'s co-lic5s$ p>tn]1 a ?ird-p>ty logi/ics provid]1 or a repackag]7 engag$ 9 :olesale di/ribution4 7#c7 ,import] ,! t]m import] means a disp5s] 7z def9$ 9 section #eha7c77 or :olesale di/ributor regi/]$ "u section #ejc7;e7 :o imports prescription drugs into ! ,unit$ ,/ates 9 accordance ) ?is section4 7#d7 ,lic5s$ =eign ph>macy ,! t]m lic5s$ =eign ph>macy means a ph>macy locat$ 9 ,canada1 or subject to subsection 7e71 ano!r applicable c\ntry1 t-- 7,a7 op]ates 9 accordance ) applicable ph>macy /&>ds set =? by ! prov9cial ph>macy rules & regulations enact$ 9 ,canada1 or1 subject to subsection 7e71 su* applicable rules & regulations ( ! p]mitt$ c\ntry 9 :i* su* sell] is locat$2 & 7,b7 is lic5s$ to op]ate & disp5se prescription drugs to individuals 9 ,canada1 or1 subject to subsection 7e71 ! p]mitt$ c\ntry 9 :i* ! ph>macy is locat$4 7#e7 ,qualify+ prescription drug ,! t]m qualify+ prescription drug-- 7,a7 means a prescription drug t-- 7i7 is approv$ = use 9 pati5ts1 & m>ket$1 9 ,canada1 or subject to subsection 7e71 approv$ = use 9 pati5ts1 & m>ket$1 9 ano!r p]mitt$ c\ntry2 7ii7 is manufactur$ 9 a facility regi/]$ "u subsection 7b77#a7 or 7i7 ( section #eaj t is 9 compliance ) good manufactur+ practices regulations ( ! ,food & ,drug ,adm9i/ration2 7iii7 has ! same active +r$i5t or +r$i5ts1 r\te ( adm9i/ration1 & /r5g? z a prescription drug approv$ "u *apt] ,v1 or1 = purposes ( subp>agraph 7,b77iv71 is biosimil> to an approv$ biological product & has ! same r\te ( adm9i/ration & /r5g? z ! approv$ biological product2 & 7iv7 is label$ 9 accordance )-- 7,i7 ! laws ( ,canada1 or ano!r c\ntry f :i* importation is p]mitt$ pursuant to subsection 7e72 & 7,,ii7 ! requirem5ts promulgat$ by ! ,secret>y1 :i* %all include label+ 9 ,engli%2 7,b7 ) respect to import]s only1 includes-- 7i7 p]itoneal dialysis solution2 7ii7 insul92 7iii7 a drug = :i* a risk evaluation & mitigation /rategy is requir$ "u section #eje-a2 7iv7 biological products1 z def9$ 9 section #cea ( ! ,public ,heal? ,s]vice ,act t are prote9s 7except any *emically syn!siz$ polypeptides7 or analog\s products2 & 7v7 intrav5\sly infus$ drugs2 & 7,c7 does n include-- 7i7 a controll$ sub/ance 7z def9$ 9 section #ajb ( ! ,controll$ ,sub/ances ,act72 7ii7 an ane/hetic drug inhal$ dur+ surg]y2 or 7iii7 a comp\nd$ drug4 7#f7 ,valid prescription ,! t]m valid prescription means a prescription t is issu$ = a legitimate m$ical purpose 9 ! usual c\rse ( pr(essional practice by-- 7,a7 a practition] :o has conduct$ at lea/ "o 9-p]son m$ical evaluation ( ! pati5t2 or 7,b7 a cov]+ practition]4 7c7 ,publication ( c]tifi$ =eign sell]s ,! ,secret>y %all publi% on a d$icat$ int]net website a li/ ( c]tifi$ =eign sell]s1 includ+ ! int]net website address1 physical address1 & telephone numb] ( ea* su* c]tifi$ =eign sell]4 7d7 ,additional crit]ia 7#a7 ,c]tifi$ =eign sell]s 7,a7 ,9 g5]al ,to be a c]tifi$ =eign sell]1 su* sell] %all-- 7i7 be c]tifi$ by ! ,secret>y 9 accordance ) subp>agraph 7,b72 7ii7 pay ! regi/ration fee e/abli%$ "u subp>agraph 7,c72 & 7iii7 sell only qualify+ prescription drugs to import]s or individuals :o import prescription drugs into ! ,unit$ ,/ates 9 accordance ) ?is section4 7,b7 ,c]tification ,to be a c]tifi$ =eign sell]1 ! ,secret>y %all c]tify t su* sell]-- 7i7 is a =eign :olesale di/ributor or lic5s$ =eign ph>macy op]at+ an e/abli%m5t1 :i* may include an onl9e =eign ph>macy1 t is locat$ 9 ,canada1 or1 subject to subsection 7e71 ano!r p]mitt$ c\ntry2 7ii7 is engag$ 9 ! di/ribution or disp5s+ ( a prescription drug t is import$ or (f]$ = importation into ! ,unit$ ,/ates2 7iii7 has be5 9 exi/5ce = a p]iod ( at lea/ #e ye>s prec$+ ! date ( su* c]tification & has a purpose o!r ?an to p>ticipate 9 ! program e/abli%$ "u ?is section2 7iv7 9 ! case ( a c]tifi$ =eign sell] t is a lic5s$ =eign ph>macy1 agrees to disp5se a qualify+ prescription drug to an individual 9 ! ,unit$ ,/ates only aft] receiv+ a valid prescription1 z describ$ 9 p>agraph 7#b77;,c72 7v7 has processes e/abli%$ by ! sell]1 or p>ticipates 9 ano!r e/abli%$ process1 to c]tify t ! physical premises & data report+ proc$ures & lic5ses are 9 compliance ) all applicable laws & regulations ( ,canada1 or1 subject to subsection 7e71 ! p]mitt$ c\ntry 9 :i* ! sell] is locat$1 & has implem5t$ policies design$ to monitor ongo+ compliance ) su* laws & regulations2 7vi7 conducts or commits to p>ticipate 9 ongo+ & compreh5sive quality assurance programs & implem5ts su* quality assurance measures1 includ+ bl9d te/+1 to ensure ! v]acity & reliability ( ! f9d+s ( ! quality assurance program2 7vii7 agrees t1 pursuant to subsection 7g71 laboratories approv$ by ! ,secret>y may be au?oriz$ to conduct product te/+ to det]m9e ! *emical au!nticity ( sample ph>maceutical products2 7viii7 agrees to notify ! ,secret>y1 import]s1 & individuals ( product recalls 9 ,canada1 or pursuant to subsection 7e71 ! p]mitt$ c\ntry 9 :i* ! sell] is locat$1 & agrees to cease1 or refra9 f1 export+ su* product2 7ix7 has e/abli%$1 or w e/abli% or p>ticipate 91 a process = resolv+ grievances1 z def9$ by ! ,secret>y1 & w be held acc\ntable = violations ( e/abli%$ guidel9es & rules2 7x7 except z o!rwise p]mitt$ "u ?is section1 does n sell products t ! sell] c\ld n o!rwise legally sell 9 ,canada1 or1 subject to subsection 7e71 ! p]mitt$ c\ntry 9 :i* su* sell] is locat$ to cu/om]s 9 ! ,unit$ ,/ates2 & 7xi7 meets any o!r crit]ia e/abli%$ by ! ,secret>y4 7,c7 ,c]tification fee ,n lat] ?an #cj days be=e ! />t ( ea* fiscal ye>1 ! ,secret>y %all e/abli% a fee to be collect$ f =eign sell]s = su* fiscal ye> t are c]tifi$ "u subp>agraph 7,b71 9 an am\nt t is suffici5t1 & n m ?an necess>y1 to pay ! co/s ( adm9i/]+ ! program "u ?is section1 & en=c+ ?is section pursuant to section #cjc7;h71 = t fiscal ye>4 7,d7 ,rec]tification ,a c]tification "u subp>agraph 7,b7 %all be 9 effect = a p]iod ( #b ye>s1 or until !re is a mat]ial *ange 9 ! circum/ances "u :i* ! =eign sell] meets ! requirem5ts "u su* subp>agraph1 :i*ev] occurs e>li]4 ,a =eign sell] may reapply = c]tification "u su* subp>agraph 7,b71 9 accordance ) a process e/abli%$ by ! ,secret>y4 7#b7 ,individuals ,an individual may import a qualify+ prescription drug describ$ 9 subsection 7b7 f ,canada or ano!r c\ntry pursuant to subsection 7e7 if su* drug-- 7,a7 is disp5s$1 includ+ ?r\gh an onl9e ph>macy1 by a c]tifi$ =eign sell] t is a lic5s$ =eign ph>macy2 7,b7 is pur*as$ = p]sonal use by ! individual1 n = resale1 9 quantities t d n exce$ a #ij-;day supply2 & 7,c7 is fill$ only aft] provid+ to ! lic5s$ =eign ph>macy a valid prescription issu$ by a heal? c>e practition] lic5s$ to practice 9 a ,/ate 9 ! ,unit$ ,/ates4 7e7 ,importation f o!r c\ntries ,beg9n+ on ! date t is #b ye>s aft] ! date on :i* f9al regulations are promulgat$ to c>ry out ?is section1 if1 bas$ on a review ( ! evid5ce obta9$ aft] su* effective date1 includ+ ! reports submitt$ "u section #b7;d7 ( ! ,af=dable ,m$ications ,act1 t importation ( qualify+ prescription drugs f ,canada "u ?is section result$ 9 co/ sav+s = consum]s 9 ! ,unit$ ,/ates & increas$ access to safe m$ication1 ! ,secret>y %all h ! au?ority to p]mit importation ( qualify+ prescription drugs by import]s & individuals f1 9 addition to ,canada1 any c\ntry t-- 7#a7 is a memb] ( ! ,organisation = ,economic ,co-op]ation & ,developm5t2 & 7#b7 has /atutory or regulatory /&>ds = ! approval & sale ( prescription drugs t are comp>able to ! /&>ds 9 ! ,unit$ ,/ates & t-- 7,a7 au?orizes ! approval ( drugs only if a drug has be5 det]m9$ to be safe & effective by exp]ts employ$ by or act+ on behalf ( a gov]nm5tal entity & qualifi$ by sci5tific tra9+ & exp]i5ce to evaluate ! safety & effectiv5ess ( drugs2 7,b7 requires t any det]m9ation ( safety & effectiv5ess describ$ 9 subp>agraph 7,a7 be made on ! basis ( adequate & well-controll$ inve/igations1 includ+ cl9ical inve/igations1 z appropriate1 conduct$ by exp]ts qualifi$ by sci5tific tra9+ & exp]i5ce to evaluate ! safety & effectiv5ess ( drugs2 7,c7 requires ! me?ods us$ 91 & ! facilities & controls us$ =1 ! manufacture1 process+1 & pack+ ( drugs 9 ! c\ntry to be adequate to pres]ve ! id5tity1 quality1 purity1 & /r5g? ( ! drugs2 & 7,d7 requires ! report+ ( adv]se reactions to drugs & e/abli% proc$ures to recall1 & )draw approval (1 drugs f\nd n to be safe or effective4 7f7 ,label+ ,any qualify+ prescription drug import$ t meets ! label+ requirem5ts describ$ 9 subsection 7b77#e77;,a77iv7 is deem$ n misbr&$ = purposes ( section #ejb4 7g7 ,drug te/+ laboratories ,! ,secret>y may approve "o or m laboratories to conduct r&om te/+ ( prescription drugs sold by c]tifi$ =eign sell]s to assess ! *emical au!nticity ( su* drugs4 7h7 ,unfair & discrim9atory ,acts & practices ,x is unlawful = a manufactur]1 directly or indirectly 7includ+ by be+ a p>ty to a lic5s+ agreem5t or o!r agreem5t7-- 7#a7 to discrim9ate by *>g+ a high] price = a prescription drug sold to a c]tifi$ =eign sell] t sells su* drug to an import] 9 accordance ) ?is section ?an ! price t is *>g$1 inclusive ( rebates or o!r inc5tives to ! c\ntry f :i* ! drug is export$1 to ano!r p]son t is 9 ! same c\ntry & t does n import su* a drug into ! ,unit$ ,/ates 9 accordance ) ?is section2 7#b7 except ) respect to a prescription drug on ! drug %ortage li/ "u section #ejf;,e1 discrim9ate by d5y+1 re/rict+1 or delay+ supplies ( a prescription drug to a c]tifi$ =eign sell]1 on acc\nt ( su* sell]'s /atus z a c]tifi$ =eign sell]1 t sells su* drug to an import] 9 accordance ) ?is section1 or by publicly1 privately1 or o!rwise refus+ to d bus9ess ) su* a c]tifi$ =eign sell] on acc\nt ( su* sell]'s /atus z a c]tifi$ =eign sell]2 7#c7 cause !re to be a diff]5ce 7includ+ a diff]5ce 9 active +r$i5t1 r\te ( adm9i/ration1 bioequival5ce1 /r5g?1 =mulation1 manufactur+ e/abli%m5t1 manufactur+ process1 or p]son t manufactures ! drug7 betwe5 a prescription drug = di/ribution 9 ! ,unit$ ,/ates & ! drug = di/ribution 9 ,canada or ano!r p]mitt$ c\ntry1 subject to subsection 7e71 = ! purpose ( avoid+ sales by c]tifi$ =eign sell]s2 or 7#d7 except ) respect to a prescription drug on ! drug %ortage li/ "u section #ejf;,e1 engage 9 any o!r action to re/rict1 prohibit1 or delay ! importation ( a prescription drug "u ?is section4 7i7 ,in=mation & records 7#a7 ,biannual reports ,ea* import] %all submit biannual reports to ! ,secret>y :i* %all conta91 = ea* qualify+ prescription drug import$ into ! ,unit$ ,/ates-- 7,a7 ! unique facility id5tifi] ( ! manufactur] ( ! drug1 describ$ 9 section #eaj2 7,b7 ! transaction in=mation describ$ 9 section #eha7bf7 7o!r ?an ! in=mation describ$ 9 subp>agraph 7,c772 & 7,c7 ! price paid by ! import] = ! drug4 7#b7 ,ma9t5ance ( records by ,secret>y ,! ,secret>y %all ma9ta9 in=mation & docum5tation submitt$ "u p>agraph 7#a7 = su* p]iod ( "t z ! ,secret>y det]m9es to be appropriate4 7j7 ,susp5sion ( importation 7#a7 ,patt]ns ( noncompliance ,! ,secret>y %all require t importation ( a specific qualify+ prescription drug or importation by a specific c]tifi$ =eign sell] or import] pursuant to ?is section be imm$iately susp5d$ if ! ,secret>y det]m9es t !re is a patt]n ( importation ( su* specific drug or by su* specific sell] or import] t involves c\nt]feit drugs1 drugs t h be5 recall$ or )drawn1 or drugs 9 violation ( any requirem5t ( ?is section1 until an inve/igation is complet$ & ! ,secret>y det]m9es t importation ( su* drug or by su* sell] or import] does n endang] ! public heal?4 7#b7 ,tempor>y susp5sion ,! ,secret>y may require t importation ( a specific qualify+ prescription drug or importation by a specific c]tifi$ =eign sell] or import] pursuant to ?is section be tempor>ily susp5d$ if1 ) respect to su* drug1 sell]1 or import]1 !re is a violation ( any requirem5t ( ?is section or if ! ,secret>y det]m9es t importation ( su* drug or by su* sell] or import] might endang] ! public heal?4 ,su* tempor>y susp5sion %all apply until ! ,secret>y completes an inve/igation & det]m9es t importation ( su* drug or by su* sell] or import] does n endang] ! public heal?4 7k7 ,supply *a9 security 7#a7 ,pur*ase f regi/]$ facilities & c]tifi$ =eign sell]s 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b71 c]tifi$ =eign sell]s :o sell qualify+ prescription drugs = importation into ! ,unit$ ,/ates pursuant to ?is section may pur*ase su* drugs only f manufactur]s or entities regi/]$ "u section #eaj or o!r c]tifi$ =eign sell]s4 7,b7 ,exception ,c]tifi$ =eign sell]s :o sell qualify+ prescription drugs = importation into ! ,unit$ ,/ates pursuant to ?is section may pur*ase su* drugs f =eign sell]s 9 ,canada or ano!r p]mitt$ c\ntry1 ev5 if su* =eign sell] is n a manufactur] regi/]$ "u section #eaj or a c]tifi$ =eign sell]1 if ! ,secret>y ent]s into a memor&um ( und]/&+ or coop]ative agreem5t ) ,canada1 or su* o!r p]mitt$ c\ntry1 to ensure compliance1 to ! ext5t appropriate & feasible1 ) sub*apt] ,h ( *apt] ,v4 ,! ,secret>y %all seek to ent] into su* a memor&um ( und]/&+ or coop]ative agreem5t ) ,canada & ea* c\ntry f :i* importation is p]mitt$ "u subsection 7e74 7#b7 ,importation trac+ ,c]tifi$ =eign sell]s %all provide import]s ) ! unique facility id5tifi] associat$ ) ! manufactur] regi/]$ "u section #eaj ( ! qualify+ prescription drug & ! in=mation "u p>agraph 7#be71 p>agraph 7#bf7 7o!r ?an subp>agraph 7,c771 & subp>agraphs 7,d71 7,f71 & 7,g7 ( p>agraph 7#bg7 ( section #eha4 ,c]tifi$ =eign sell]s %all provide su* in=mation to individuals pur*as+ su* drugs1 ^u reque/4 7l7 ,r,e,ms ,9 ! case ( an import] t imports a qualify+ prescription drug1 :]e ! drug ) ! same active +r$i5t or +r$i5ts 7or t is biosimil> to an approv$ biological product71 r\te ( adm9i/ration1 & /r5g? t is approv$ "u *apt] ,v or section #cea ( ! ,public ,heal? ,s]vice ,act is subject to elem5ts to assure safe use "u section #eje-a1 su* import] %all be subject to su* elem5ts to assure safe use1 z applicable & appropriate4 7m7 ,con/ruction ,no?+ 9 ?is section limits ! au?ority ( ! ,secret>y relat+ to ! importation ( prescription drugs1 o!r ?an ) respect to section #hja7;d77#a7 z provid$ 9 ?is section4 4 7b7 ,p5alties ) respect to onl9e ph>macies ,section #cjc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 is am5d$ by add+ at ! end ! foll[+3 7h7 ,9 ! case ( a p]son op]at+ an int]net website1 :e!r 9 ! ,unit$ ,/ates or 9 ano!r c\ntry1 t violates section #cja7;aa7 by-- 7#a7 sell+1 by means ( ! int]net1 ) ! int5t to defraud or mislead or ) reckless disreg>d = safety ( ! public1 an adult]at$ or c\nt]feit drug to an individual 9 ! ,unit$ ,/ates2 or 7#b7 disp5ses1 by means ( ! int]net1 a drug to an individual 9 ! ,unit$ ,/ates :o ! p]son kn[s or has reasonable cause to believe1 does n possess a valid prescription = t drug1 su* p]son %all be imprison$ = n m ?an #aj ye>s or f9$ n m ?an #bej1jjj4 4 7c7 ,no preemption ,no?+ 9 ?is section1 includ+ ! am5dm5ts made by ?is section1 %all be con/ru$ to preempt1 alt]1 displace1 abridge1 or supplant any rem$y available "u any ,/ate or ,f$]al law1 includ+ common law1 t provides a rem$y = civil relief4 7d7 ,reports 7#a7 ,,hhs ,n lat] ?an #a ye> aft] ! date on :i* f9al regulations are promulgat$ to c>ry out section #hjd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #chd71 z am5d$ by subsection 7a71 & e #b ye>s !reaft]1 ! ,secret>y ( ,heal? & ,human ,s]vices1 aft] consultation ) appropriate ,f$]al ag5cies1 %all submit to ,congress & make public a report on ! importation ( drugs into ! ,unit$ ,/ates4 7#b7 ,,gao report ,n lat] ?an #ah mon?s aft] ! fir/ report is submitt$ "u p>agraph 7#a71 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report conta9+ an analysis ( ! implem5tation ( ! am5dm5ts made by ?is section1 includ+ a review ( drug safety & co/-sav+s & exp5ses1 includ+ co/-sav+s to consum]s 9 ! ,unit$ ,/ates & trans-%ipm5t & importation trac+ processes1 result+ f su* implem5tation4 #bjd4 ,requir+ drug manufactur]s to provide drug rebates = drugs disp5s$ to l[-income individuals 7a7 ,9 g5]al ,section #ahfj;,d-#b ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7 is am5d$-- 7#a7 9 subsection 7e77#a71 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ & subsection 7f7 aft] ?is subsection2 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7f7 ,prescription drug rebate agreem5t = rebate eligible individuals 7#a7 ,requirem5t 7,a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbj1 9 ?is "p1 ! t]m cov]$ "p ,d drug does n include any drug or biological product t is manufactur$ by a manufactur] t has n ent]$ into & h 9 effect a rebate agreem5t describ$ 9 p>agraph 7#b74 7,b7 #bjbj plan ye> requirem5t ,any drug or biological product manufactur$ by a manufactur] t decl9es to ent] into a rebate agreem5t describ$ 9 p>agraph 7#b7 = ! p]iod beg9n+ on ,janu>y #a1 #bjbj1 & end+ on ,decemb] #ca1 #bjbj1 %all n be includ$ z a cov]$ "p ,d drug = ! subsequ5t plan ye>4 7#b7 ,rebate agreem5t ,a rebate agreem5t "u ?is subsection %all require ! manufactur] to provide to ! ,secret>y a rebate = ea* rebate p]iod 7z def9$ 9 p>agraph 7#f77;,b77 end+ aft] ,decemb] #ca1 #bjai1 9 ! am\nt specifi$ 9 p>agraph 7#c7 = any cov]$ "p ,d drug ( ! manufactur] disp5s$ aft] ,decemb] #ca1 #bjai1 to any rebate eligible individual 7z def9$ 9 p>agraph 7#f77;,a77 = :i* paym5t 0 made by a ,,pdp sponsor or ,,ma organization "u ?is "p = su* p]iod1 includ+ paym5ts pass$ ?r\gh ! l[-income & re9surance subsidies "u sections #ahfj;,d-#ad & #ahfj;,d-#ae7;b71 respectively4 ,su* rebate %all be paid by ! manufactur] to ! ,secret>y n lat] ?an #cj days aft] ! date ( receipt ( ! in=mation describ$ 9 section #ahfj;,d-#ab7;b77#h71 includ+ z su* section is appli$ "u section #aheg7;f77#c71 or #cj days aft] ! receipt ( in=mation "u subp>agraph 7,d7 ( p>agraph 7#c71 z det]m9$ by ! ,secret>y4 ,ins(> z n inconsi/5t ) ?is subsection1 ! ,secret>y %all e/abli% t]ms & conditions ( su* agreem5t relat+ to compliance1 p5alties1 & program evaluations1 inve/igations1 & audits t are simil> to ! t]ms & conditions = rebate agreem5ts "u p>agraphs 7#c7 & 7#d7 ( section #aibg7;b74 7#c7 ,rebate = rebate eligible ,m$ic>e drug plan enrollees 7,a7 ,9 g5]al ,! am\nt ( ! rebate specifi$ "u ?is p>agraph = a manufactur] = a rebate p]iod1 ) respect to ea* dosage =m & /r5g? ( any cov]$ "p ,d drug provid$ by su* manufactur] & disp5s$ to a rebate eligible individual1 %all be equal to ! product (-- 7i7 ! total numb] ( units ( su* dosage =m & /r5g? ( ! drug s provid$ & disp5s$ = :i* paym5t 0 made by a ,,pdp sponsor or an ,,ma organization "u ?is "p = ! rebate p]iod1 includ+ paym5ts pass$ ?r\gh ! l[-income & re9surance subsidies "u sections #ahfj;,d-#ad & #ahfj;,d-#ae7;b71 respectively2 & 7ii7 ! am\nt 7if any7 by :i*-- 7,i7 ! ,m$icaid rebate am\nt 7z def9$ 9 subp>agraph 7,b77 = su* =m1 /r5g?1 & p]iod2 exce$s 7,,ii7 ! av]age ,m$ic>e drug program rebate eligible rebate am\nt 7z def9$ 9 subp>agraph 7,c77 = su* =m1 /r5g?1 & p]iod4 7,b7 ,m$icaid rebate am\nt ,= purposes ( ?is p>agraph1 ! t]m ,m$icaid rebate am\nt means1 ) respect to ea* dosage =m & /r5g? ( a cov]$ "p ,d drug provid$ by ! manufactur] = a rebate p]iod-- 7i7 9 ! case ( a s+le s\rce drug or an innovator multiple s\rce drug1 ! am\nt specifi$ 9 p>agraph 7#a77;,a77ii77,,ii7 or 7#b77;,c7 ( section #aibg7;c7 plus ! am\nt1 if any1 specifi$ 9 subp>agraph 7,a77ii7 ( p>agraph 7#b7 ( su* section1 = su* =m1 /r5g?1 & p]iod2 or 7ii7 9 ! case ( any o!r cov]$ outpati5t drug1 ! am\nt specifi$ 9 p>agraph 7#c77;,a77i7 ( su* section = su* =m1 /r5g?1 & p]iod4 7,c7 ,av]age ,m$ic>e drug program rebate eligible rebate am\nt ,= purposes ( ?is subsection1 ! t]m av]age ,m$ic>e drug program rebate eligible rebate am\nt means1 ) respect to ea* dosage =m & /r5g? ( a cov]$ "p ,d drug provid$ by a manufactur] = a rebate p]iod1 ! sum1 = all ,,pdp sponsors "u "p ,d & ,,ma organizations adm9i/]+ an ,,ma-,,pd plan "u "p ,c1 (-- 7i7 ! product1 = ea* su* sponsor or organization1 (-- 7,i7 ! sum ( all rebates1 disc\nts1 or o!r price concessions 7n tak+ into acc\nt any rebate provid$ "u p>agraph 7#b7 or any disc\nts "u ! program "u section #ahfj;,d-#ad;,a7 = su* dosage =m & /r5g? ( ! drug disp5s$1 calculat$ on a p]-unit basis1 b only to ! ext5t t any su* rebate1 disc\nt1 or o!r price concession applies equally to drugs disp5s$ to rebate eligible ,m$ic>e drug plan enrollees & drugs disp5s$ to ,,pdp & ,,ma-,,pd enrollees :o are n rebate eligible individuals2 & 7,,ii7 ! numb] ( ! units ( su* dosage & /r5g? ( ! drug disp5s$ dur+ ! rebate p]iod to rebate eligible individuals enroll$ 9 ! prescription drug plans adm9i/]$ by ! ,,pdp sponsor or ! ,,ma-,,pd plans adm9i/]$ by ! ,,ma organization2 divid$ by 7ii7 ! total numb] ( units ( su* dosage & /r5g? ( ! drug disp5s$ dur+ ! rebate p]iod to rebate eligible individuals enroll$ 9 all prescription drug plans adm9i/]$ by ,,pdp sponsors & all ,,ma-,,pd plans adm9i/]$ by ,,ma organizations4 7,d7 ,use ( e/imates ,! ,secret>y may e/abli% a me?odology = e/imat+ ! av]age ,m$ic>e drug program rebate eligible rebate am\nts = ea* rebate p]iod bas$ on bid & utilization in=mation "u ?is "p & may use ^! e/imates z ! basis = det]m9+ ! rebates "u ?is section4 ,if ! ,secret>y elects to e/imate ! av]age ,m$ic>e drug program rebate eligible rebate am\nts1 ! ,secret>y %all e/abli% a reconciliation process = adju/+ manufactur] rebate paym5ts n lat] ?an #c mon?s aft] ! date t manufactur]s receive ! in=mation collect$ "u section #ahfj;,d-#ab7;b77#h77;,b74 7#d7 ,l5g? ( agreem5t ,! provisions ( p>agraph 7#d7 ( section #aibg7;b7 7o!r ?an clauses 7iv7 & 7v7 ( subp>agraph 7,b77 %all apply to rebate agreem5ts "u ?is subsection 9 ! same mann] z su* p>agraph applies to a rebate agreem5t "u su* section4 7#e7 ,o!r t]ms & conditions ,! ,secret>y %all e/abli% o!r t]ms & conditions ( ! rebate agreem5t "u ?is subsection1 includ+ t]ms & conditions relat$ to compliance1 t are consi/5t ) ?is subsection4 7#f7 ,def9itions ,9 ?is subsection & section #ahfj;,d-#ab7;b77#h73 7,a7 ,rebate eligible individual ,! t]m rebate eligible individual means-- 7i7 a subsidy eligible individual 7z def9$ 9 section #ahfj;,d-#ad7;a77#c77;,a772 7ii7 a ,m$icaid b5efici>y treat$ z a subsidy eligible individual "u clause 7v7 ( section #ahfj;,d-#ad7;a77#c77;,b72 & 7iii7 any "p ,d eligible individual n describ$ 9 clause 7i7 or 7ii7 :o is det]m9$ = purposes ( ! ,/ate plan "u title ,,xix to be eligible = m$ical assi/ance "u clause 7i71 7iii71 or 7iv7 ( section #aijb7;a77#aj77;,e74 7,b7 ,rebate p]iod ,! t]m rebate p]iod has ! mean+ giv5 su* t]m 9 section #aibg7k77#h74 4 7b7 ,report+ requirem5t = ! det]m9ation & paym5t ( rebates by manufactur]s relat$ to rebate = rebate eligible ,m$ic>e drug plan enrollees 7#a7 ,requirem5ts = ,,pdp sponsors ,section #ahfj;,d-#ab7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#h7 ,report+ requirem5t = ! det]m9ation & paym5t ( rebates by manufactur]s relat$ to rebate = rebate eligible ,m$ic>e drug plan enrollees 7,a7 ,9 g5]al ,= purposes ( ! rebate "u section #ahfj;,d-#b7;f7 = contract ye>s beg9n+ on or aft] ,janu>y #a1 #bjbj1 ea* contract ent]$ into ) a ,,pdp sponsor "u ?is "p ) respect to a prescription drug plan %all require t ! sponsor comply ) subp>agraphs 7,b7 & 7,c74 7,b7 ,report =m & cont5ts ,n lat] ?an a date specifi$ by ! ,secret>y1 a ,,pdp sponsor ( a prescription drug plan "u ?is "p %all report to ea* manufactur]-- 7i7 in=mation 7by ,national ,drug ,code numb]7 on ! total numb] ( units ( ea* dosage1 =m1 & /r5g? ( ea* drug ( su* manufactur] disp5s$ to rebate eligible ,m$ic>e drug plan enrollees "u any prescription drug plan op]at$ by ! ,,pdp sponsor dur+ ! rebate p]iod2 7ii7 in=mation on ! price disc\nts1 price concessions1 & rebates = su* drugs = su* =m1 /r5g?1 & p]iod2 7iii7 in=mation on ! ext5t to :i* su* price disc\nts1 price concessions1 & rebates apply equally to rebate eligible ,m$ic>e drug plan enrollees & ,,pdp enrollees :o are n rebate eligible ,m$ic>e drug plan enrollees2 & 7iv7 any additional in=mation t ! ,secret>y det]m9es is necess>y to enable ! ,secret>y to calculate ! av]age ,m$ic>e drug program rebate eligible rebate am\nt 7z def9$ 9 p>agraph 7#c77;,c7 ( su* section71 & to det]m9e ! am\nt ( ! rebate requir$ "u ?is section1 = su* =m1 /r5g?1 & p]iod4 ,su* report %all be 9 a =m consi/5t ) a /&>d report+ =mat e/abli%$ by ! ,secret>y4 7,c7 ,submission to ,secret>y ,ea* ,,pdp sponsor %all promptly transmit a copy ( ! in=mation report$ "u subp>agraph 7,b7 to ! ,secret>y = ! purpose ( audit ov]sight & evaluation4 7,d7 ,confid5tiality ( in=mation ,! provisions ( subp>agraph 7,d7 ( section #aibg7;b77#c71 relat+ to confid5tiality ( in=mation1 %all apply to in=mation report$ by ,,pdp sponsors "u ?is p>agraph 9 ! same mann] t su* provisions apply to in=mation disclos$ by manufactur]s or :olesal]s "u su* section1 except-- 7i7 t any ref]5ce to ?is section 9 clause 7i7 ( su* subp>agraph %all be treat$ z be+ a ref]5ce to ?is section2 7ii7 ! ref]5ce to ! ,director ( ! ,congressional ,budget ,(fice 9 clause 7iii7 ( su* subp>agraph %all be treat$ z includ+ a ref]5ce to ! ,m$ic>e ,paym5t ,advisory ,commission2 & 7iii7 clause 7iv7 ( su* subp>agraph %all n apply4 7,e7 ,ov]sight ,in=mation report$ "u ?is p>agraph may be us$ by ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices = ! /atutorily au?oriz$ purposes ( audit1 inve/igation1 & evaluations4 7,f7 ,p5alties = failure to provide timely in=mation & provision ( false in=mation ,9 ! case ( a ,,pdp sponsor-- 7i7 t fails to provide in=mation requir$ "u subp>agraph 7,b7 on a timely basis1 ! sponsor is subject to a civil money p5alty 9 ! am\nt ( #aj1jjj = ea* day 9 :i* su* in=mation has n be5 provid$2 or 7ii7 t kn[+ly 7z def9$ 9 section #aabh;,a7i77 provides false in=mation "u su* subp>agraph1 ! sponsor is subject to a civil money p5alty 9 an am\nt n to exce$ #ajj1jjj = ea* item ( false in=mation4 ,su* civil money p5alties are 9 addition to o!r p5alties z may be prescrib$ by law4 ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil money p5alty "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 4 7#b7 ,application to ,,ma organizations ,section #aheg7;f77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;f77#c77 is am5d$ by add+ at ! end ! foll[+3 7,e7 ,report+ requirem5t relat$ to rebate = rebate eligible ,m$ic>e drug plan enrollees ,section #ahfj;,d-#ab7;b77#h74 4 7c7 ,deposit ( rebates into ,m$ic>e ,prescription ,drug ,acc\nt ,section #ahfj;,d-#af7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaf7;c77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#f7 ,rebate = rebate eligible ,m$ic>e drug plan enrollees ,am\nts paid "u a rebate agreem5t "u section #ahfj;,d-#b7;f7 %all be deposit$ into ! ,acc\nt4 4 7d7 ,exclusion f det]m9ation ( be/ price & av]age manufactur] price "u ,m$icaid 7#a7 ,exclusion f be/ price det]m9ation ,section #aibg7;c77#a77;,c77ii77,i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#a77;,c77ii77,i77 is am5d$ by ins]t+ & am\nts paid "u a rebate agreem5t "u section #ahfj;,d-#b7;f7 aft] ?is section4 7#b7 ,exclusion f av]age manufactur] price det]m9ation ,section #aibg7k77#a77;,b77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#a77;,b77i77 is am5d$-- 7,a7 9 subclause 7,,iv71 by /rik+ & aft] ! semicolon2 7,b7 9 subclause 7,v71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+3 7,,vi7 am\nts paid "u a rebate agreem5t "u section #ahfj;,d-#b7;f74 4 #bje4 ,cap on prescription drug co/-%>+ 7a7 ,qualifi$ heal? plans ,section #acjb7;c7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjbb7;c77 is am5d$-- 7#a7 9 p>agraph 7#c77;,a77i71 by ins]t+ 1 includ+ co/-%>+ ) respect to prescription drugs cov]$ by ! plan aft] *>ges2 & 7#b7 by add+ at ! end ! foll[+3 7#e7 ,prescription drug co/-%>+ 7,a7 #bjbj ,= plan ye>s beg9n+ 9 #bjbj1 ! co/-%>+ incurr$ "u a heal? plan ) respect to prescription drugs cov]$ by ! plan %all n exce$ #bej p] mon? = ea* enroll$ individual1 or #ejj = ea* family4 7,b7 #bjba & lat] 7i7 ,9 g5]al ,9 ! case ( any plan ye> beg9n+ 9 a cal5d> ye> aft] #bjbj1 ! limitation "u ?is p>agraph %all be equal to ! applicable doll> am\nt "u subp>agraph 7,a7 = plan ye>s beg9n+ 9 #bjbj1 increas$ by an am\nt equal to ! product ( t am\nt & ! m$ical c>e compon5t ( ! consum] price index = all urban consum]s 7z publi%$ by ! ,bureau ( ,labor ,/ati/ics7 = t ye>4 7ii7 ,adju/m5t to am\nt ,if ! am\nt ( any increase "u clause 7i7 is n a multiple ( #e1 su* increase %all be r\nd$ to ! next l[e/ multiple ( #e4 4 7b7 ,gr\p heal? plans ,section #bgjg7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#f7;b77 is am5d$-- 7#a7 by /rik+ annual2 & 7#b7 by /rik+ p>agraph 7#a7 ( section #acjb7;c7 & ins]t+ p>agraphs 7#a7 & 7#e7 ( section #acjb7;c7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act4 7c7 ,effective date ,! am5dm5ts made by subsections 7a7 & 7b7 %all take effect ) respect to plans beg9n+ aft] ,decemb] #ca1 #bjai4 #bjf4 ,modification ( trade negotiat+ objectives relat+ to intellectual prop]ty rights to ensure access to biological products ,section #ajb7;b77#e77;,c7 ( ! ,bip>tisan ,congressional ,trade ,priorities & ,acc\ntability ,act ( #bjae 7#ai ,u4,s4,c4 #dbja7;b77#e77;,c77 is am5d$ by /rik+ ! end p]iod & ins]t+ ! foll[+3 1 includ+ by ensur+ t trade agreem5ts d n require a p>ty to provide biological product exclusivity ( m ?an #g ye>s4 4 ,,iii ,innovation #cja4 ,innovation inc5tive fund = new & m effective treatm5ts ( bact]ial infections ,"p ,b ( title ,,iv ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhd et seq47 is am5d$ by add+ at ! end ! foll[+3 #dji,k4 ,innovation inc5tive fund = new & m effective treatm5ts ( bact]ial infections 7a7 ,e/abli%m5t ( fund ,!re is h]eby e/abli%$ 9 ! ,treasury ( ! ,unit$ ,/ates a revolv+ fund to be kn[n z ! ,antibiotics ,innovation ,inc5tive ,fund1 :i* %all consi/ ( funds transf]r$ "u subsection 7b74 7b7 ,am\nts cr$it$ to ! fund ,!re are h]eby au?oriz$ to be appropriat$1 & appropriat$1 to ! ,antibiotics ,innovation ,inc5tive ,fund1 = fiscal ye> #bjbj1 out ( any monies 9 ! ,treasury n o!rwise appropriat$1 #b1jjj1jjj1jjj4 ,su* funds %all rema9 available until exp5d$4 7c7 ,aw>ds 7#a7 ,9 g5]al ,dur+ ! #aj-ye> p]iod foll[+ ! date ( enactm5t ( ! ,af=dable ,m$ications ,act1 ! ,director ( ! ,,nih1 9 accordance ) ! crit]ia "u subsection 7d7 & ! goals "u subsection 7e71 %all aw>d-- 7,a7 up to #c m>ket entry aw>ds = qualify+ products t provide add$ b5efit = pati5ts ov] exi/+ !rapies 9 ! treatm5t ( s]i\s & life-?reat5+ bact]ial infections demon/rat+ 9 sup]iority trials2 & 7,b7 aw>d op5 s\rce divid5d prizes = contributions t significantly advance ! field ( antibiotic rese>* ) op5ly s\rc$ mat]ials1 te*nology1 data1 & k4 7#b7 ,aw>d am\nt requirem5ts ,no m ?an #e p]c5t ( ! am\nt available 9 ! ,antibiotics ,innovation ,inc5tive %all be d$icat$ to op5 s\rce divid5d prizes4 7d7 ,crit]ia & /ructure ( prizes 7#a7 ,e/abli%m5t ( crit]ia ,n lat] ?an #abj days aft] ! date ( enactm5t ( ! ,af=dable ,m$ications ,act1 ! ,director ( ,,nih %all e/abli% crit]ia = ! selection ( recipi5ts & eligibility ( p]sons = m>ket entry rew>ds & op5 s\rce divid5d prizes "u ?is section & crit]ia = det]m9+ ! am\nts ( su* prizes1 ?r\gh notice & comm5t rulemak+4 7#b7 ,consid]ations 9 e/abli%+ crit]ia = qualify+ products ,9 e/abli%+ ! crit]ia = selection ( recipi5ts & am\nts ( m>ket entry rew>ds & op5 s\rce divid5d prizes "u p>agraph 7#a71 ! ,director ( ,,nih1 9 consultation ) o!r ag5cies z appropriate1 %all consid] ! foll[+3 7,a7 ,! numb] ( pati5ts 9 ! ,unit$ ,/ates & 9 o!r c\ntries :o w\ld b5efit f ! qualify+ product t treats a s]i\s or life-?reat5+ bact]ial infection1 & ! numb] ( pati5ts 9 ! ,unit$ ,/ates & 9 o!r c\ntries project$ to b5efit dur+ ! upcom+ #aj-ye> p]iod4 7,b7 ,:e!r ! qualify+ product treats1 or has ! pot5tial to treat1 a s]i\s or life-?reat5+ bact]ial infection = :i* no o!r treatm5t is curr5tly available or = :i* !re is a high ?reat ( resi/ance to exi/+ treatm5ts4 7,c7 ,! increm5tal & additional !rapeutic b5efit to human 9 ! ,unit$ ,/ates & o!r c\ntries ( ! qualify+ product z comp>$ to o!r treatm5ts available to treat ! bact]ial infection1 evaluat+ ! increm5tal !rapeutic b5efit 9 comp>ison to treatm5ts t 7 n rec5tly develop$4 7,d7 ,! transmissibility ( ! bact]ial infection ! qualify+ product w\ld treat1 & b>ri]s to prev5tion ( t infection4 7,e7 ,! ext5t to :i* k1 data1 mat]ials1 & te*nology t are op5ly s\rc$ h contribut$ to ! successful developm5t ( new treatm5ts t provide an add$ b5efit to pati5ts1 su* z decreas+ mortality or irrev]sible morbidity on pati5t-c5t]$ outcomes1 significantly advanc+ ! field ( antibiotic rese>*1 or improv+ processes = manufactur+ products us$ = ! treatm5t4 7,f7 ,o!r crit]ia t ! ,director ( ,,nih det]m9es to be relevant & useful 9 ensur+ t ! prizes provide appropriate inc5tives4 7#c7 ,crit]ia = op5 s\rce divid5d prizes ,an op5 s\rce divid5d prize "u ?is section %all rew>d p]sons t op5ly %>$ on a royalty-free1 n-=-pr(it & non-discrim9atory basis1 mat]ials1 te*nology1 data1 & k t contribute 9 a significant way to ! successful developm5t ( a qualify+ product or significantly advanc$ ! field ( antibiotic rese>*4 7e7 ,goals ,) respect to ea* ye> = :i* ! ,director ( ,,nih aw>ds m>ket entry rew>ds & op5 s\rce divid5d prizes "u subsection 7c71 ! ,director ( ,,nih %all e/abli% a framework ( goals t a qualify+ product or contribution t significantly advances ! field ( antibiotic rese>* is requir$ to %[ promise to help meet 9 ord] = a p]son to be eligible to receive a m>ket entry rew>d or op5 s\rce divid5d prize ) respect to su* product or su* contribution4 ,su* goals may include-- 7#a7 r$uc$ hospital admissions or readmissions2 7#b7 use ( diagno/ics prior to prescrib+ ( drugs2 & 7#c7 use ( innovative programs = antibiotic /ew>d%ip4 7f7 ,condition on receipt ( m>ket entry rew>d 7#a7 ,9 g5]al ,ea* m>ket entry rew>d = a qualify+ product (f]$ "u ?is section %all be condition$ on ! foll[+3 7,a7 ,! recipi5t %all agree to (f] ! qualify+ product at a reasonable price z describ$ 9 p>agraph 7#c74 7,b7 ,subject to applicable pati5t privacy protections1 ! recipi5t %all agree to publicly disclose all pre-cl9ical & cl9ical trial data ) respect to ! qualify+ product4 7,c7 ,! recipi5t %all agree to submit to ! ,director ( ,,nih1 = review & approval by su* director1 9 collaboration ) ! ,commission] ( ,food & ,drugs & ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 all m>ket+1 sales1 & o!r promotional & educational activities associat$ ) ! qualify+ product1 to ensure t su* activities align )1 & advance ! goals (1 res\rce cons]v+ /ew>d%ip1 protect+ ! utility ( antibiotics1 & enc\rag+ & ensur+ ! correct use ( antibiotics4 7,d7 ,! recipi5t %all irrevocably waive-- 7i7 all p]iods ( exclusivity available to ! product "u *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea ( ?is ,act2 & 7ii7 all applicable pat5t rights "u title #ce1 ,unit$ ,/ates ,code4 7,e7 ,any o!r conditions ! ,director ( ,,nih det]m9es appropriate4 7#b7 ,applicability ,all conditions describ$ 9 p>agraph 7#a7 %all apply to subsequ5t own]s1 lic5sees1 produc]s1 & manufactur]s1 & assignees ( ! product or any *emical compon5t ( ! qualify+ product = :i* ! m>ket entry rew>d 0 aw>d$4 7#c7 ,reasonable price 7,a7 ,9 g5]al ,a recipi5t may satisfy ! requirem5t to (f] a qualify+ product or contribution at a reasonable price = purposes ( p>agraph 7#a77;,a7 by-- 7i7 7,i7 provid+ op5 lic5s+ ( all necess>y rights to pat5ts1 manufactur+ processes1 rights 9 data1 & o!r intellectual prop]ty rights ne$$ to make & sell ! product to manufactur]s ( ! g5]ic v]sion ( su* product2 or 7,,ii7 sell+ su* product at a price t is no m ?an twice ! price ( antibiotic drugs approv$ "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act ) simil> manufactur+ co/s2 & 7ii7 sell+ su* product at a price t is n high] ?an ! m$ian price *>g$1 at ! "t ( su* sale1 9 ! applicable #g c\ntries1 z det]m9$ "u 9 subp>agraph 7,b74 7,b7 ,crit]ia ,= purposes ( subp>agraph 7,a77ii71 ! ,director ( ,,nih %all id5tify1 on an annual basis1 ! c\ntries t h a p] capita income t is n less ?an half ! p] capita income ( ! ,unit$ ,/ates1 select ! #g ( su* c\ntries t h ! l>ge/ gross dome/ic product1 & det]m9e ! m$ian price *>g$ = ea* qualify+ product = :i* an aw>d has be5 grant$ "u subsection 7c74 7g7 ,en=cem5t ,if ! m>ket entry rew>d recipi5t1 or subsequ5t own]1 lic5see1 or assignee ( ! qualify+ product1 does n fulfill ! conditions describ$ subsection 7f77#a71 ! ,secret>y1 9 collaboration ) ! ,attorney ,g5]al1 %all take all necess>y action to clawback ! m>ket entry rew>d4 7h7 ,transp>5cy ,) respect to ea* m>ket entry rew>d or op5 s\rce divid5d prize aw>d$ "u ?is section1 ! ,director ( ,,nih %all make public-- 7#a7 ! me?odology us$ & crit]ia analyz$ 9 det]m9+ ! m>ket entry rew>d or op5 s\rce divid5d prize recipi5t2 & 7#b7 a complete analysis ( ! recipi5t's fulfillm5t ( aw>d conditions "u subsection 7e77#a74 7i7 ,qualify+ product ,= purposes ( ?is section1 ! t]m qualify+ product means a drug 7z def9$ 9 section #bja7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act7 subject to section #ejc7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 7j7 ,/udy 7#a7 ,9 g5]al ,! ,director ( ,,nih %all seek to ent] into an agreem5t ) ! ,national ,academies ( ,sci5ces1 ,eng9e]+1 & ,m$ic9e to conduct a /udy to exam9e-- 7,a7 ! use ( innovation inducem5t rew>d funds & pu% f9anc+ me*anisms z ways to /imulate inve/m5ts 9 biom$ical rese>* & developm5t t de-l9ks co/s f product prices2 7,b7 models ( diff]5t possible means ( de-l9k+ rese>* & developm5t co/s f drug prices1 includ+ ! progressive replacem5t ( ! monopoly on new products ) a comb9ation ( exp&$ rese>* subsidies & new inc5tives f innovation inducem5t funds to /imulate ! developm5t ( drugs1 includ+ drugs to treat bact]ial infections1 r>e diseases1 ,,hiv_/,,aids1 & canc]2 7,c7 ! size ( m>ket entry rew>ds1 op5 s\rce divid5ds & o!r innovation inducem5t prizes t w\ld be necess>y to a*ieve innovation objectives & ! relative co/ effectiv5ess ( inc5tives del9k$ f ! prices ( products & s]vices 9 /imulat+ innovation1 comp>$ to "t-limit$ monopolies2 & 7,d7 me?ods ( progressively implem5t+ policies t del9k rese>* & developm5t fund+ f prices ( products & s]vices1 includ+ to ! progressive r$uction 9 ! effective t]m ( exclusive rights1 accompani$ by a progressive introduction & expansion ( m>ket entry rew>ds4 7#b7 ,au?orization ( appropriations ,= ! purpose ( c>ry+ out ?is subsection1 !re are au?oriz$ to be appropriat$1 & !re are appropriat$1 #c1jjj1jjj = fiscal ye> #bjbj4 ,su* funds %all rema9 available until exp5d$4 4 #cjb4 ,public fund+ = cl9ical trials 7a7 ,9 g5]al ,"p ,e ( title ,,iv ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhg et seq47 is am5d$ by add+ at ! end ! foll[+3 #f ,c5t] = ,cl9ical ,rese>* #dhe;,e4 ,c5t] = ,cl9ical ,rese>* 7a7 ,9 g5]al ,!re is e/abli%$ )9 ! ,national ,in/itutes ( ,heal? ! ,c5t] = ,cl9ical ,rese>*1 = ! purpose ( conduct+ cl9ical trials on drugs1 z describ$ 9 subsection 7b71 ) ! int5tion ( obta9+ approval ( su* drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea ( ?is ,act4 ,! ,director ( ,,nih %all appo9t a ,director ( ! ,c5t] = ,cl9ical ,rese>* ref]r$ to 9 ?is section z ! ,director7 n lat] ?an #ij days aft] ! date ( enactm5t ( ! ,af=dable ,m$ications ,act4 7b7 ,cl9ical trials 7#a7 ,9 g5]al ,ea* ye>1 beg9n+ n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,af=dable ,m$ications ,act1 ! ,director %all select at lea/ #b molecules1 comp\nds1 drugs1 or biological products & conduct cl9ical trials on su* molecules1 comp\nds1 drugs1 or biological products1 or ent] into contracts ) o!r entities to conduct su* cl9ical trials4 7#b7 ,selection ( drugs 7,a7 ,crit]ia ,! ,director %all e/abli% crit]ia1 :i* %all be made public1 = acquir+ ! pat5t rights =1 & select+1 drugs "u p>agraph 7#a7 to ensure t ! drugs select$ = cl9ical trials ?r\gh ! ,c5t]-- 7i7 h ! pot5tial to address an exi/+ or em]g+ ne$1 includ+ drugs t c be repurpos$ to treat a new condition 9 ! case ( a national em]g5cy2 & 7ii7 are n solely drugs t private sector rese>*]s ) access to all available in=mation on su* drugs *ose n to develop4 7,b7 ,process ,! ,director %all secure all pat5t rights to ea* drug select$ "u p>agraph 7#a71 z applicable1 & p]=m ! cl9ical trials at ,,nih or subcontract ) ano!r entity to conduct ! cl9ical trials4 7c7 ,treatm5t ( approv$ drugs ,if a drug = :i* cl9ical trials h be5 conduct$ by ! ,c5t] = ,cl9ical ,rese>* is approv$ by ! ,food & ,drug ,adm9i/ration "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea ( ?is ,act1 ! ,director %all-- 7#a7 execute non-exclusive lic5ses to all[ drug manufactur]s to manufacture & sell ! drug2 or 7#b7 9 collaboration ) o!r ,f$]al ag5cies z appropriate1 ent] into pur*as+ contracts4 7d7 ,public in=mation 7#a7 ,rese>* data & f9d+s ,subject to applicable pati5t privacy protections1 ! ,secret>y %all-- 7,a7 7i7 submit all complet$ /udies 7& t]m9at$ /udies1 if t]m9at$ = safety or e?ical reasons7 = publication 9 a pe]-review$ publication )9 #ahj days ( completion or t]m9ation2 & 7ii7 if a /udy submitt$ z describ$ 9 clause 7i7 is n select$ = publication1 publicly disclose all de-id5tifi$ prim>y cl9ical data n lat] ?an #ahj days aft] ! ,secret>y's f9al decision n to pursue fur!r submissions = publication2 & 7,b7 publicly disclose all de-id5tifi$ prim>y cl9ical data ^u publication ( a /udy z describ$ 9 subp>agraph 7,a77i74 7#b7 ,f9ancial in=mation ,! ,director %all make public all co/s to ! ,f$]al ,gov]nm5t associat$ ) c>ry+ out cl9ical trials by ! ,c5t] = ,cl9ical ,rese>* & ) subcontract agreem5ts "u ?is section1 9 a mann] t id5tifies ! co/ associat$ ) ea* trial4 7e7 ,def9ition ,9 ?is section1 ! t]m drug has ! mean+ giv5 su* t]m 9 section #bja7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 7f7 ,appropriations ,= ! purpose ( c>ry+ out ?is section1 9 addition to any o!r funds available = su* purpose1 !re are au?oriz$ to be appropriat$1 & !re are appropriat$1 #a1jjj1jjj1jjj = ea* ( fiscal ye>s #bjbj ?r\gh #bjcj1 to rema9 available until exp5d$4 4 7b7 ,cl]ical am5dm5t ,section #dja7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bha7;b77 is am5d$-- 7#a7 by r$esignat+ p>agraph 7#be7 z p>agraph 7#bf72 & 7#b7 by ins]t+ aft] p>agraph 7#bd7 ! foll[+3 7#be7 ,! ,c5t] = ,cl9ical ,rese>*4 4 #cjc4 ,rew>d+ innovative drug developm5t 7a7 ,drug exclusivity 7#a7 ,new *emical entity exclusivity 7,a7 ,9 g5]al ,section #eje7;j77#e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77 is am5d$-- 7i7 9 subp>agraph 7,b7-- 7,i7 9 clause 7i71 by ins]t+ except t su* approval may n be made effective be=e ! date t is #e ye>s aft] ! date on :i* ! drug to :i* ! application ref]s 0 approv$ "u subsection 7c7 be=e ! p]iod2 & 7,,ii7 9 clause 7ii71 by ins]t+ except t su* approval may n be made effective be=e ! date t is #e ye>s aft] ! date on :i* ! drug to :i* ! application ref]s 0 approv$ "u subsection 7c7 be=e ! p]iod2 & 7ii7 9 subp>agraph 7,f77ii7-- 7,i7 by /rik+ expiration ( five ye>s & ins]t+ expiration ( #c ye>s2 7,,ii7 by /rik+ 1 except t su* an application may be submitt$ "u ?is subsection aft] ! expiration ( f\r ye>s f ! date ( ! approval ( ! subsection 7b7 application if x conta9s a c]tification ( pat5t invalidity or non9fr+em5t describ$ 9 subclause 7,,iv7 ( p>agraph 7#b77;,a77vii72 & 7,,iii7 by /rik+ sev5 & "o-half ye>s & ins]t+ #f & "o-half ye>s4 7,b7 ,con=m+ am5dm5ts ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$-- 7i7 9 subsection 7v77#b77;,a77i77,,ii7 ( section #eje1 by ins]t+ ! #c-ye> exclusivity p]iod ref]r$ to be=e "u clause 7ii7 ( subsection 7j77#e77;,f72 7ii7 9 subsections 7b77#a77;,a77i77,i7 & 7c77#a77;,a77i77,i7 ( section #eje;,a-- 7,i7 by /rik+ five ye>s ea* place su* t]m appe>s & ins]t+ #c ye>s2 7,,ii7 by /rik+ sev5 & "o-half ye>s ea* place su* t]m appe>s & ins]t+ #f & "o-half ye>s2 & 7,,iii7 by /rik+ eight ye>s ea* place su* t]m appe>s & ins]t+ #g ye>s2 & 7iii7 9 section #eje;,e1 by /rik+ ! #d- & #e-ye> p]iods describ$ 9 subsections 7c77#c77;,e77ii7 & 7j77#e77;,f77ii7 ( section #eje1 ! #c-ye> p]iods describ$ 9 clauses 7iii7 & 7iv7 ( subsection 7c77#c77;,e7 & clauses 7iii7 & 7iv7 ( subsection 7j77#e77;,f7 & ins]t+ ! #d- & #e-ye> p]iods describ$ 9 subsection 7c77#c77;,e77ii7 ( section #eje1 ! #c-ye> p]iods describ$ 9 clauses 7iii7 & 7iv7 ( subsection 7c77#c77;,e7 & clauses 7ii71 7iii71 & 7iv7 ( subsection 7j77#e77;,f74 7#b7 ,new cl9ical inve/igation exclusivity ,section #eje7;c77#c77;,e77iv7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77#c77;,e77iv77 is am5d$ by ins]t+ 1 & ! supplem5t %[s a significant cl9ical b5efit ov] exi/+ !rapies manufactur$ by ! applicant 9 ! #e-ye> p]iod prec$+ ! submission ( ! application1 be=e ! ,secret>y4 7#c7 ,biological product exclusivity 7,a7 ,9 g5]al ,section #cea7k77#g77;,a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77#g77;,a77 is am5d$ by /rik+ #ab ye>s & ins]t+ #g ye>s4 7,b7 ,con=m+ am5dm5ts ,p>agraphs 7#b77;,a7 & 7#c77;,a7 ( section #cea7m7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7m77 is am5d$ by /rik+ #ab ye>s ea* place x appe>s & ins]t+ #g ye>s4 7b7 ,applicability ,! am5dm5ts made by subsection 7a7 apply only ) respect to a drug or biological product = :i* ! li/$ drug 7z describ$ 9 section #eje7;j77#g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g777 or ref]5ce product 7z su* t]m is us$ 9 section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb77 is approv$ "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act1 z applicable1 on or aft] ! date ( enactm5t ( ?is ,act4 7c7 ,,gao /udy ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy & submit to ,congress a report t includes-- 7#a7 7,a7 ! numb] ( reque/s = designation z a drug = a r>e disease or condition "u section #ebf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb7 ! ,food & ,drug ,adm9i/ration receives ea* ye> 9 ! previ\s #aj-ye> p]iod2 7,b7 ! numb] ( su* reque/s grant$1 d5i$1 & p5d+2 7,c7 ! names ( all drugs receiv+ su* designation dur+ su* p]iod1 includ+ ! date ( approval & indication = :i* m>ket exclusivity 0 grant$2 & 7,d7 any drugs = :i* su* designation has be5 revok$ or am5d$ dur+ su* p]iod2 7#b7 = ea* drug s designat$ z a drug = a r>e disease or condition 9 ! previ\s #aj-ye> p]iod1 ! total annual exp5ditures = su* drugs "u ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 & ! ,m$icaid program "u title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq471 ! numb] ( ,m$ic>e & ,m$icaid b5efici>ies :o us$ ea* su* drug ea* ye> dur+ su* "t p]iod1 & any *anges 9 price p] unit dur+ su* "t p]iod2 & 7#c7 = a sample ( drugs 7select$ by ! ,comptroll] ,g5]al7 s designat$ 9 ! previ\s #aj-ye> p]iod1 to ! ext5t feasible-- 7,a7 gross rev5ues ( ! manufactur]s ) respect to ea* su* drug1 & manufactur] sp5d+ = m>ket+ & pati5t assi/ance programs2 7,b7 ! av]age price p] drug & h[ ^? prices *ang$ ov] "t = ! select$ drugs bas$ on indu/ry drug pric+ b5*m>ks2 & 7,c7 ! indications t 7 ! basis ( su* designation & o!r approv$ indications = ! drugs1 & ! indications = :i* ea* drug has mo/ commonly be5 us$1 includ+ non-approv$ indications = :i* ! drug may be recomm5d$ by ext]nal organizations su* z physician or pati5t organizations4 #cjd4 ,improv+ program integrity 7a7 ,9 g5]al ,sub*apt] ,e ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb et seq47 is am5d$ by add+ at ! end ! foll[+3 #efi;,e4 ,conditions on aw>d ( drug exclusivity 7a7 ,t]m9ation ( exclusivity ,not)/&+ any o!r provision ( ?is ,act1 any p]iod ( exclusivity describ$ 9 subsection 7b7 grant$ to a p]son or assign$ to a p]son on or aft] ! date ( enactm5t ( ?is section ) respect to a drug %all be t]m9at$ if ! p]son to :i* su* exclusivity 0 grant$ or any p]son to :i* su* exclusivity is assign$ commits a violation describ$ 9 subsection 7c77#a7 ) respect to su* drug4 7b7 ,exclusivities affect$ ,! p]iods ( exclusivity describ$ 9 ?is subsection are ^? p]iods ( exclusivity grant$ "u any ( ! foll[+ sections3 7#a7 ,clause 7ii71 7iii71 or 7iv7 ( section #eje7;c77#c77;,e74 7#b7 ,clause 7iv7 ( section #eje7;j77#e77;,b74 7#c7 ,clause 7ii71 7iii71 or 7iv7 ( section #eje7;j77#e77;,f74 7#d7 ,section #eje;,a4 7#e7 ,section #eje;,e4 7#f7 ,section #ebg4 7#g7 ,section #cea7k77#g7 ( ! ,public ,heal? ,s]vice ,act4 7#h7 ,any o!r provision ( ?is ,act t provides = m>ket exclusivity 7or ext5sion ( m>ket exclusivity7 ) respect to a drug4 7c7 ,violations 7#a7 ,9 g5]al ,a violation describ$ 9 ?is subsection is a violation ( a law describ$ 9 p>agraph 7#b71 en=c$ by a ,f$]al or ,/ate gov]nm5tal entity t results 9-- 7,a7 a crim9al conviction ( a p]son describ$ 9 subsection 7a72 7,b7 a civil judgm5t aga9/ a p]son describ$ 9 subsection 7a72 or 7,c7 a settlem5t agreem5t 9 :i* a p]son describ$ 9 subsection 7a7 admits to fault4 7#b7 ,laws describ$ ,! laws describ$ 9 ?is p>agraph are ! foll[+3 7,a7 ,! provisions ( ?is ,act t prohibit-- 7i7 ! adult]ation or misbr&+ ( a drug2 7ii7 ! mak+ ( false /atem5ts to ! ,secret>y or committ+ fraud2 or 7iii7 ! illegal m>ket+ ( a drug4 7,b7 ,section #cgbi ( title #ca1 ,unit$ ,/ates ,code4 7,c7 ,section #bhf or #bhg ( title #ah1 ,unit$ ,/ates ,code4 7,d7 ,! ,m$ic>e & ,m$icaid ,pati5t ,protection & ,program ,act ( #aihg 7commonly kn[n z ! ,antikickback ,/atute74 7,e7 ,section #aibg ( ! ,social ,security ,act4 7,f7 ,a ,/ate law aga9/ fraud comp>able to a law describ$ 9 subp>agraphs 7,a7 ?r\gh 7,e74 7d7 ,date ( exclusivity t]m9ation ,! date on :i* ! exclusivity %all be t]m9at$ z describ$ 9 subsection 7a7 is ! date on :i*1 z applicable-- 7#a7 a f9al judgm5t is ent]$ relat+ to a violation describ$ 9 subp>agraph 7,a7 or 7,b7 ( subsection 7c77#a72 or 7#b7 7,a7 a settlem5t agreem5t describ$ 9 subsection 7c77#a77;,c7 is approv$ by a c\rt ord] t is or becomes f9al & nonappealable2 or 7,b7 if !re is no c\rt ord] approv+ a settlem5t agreem5t describ$ 9 subsection 7c77#a77;,c71 a c\rt ord] dismiss+ ! applicable case1 issu$ aft] ! settlem5t agreem5t1 is or becomes f9al & nonappealable4 7e7 ,report+ ( in=mation 7#a7 ,9 g5]al ,a p]son describ$ 9 subsection 7a7 t commits a violation describ$ 9 subsection 7c77#a7 %all report su* violation to ! ,secret>y no lat] ?an #cj days aft] ! date t-- 7,a7 a f9al judgm5t is ent]$ relat+ to a violation describ$ 9 subp>agraph 7,a7 or 7,b7 ( subsection 7c77#a72 or 7,b7 7i7 a settlem5t agreem5t describ$ 9 subsection 7c77#a77;,c7 is approv$ by a c\rt ord] t is or becomes f9al & nonappealable2 or 7ii7 if !re is no c\rt ord] approv+ a settlem5t agreem5t describ$ 9 subsection 7c77#a77;,c71 a c\rt ord] dismiss+ ! applicable case1 issu$ aft] ! settlem5t agreem5t1 is or becomes f9al & nonappealable4 7#b7 ,civil p5alty ,a p]son :o fails to report a violation z requir$ "u p>agraph 7#a7 %all be subject to a civil p5alty 9 ! am\nt ( #bjj1jjj = ea* day ! failure to report cont9ues1 beg9n+ ) ! day aft] ! date on :i* su* report is due z describ$ 9 p>agraph 7#a74 4 7b7 ,,ftc ,!re are au?oriz$ to be appropriat$ to ! ,f$]al ,trade ,commission su* sums z may be necess>y = ! purpose ( c>ry+ out activities relat$ to address+ crim9al activity & anticompetitive practices by ph>maceutical companies4 ,,iv ,*oice & ,competition #dja4 ,unlawful comp5sation = delay 7a7 ,9 g5]al ,! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #dd et seq47 is am5d$ by ins]t+ aft] section #bf 7#ae ,u4,s4,c4 #eg;c-#b7 ! foll[+3 #bg4 ,pres]v+ access to af=dable g5]ics & biosimil>s 7a7 ,9 g5]al 7#a7 ,en=cem5t proce$+ ,! ,commission may initiate a proce$+ to en=ce ! provisions ( ?is section aga9/ ! p>ties to any agreem5t resolv+ or settl+1 on a f9al or int]im basis1 a pat5t infr+em5t claim1 9 connection ) ! sale ( a drug product or biological product4 7#b7 ,presumption & violation 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 9 su* a proce$+1 an agreem5t %all be presum$ to h anticompetitive effects & %all be a violation ( ?is section if-- 7i7 an ,,&a fil] or a biosimil> biological product application fil] receives any?+ ( value1 includ+ an exclusive lic5se2 & 7ii7 ! ,,&a fil] or biosimil> biological product application fil] agrees to limit or =ego rese>*1 developm5t1 manufactur+1 m>ket+1 or sales ( ! ,,&a product or biosimil> biological product1 z applicable1 = any p]iod ( "t4 7,b7 ,exception ,subp>agraph 7,a7 %all n apply if ! p>ties to su* agreem5t demon/rate by cle> & conv9c+ evid5ce t-- 7i7 ! value describ$ 9 subp>agraph 7,a77i7 is comp5sation solely = o!r goods or s]vices t ! ,,&a fil] or biosimil> biological product application fil] has promis$ to provide2 or 7ii7 ! procompetitive b5efits ( ! agreem5t outweigh ! anticompetitive effects ( ! agreem5t4 7b7 ,limitations ,9 det]m9+ :e!r ! settl+ p>ties h met _! burd5 "u subsection 7a77#b77;,b71 ! fact f9d] %all n presume-- 7#a7 t entry w\ld n h occurr$ until ! expiration ( ! relevant pat5t or /atutory exclusivity2 or 7#b7 t ! agreem5t's provision = entry ( ! ,,&a product or biosimil> biological product prior to ! expiration ( ! relevant pat5t or /atutory exclusivity means t ! agreem5t is procompetitive4 7c7 ,exclusions ,no?+ 9 ?is section %all prohibit a resolution or settlem5t ( a pat5t infr+em5t claim 9 :i* ! consid]ation grant$ by ! ,,nda hold] or biological product lic5se hold] to ! ,,&a fil] or biosimil> biological product application fil]1 respectively1 z "p ( ! resolution or settlem5t includes only "o or m ( ! foll[+3 7#a7 ,! "r to m>ket ! ,,&a product or biosimil> biological product 9 ! ,unit$ ,/ates prior to ! expiration (-- 7,a7 any pat5t t is ! basis = ! pat5t infr+em5t claim2 or 7,b7 any pat5t "r or o!r /atutory exclusivity t w\ld prev5t ! m>ket+ ( su* ,,&a product or biosimil> biological product4 7#b7 ,a paym5t = reasonable litigation exp5ses n to exce$ #g1ejj1jjj4 7#c7 ,a cov5ant n to sue on any claim t ! ,,&a product or biosimil> biological product infr+es a ,unit$ ,/ates pat5t4 7d7 ,en=cem5t 7#a7 ,en=cem5t ,a violation ( ?is section %all be treat$ z a violation ( section #e4 7#b7 ,judicial review 7,a7 ,9 g5]al ,any p>ty t is subject to a f9al ord] ( ! ,commission1 issu$ 9 an adm9i/rative adjudicative proce$+ "u ! au?ority ( subsection 7a77#a71 may1 )9 #cj days ( ! issuance ( su* ord]1 petition = review ( su* ord] 9-- 7i7 ! ,unit$ ,/ates ,c\rt ( ,appeals = ! ,di/rict ( ,columbia ,circuit2 7ii7 ! ,unit$ ,/ates ,c\rt ( ,appeals = ! circuit 9 :i* ! ultimate p>5t entity1 z def9$ 9 section #hja4a7;a77#c7 ( title #af1 ,code ( ,f$]al ,regulations1 or any successor !reto1 ( ! ,,nda hold] or biological product lic5se hold] is incorporat$ z ( ! date t ! ,,nda or biological product lic5se application1 z applicable1 is fil$ ) ! ,commission] ( ,food & ,drugs2 or 7iii7 ! ,unit$ ,/ates ,c\rt ( ,appeals = ! circuit 9 :i* ! ultimate p>5t entity ( ! ,,&a fil] or biosimil> biological product application fil] is incorporat$ z ( ! date t ! ,,&a or biosimil> biological product application is fil$ ) ! ,commission] ( ,food & ,drugs4 7,b7 ,treatm5t ( f9d+s ,9 a proce$+ = judicial review ( a f9al ord] ( ! ,commission1 ! f9d+s ( ! ,commission z to ! facts1 if support$ by evid5ce1 %all be conclusive4 7e7 ,antitru/ laws ,no?+ 9 ?is section %all modify1 impair1 limit1 or sup]s$e ! applicability ( ! antitru/ laws z def9$ 9 subsection 7a7 ( ! fir/ section ( ! ,clayton ,act 7#ae ,u4,s4,c4 #ab7;a771 & ( section #e ( ?is ,act to ! ext5t t section #e applies to unfair me?ods ( competition4 ,no?+ 9 ?is section %all modify1 impair1 limit1 or sup]s$e ! "r ( an ,,&a fil] or biosimil> biological product application fil] to ass]t claims or c\nt]claims aga9/ any p]son1 "u ! antitru/ laws or o!r laws relat+ to unfair competition4 7f7 ,p5alties 7#a7 ,=feiture ,ea* p>ty t violates or assi/s 9 ! violation ( ?is section %all =feit & pay to ! ,unit$ ,/ates a civil p5alty suffici5t to det] violations ( ?is section1 b 9 no ev5t great] ?an #c times ! value receiv$ by ! p>ty t is reasonably attributable to ! violation ( ?is section4 ,if no su* value has be5 receiv$ by ! ,,nda hold] or biological product lic5se hold]1 ! p5alty to ! ,,nda hold] or biological product lic5se hold] %all be suffici5t to det] violations1 b 9 no ev5t great] ?an #c times ! value giv5 to ! ,,&a fil] or biosimil> biological product application fil] reasonably attributable to ! violation ( ?is section4 ,su* p5alty %all accrue to ! ,unit$ ,/ates & may be recov]$ 9 a civil action br\ght by ! ,commission1 9 its own "n by any ( its attorneys designat$ by x = su* purpose1 9 a di/rict c\rt ( ! ,unit$ ,/ates aga9/ any p>ty t violates ?is section4 ,9 su* actions1 ! ,unit$ ,/ates di/rict c\rts are emp[]$ to grant m&atory injunctions & su* o!r & fur!r equitable relief z !y deem appropriate4 7#b7 ,cease & desi/ 7,a7 ,9 g5]al ,if ! ,commission has issu$ a cease & desi/ ord] ) respect to a p>ty 9 an adm9i/rative adjudicative proce$+ "u ! au?ority ( subsection 7a77#a71 an action br\ght pursuant to p>agraph 7#a7 may be comm5c$ aga9/ su* p>ty at any "t be=e ! expiration ( #a ye> aft] su* ord] becomes f9al pursuant to section #e7;g74 7,b7 ,exception ,9 an action "u subp>agraph 7,a71 ! f9d+s ( ! ,commission z to ! mat]ial facts 9 ! adm9i/rative adjudicative proce$+ ) respect to ! violation ( ?is section by a p>ty %all be conclusive unless-- 7i7 ! t]ms ( su* cease & desi/ ord] expressly provide t ! ,commission's f9d+s %all n be conclusive2 or 7ii7 ! ord] became f9al by reason ( section #e7;g77#a71 9 :i* case su* f9d+ %all be conclusive if support$ by evid5ce4 7#c7 ,civil p5alty ,9 det]m9+ ! am\nt ( ! civil p5alty describ$ 9 ?is section1 ! c\rt %all take into acc\nt-- 7,a7 ! nature1 circum/ances1 ext5t1 & gravity ( ! violation2 7,b7 ) respect to ! violator1 ! degree ( culpability1 any hi/ory ( violations1 ! ability to pay1 any effect on ! ability to cont9ue do+ bus9ess1 pr(its e>n$ by ! ,,nda hold] or biological product lic5se hold]1 comp5sation receiv$ by ! ,,&a fil] or biosimil> biological product application fil]1 & ! am\nt ( comm]ce affect$2 & 7,c7 o!r matt]s t ju/ice requires4 7#d7 ,rem$ies 9 addition ,rem$ies provid$ 9 ?is subsection are 9 addition to1 & n 9 lieu (1 any o!r rem$y provid$ by ,f$]al law4 ,no?+ 9 ?is p>agraph %all be con/ru$ to affect any au?ority ( ! ,commission "u any o!r provision ( law4 7g7 ,def9itions ,9 ?is section3 7#a7 ,agreem5t ,! t]m agreem5t means any?+ t w\ld con/itute an agreem5t "u section #a ( ! ,%]man ,act 7#ae ,u4,s4,c4 #a7 or section #e ( ?is ,act4 7#b7 ,agreem5t resolv+ or settl+ a pat5t infr+em5t claim ,! t]m agreem5t resolv+ or settl+ a pat5t infr+em5t claim includes any agreem5t t is ent]$ into )9 #cj days ( ! resolution or ! settlem5t ( ! claim1 or any o!r agreem5t t is cont+5t ^u1 provides a cont+5t condition =1 or is o!rwise relat$ to ! resolution or settlem5t ( ! claim4 7#c7 ,,&a ,! t]m ,,&a means an abbreviat$ new drug application fil$ "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 or a new drug application fil$ "u section #eje7;b77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#b774 7#d7 ,,&a fil] ,! t]m ,,&a fil] means a p>ty t owns or controls an ,,&a fil$ ) ! ,food & ,drug ,adm9i/ration or has ! exclusive rights "u su* ,,&a to di/ribute ! ,,&a product4 7#e7 ,,&a product ,! t]m ,,&a product means ! product to be manufactur$ "u ! ,,&a t is ! subject ( ! pat5t infr+em5t claim4 7#f7 ,biological product ,! t]m biological product has ! mean+ giv5 su* t]m 9 section #cea7;i77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;i77#a774 7#g7 ,biological product lic5se application ,! t]m biological product lic5se application means an application "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a774 7#h7 ,biological product lic5se hold] ,! t]m biological product lic5se hold] means-- 7,a7 ! hold] ( an approv$ biological product lic5se application = a biological product2 7,b7 a p]son own+ or controll+ en=cem5t ( any pat5ts t claim ! biological product t is ! subject ( su* approv$ application2 or 7,c7 ! pr$ecessors1 subsidi>ies1 divisions1 gr\ps1 & affiliates controll$ by1 controll+1 or "u common control ) any ( ! entities describ$ 9 subp>agraphs 7,a7 & 7,b7 7su* control to be presum$ by direct or indirect %>e own]%ip ( #ej p]c5t or great]71 z well z ! lic5sees1 lic5sors1 successors1 & assigns ( ea* ( ! entities4 7#i7 ,biosimil> biological product ,! t]m biosimil> biological product means ! product to be manufactur$ "u ! biosimil> biological product application t is ! subject ( ! pat5t infr+em5t claim4 7#aj7 ,biosimil> biological product application ,! t]m biosimil> biological product application means an application "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77 = lic5sure ( a biological product z biosimil> to1 or int]*angeable )1 a ref]5ce product4 7#aa7 ,biosimil> biological product application fil] ,! t]m biosimil> biological product application fil] means a p>ty t owns or controls a biosimil> biological product application fil$ ) ! ,food & ,drug ,adm9i/ration or has ! exclusive rights "u su* application to di/ribute ! biosimil> biological product4 7#ab7 ,drug product ,! t]m drug product has ! mean+ giv5 su* t]m 9 section #cad4c7;b7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulation74 7#ac7 ,,nda ,! t]m ,,nda means a new drug application fil$ "u section #eje7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b774 7#ad7 ,,nda hold] ,! t]m ,,nda hold] means-- 7,a7 ! hold] ( an approv$ ,,nda application = a drug product2 7,b7 a p]son own+ or controll+ en=cem5t ( ! pat5t li/$ 9 ! ,approv$ ,drug ,products ,) ,!rapeutic ,equival5ce ,evaluations 7commonly kn[n z ! ,,fda ,orange ,book7 9 connection ) ! ,,nda2 or 7,c7 ! pr$ecessors1 subsidi>ies1 divisions1 gr\ps1 & affiliates controll$ by1 controll+1 or "u common control ) any ( ! entities describ$ 9 subp>agraphs 7,a7 & 7,b7 7su* control to be presum$ by direct or indirect %>e own]%ip ( #ej p]c5t or great]71 z well z ! lic5sees1 lic5sors1 successors1 & assigns ( ea* ( ! entities4 7#ae7 ,p>ty ,! t]m p>ty means any p]son1 p>tn]%ip1 corporation1 or o!r legal entity4 7#af7 ,pat5t infr+em5t ,! t]m pat5t infr+em5t means infr+em5t ( any pat5t or ( any fil$ pat5t application1 ext5sion1 reissue1 r5ewal1 division1 cont9uation1 cont9uation 9 "p1 reexam9ation1 pat5t t]m re/oration1 pat5ts ( addition1 & ext5sions !re(4 7#ag7 ,pat5t infr+em5t claim ,! t]m pat5t infr+em5t claim means any allegation made to an ,,&a fil] or biosimil> biological product application fil]1 :e!r or n includ$ 9 a compla9t fil$ ) a c\rt ( law1 t its ,,&a or ,,&a product1 or biological product lic5se application or biological product1 may infr+e any pat5t held by1 or exclusively lic5s$ to1 ! ,,nda hold] or biological product lic5se hold] ( ! drug product or biological product1 z applicable4 7#ah7 ,/atutory exclusivity ,! t]m /atutory exclusivity means ^? prohibitions on ! approval ( drug applications "u clauses 7ii7 ?r\gh 7iv7 ( section #eje7;c77#c77;,e7 7#e- & #c-ye> data exclusivity71 section #ebg 7orphan drug exclusivity71 or section #eje;,a 7p$iatric exclusivity7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77#c77;,e71 #cfj;cc1 #cee;a71 or on ! lic5s+ ( biological product applications "u section #cea7k77#g7 7#ab-ye> exclusivity7 or p>agraph 7#b7 or 7#c7 ( section #cea7m7 7p$iatric exclusivity7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 or "u section #ebg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7orphan drug exclusivity74 4 7b7 ,effective date ,section #bg ( ! ,f$]al ,trade ,commission ,act1 z add$ by ?is section1 %all apply to all agreem5ts describ$ 9 section #bg7;a77#a7 ( t ,act ent]$ into aft] ,june #ag1 #bjac4 ,section #bg7;f7 ( ! ,f$]al ,trade ,commission ,act1 z add$ by ?is section1 %all apply to agreem5ts ent]$ into on or aft] ! date ( enactm5t ( ?is ,act4 #djb4 #ahj-;day exclusivity p]iod am5dm5ts reg>d+ fir/ applicant /atus 7a7 ,am5dm5ts to ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#a7 ,9 g5]al ,section #eje7;j77#e77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,b77 is am5d$-- 7,a7 9 clause 7iv77,,ii7-- 7i7 by /rik+ item 7bb72 & 7ii7 by r$esignat+ items 7cc7 & 7dd7 z items 7bb7 & 7cc71 respectively2 & 7,b7 by add+ at ! end ! foll[+3 7v7 ,fir/ applicant def9$ ,z us$ 9 ?is subsection1 ! t]m fir/ applicant means an applicant-- 7,i7 7aa7 t1 on ! fir/ day on :i* a sub/antially complete application conta9+ a c]tification describ$ 9 p>agraph 7#b77;,a77vii77,,iv7 is submitt$ = approval ( a drug1 submits a sub/antially complete application t conta9s & lawfully ma9ta9s a c]tification describ$ 9 p>agraph 7#b77;,a77vii77,,iv7 = ! drug2 & 7bb7 t has n ent]$ into a disqualify+ agreem5t describ$ "u clause 7vii77,,ii72 or 7,,ii7 7aa7 = ! drug t is n describ$ 9 subclause 7,i7 & t1 ) respect to ! applicant & drug1 ea* requirem5t describ$ 9 clause 7vi7 is satisfi$2 & 7bb7 t has n ent]$ into a disqualify+ agreem5t describ$ "u clause 7vii77,,ii74 7vi7 ,requirem5t ,! requirem5ts describ$ 9 ?is clause are ! foll[+3 7,i7 ,! applicant describ$ 9 clause 7v77,,ii7 submitt$ & lawfully ma9ta9s a c]tification describ$ 9 p>agraph 7#b77;,a77vii77,,iv7 or a /atem5t describ$ 9 p>agraph 7#b77;,a77viii7 = ea* unexpir$ pat5t = :i* a fir/ applicant describ$ 9 clause 7v77,i7 _h submitt$ a c]tification describ$ 9 p>agraph 7#b77;,a77vii77,,iv7 on ! fir/ day on :i* a sub/antially complete application conta9+ su* a c]tification 0 submitt$4 7,,ii7 ,) reg>d to ea* su* unexpir$ pat5t = :i* ! applicant describ$ 9 clause 7v77,,ii7 submitt$ a c]tification describ$ 9 p>agraph 7#b77;,a77vii77,,iv71 no action = pat5t infr+em5t 0 br\ght aga9/ su* applicant )9 ! #de-;day p]iod specifi$ 9 p>agraph 7#e77;,b77iii72 or if an action 0 br\ght )9 su* "t p]iod1 su* an action 0 )drawn or dismiss$ by a c\rt 7includ+ a di/rict c\rt7 )\t a decision t ! pat5t 0 valid & infr+$2 or if an action 0 br\ght )9 su* "t p]iod & 0 n )drawn or s dismiss$1 su* applicant has obta9$ ! decision ( a c\rt 7includ+ a di/rict c\rt7 t ! pat5t is invalid or n infr+$ 7includ+ any sub/antive det]m9ation t !re is no cause ( action = pat5t infr+em5t or invalidity1 & includ+ a settlem5t ord] or cons5t decree sign$ & ent]$ by ! c\rt /at+ t ! pat5t is invalid or n infr+$74 7,,iii7 ,if an applicant describ$ 9 clause 7v77,i7 has begun comm]cial m>ket+ ( su* drug1 ! applicant describ$ 9 clause 7v77,,ii7 does n beg9 comm]cial m>ket+ ( su* drug until ! date t is #cj days aft] ! date on :i* ! applicant describ$ 9 clause 7v77,i7 began su* comm]cial m>ket+4 4 7#b7 ,con=m+ am5dm5t ,section #eje7;j77#e77;,d77i77,,iv7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,d77i77,,iv77 is am5d$ by /rik+ ,! fir/ applicant & ins]t+ ,! fir/ applicant1 z def9$ 9 subp>agraph 7,b77v77,i714 7b7 ,applicability ,! am5dm5ts made by subsection 7a7 %all apply only ) respect to an application fil$ "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 to :i* ! am5dm5ts made by section #aajb7;a7 ( ! ,m$ic>e ,prescription ,drug1 ,improvem5t1 & ,mod]nization ,act ( #bjjc 7,public ,law #ajh-agc7 apply4 #djc4 #ahj-;day exclusivity p]iod am5dm5ts reg>d+ agreem5ts to def] comm]cial m>ket+ 7a7 ,am5dm5ts to ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#a7 ,limitations on agreem5ts to def] comm]cial m>ket+ date ,section #eje7;j77#e77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,b771 z am5d$ by section #djb1 is fur!r am5d$ by add+ at ! end ! foll[+3 7vii7 ,agreem5t by fir/ applicant to def] comm]cial m>ket+2 limitation on accel]ation ( def]r$ comm]cial m>ket+ date 7,i7 ,agreem5t to def] approval or comm]cial m>ket+ date ,an agreem5t describ$ 9 ?is subclause is an agreem5t betwe5 a fir/ applicant & ! hold] ( ! application = ! li/$ drug or an own] ( "o or m ( ! pat5ts z to :i* any applicant submitt$ a c]tification qualify+ su* applicant = ! #ahj-;day exclusivity p]iod :]eby t applicant agrees1 directly or indirectly1 7aa7 n to seek an approval ( its application t is made effective on ! e>lie/ possible date "u ?is subp>agraph1 subp>agraph 7,f7 ( ?is p>agraph1 section #eje;,a1 or section #ebg1 7bb7 n to beg9 ! comm]cial m>ket+ ( its drug on ! e>lie/ possible date aft] receiv+ an approval ( its application t is made effective "u ?is subp>agraph1 subp>agraph 7,f7 ( ?is p>agraph1 section #eje;,a1 or section #ebg1 or 7cc7 to bo? items 7aa7 & 7bb74 7,,ii7 ,agreem5t t disqualifies applicant f fir/ applicant /atus ,an agreem5t describ$ 9 ?is subclause is an agreem5t betwe5 an applicant & ! hold] ( ! application = ! li/$ drug or an own] ( "o or m ( ! pat5ts z to :i* any applicant submitt$ a c]tification qualify+ su* applicant = ! #ahj-;day exclusivity p]iod :]eby t applicant agrees1 directly or indirectly1 n to seek an approval ( its application or n to beg9 ! comm]cial m>ket+ ( its drug until a date t is aft] ! expiration ( ! #ahj-;day exclusivity p]iod aw>d$ to ano!r applicant ) respect to su* drug 7)\t reg>d to :e!r su* #ahj-;day exclusivity p]iod is aw>d$ be=e or aft] ! date ( ! agreem5t74 7viii7 ,limitation on accel]ation ,if an agreem5t describ$ 9 clause 7vii77,i7 includes m ?an #a possible date :5 an applicant may seek an approval ( its application or beg9 ! comm]cial m>ket+ ( its drug-- 7,i7 ! applicant may seek an approval ( its application or beg9 su* comm]cial m>ket+ on ! date t is ! e>li] (-- 7aa7 ! late/ date set =? 9 ! agreem5t on :i* t applicant c receive an approval t is made effective "u ?is subp>agraph1 subp>agraph 7,f7 ( ?is p>agraph1 section #eje;,a1 or section #ebg1 or beg9 ! comm]cial m>ket+ ( su* drug1 )\t reg>d to any o!r provision ( su* agreem5t pursuant to :i* ! comm]cial m>ket+ c\ld beg9 on an e>li] date2 or 7bb7 #ahj days aft] ano!r fir/ applicant beg9s comm]cial m>ket+ ( su* drug2 & 7,,ii7 ! late/ date set =? 9 ! agreem5t on :i* t applicant c receive an approval t is made effective "u ?is subp>agraph1 subp>agraph 7,f7 ( ?is p>agraph1 section #eje;,a1 or section #ebg1 or beg9 ! comm]cial m>ket+ ( su* drug1 )\t reg>d to any o!r provision ( su* agreem5t pursuant to :i* comm]cial m>ket+ c\ld beg9 on an e>li] date1 %all be ! date us$ to det]m9e :e!r an applicant is disqualifi$ f fir/ applicant /atus pursuant to clause 7vii77,,ii74 4 7#b7 ,notification ( ,,fda ,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#ad7 7,a7 ,! hold] ( an abbreviat$ application "u ?is subsection %all submit to ! ,secret>y a notification t includes-- 7i7 7,i7 ! text ( any agreem5t ent]$ into by su* hold] describ$ "u p>agraph 7#e77;,b77vii77,i72 or 7,,ii7 if su* an agreem5t has n be5 r$uc$ to text1 a writt5 detail$ description ( su* agreem5t t is suffici5t to disclose all ! t]ms & conditions ( ! agreem5t2 & 7ii7 ! text1 or a writt5 detail$ description 9 ! ev5t ( an agreem5t t has n be5 r$uc$ to text1 ( any o!r agreem5ts t are cont+5t ^u1 provide a cont+5t condition =1 or are o!rwise relat$ to an agreem5t describ$ 9 clause 7i74 7,b7 ,! notification describ$ "u subp>agraph 7,a7 %all be submitt$ n lat] ?an #aj bus9ess days aft] execution ( ! agreem5t describ$ 9 subp>agraph 7,a77i74 ,su* notification is 9 addition to any notification requir$ "u section #aaab ( ! ,m$ic>e ,prescription ,drug1 ,improvem5t1 & ,mod]nization ,act ( #bjjc4 7,c7 ,any in=mation or docum5t>y mat]ial fil$ ) ! ,secret>y pursuant to ?is p>agraph %all be exempt f disclosure "u section #eeb ( title #e1 ,unit$ ,/ates ,code1 & no su* in=mation or docum5t>y mat]ial may be made public1 except z may be relevant to any adm9i/rative or judicial action or proce$+4 ,no?+ 9 ?is p>agraph is int5d$ to prev5t disclosure to ei!r body ( ! ,congress or to any duly au?oriz$ committee or subcommittee ( ! ,congress4 4 7#c7 ,prohibit$ acts ,section #cja7;e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7;e77 is am5d$ by /rik+ #eje 7i7 or 7k7 & ins]t+ #eje 7i71 7j77#aa71 or 7k74 7b7 ,infr+em5t ( pat5t ,section #bga7;e7 ( title #ce1 ,unit$ ,/ates ,code1 is am5d$ by add+ at ! end ! foll[+3 7#g7 ,! exclusive rem$y "u ?is section = an infr+em5t ( a pat5t = :i* ! ,secret>y ( ,heal? & ,human ,s]vices has publi%$ in=mation pursuant to subsection 7b77#a7 or 7c77#b7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act %all be an action br\ght "u ?is subsection )9 ! #de-;day p]iod describ$ 9 subsection 7j77#e77;,b77iii7 or 7c77#c77;,c7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 4 7c7 ,applicability 7#a7 ,limitations on accel]ation ( def]r$ comm]cial m>ket+ date ,! am5dm5t made by subsection 7a77#a7 %all apply only ) respect to-- 7,a7 an application fil$ "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 to :i* ! am5dm5ts made by section #aajb7;a7 ( ! ,m$ic>e ,prescription ,drug1 ,improvem5t1 & ,mod]nization ,act ( #bjjc 7,public ,law #ajh-agc7 apply2 & 7,b7 an agreem5t describ$ "u section #eje7;j77#e77;,b77vii77,i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by subsection 7a77#a77 execut$ aft] ! date ( enactm5t ( ?is ,act4 7#b7 ,notification ( ,,fda ,! am5dm5ts made by p>agraphs 7#b7 & 7#c7 ( subsection 7a7 %all apply only ) respect to an agreem5t describ$ "u section #eje7;j77#e77;,b77vii77,i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by subsection 7a77#a77 execut$ aft] ! date ( enactm5t ( ?is ,act4 #djd4 ,increas+ drug competition & prev5t+ drug %ortages ,section #eje7;j77#g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 is am5d$ by add+ at ! end ! foll[+3 7,d7 7i7 ,! ,commission] %all-- 7,i7 n lat] ?an #i mon?s aft] ! date ( enactm5t ( ! ,af=dable ,m$ications ,act1 publi% a complete1 up-to-date li/ on ! int]net website ( ! ,food & ,drug ,adm9i/ration ( all drugs1 includ+ au?oriz$ g5]ics1 toge!r )1 ) respect to ! drug1 z applicable-- 7aa7 ! drug trade "n2 7bb7 ! e/abli%$ "n2 7cc7 ea* active ph>maceutical +r$i5t facility 7z def9$ 9 section #gdd;,b7a77#d77;a77ii772 7dd7 ea* g5]ic drug facility2 7ee7 ea* contract manufactur+ organization facility 7z def9$ 9 section #gdd;,a7#e772 7ff7 ! date any au?oriz$ g5]ic drug ent]$ ! m>ket2 7gg7 ! m>ket+ /atus2 & 7hh7 any o!r in=mation ! ,secret>y may require to mitigate or prev5t drug %ortages2 7,,ii7 designate ea* drug on ! li/ t is a sole-s\rce g5]ic drug2 7,,iii7 designate ea* drug on ! li/ t is an ess5tial m$ic9e1 z id5tifi$ by ! ,_w ,heal? ,organization1 or ano!r entity designat$ by ! ,secret>y t meets evid5ce-bas$ /&>ds z requir$ by ! ,secret>y2 & 7,,iv7 ma9ta9 a confid5tial li/ ( ! id5tity & address ( ea* facility describ$ 9 subclause 7,i71 & publicly report on ! website only ! city & ,/ate or c\ntry ( ea* su* facility4 7ii7 ,! ,commission] may *oose n to make in=mation collect$ "u clause 7i7 publicly available if ! ,secret>y det]m9es t disclosure ( su* in=mation w\ld adv]sely affect ! public heal? 7su* z by increas+ ! possibility ( ho>d+ or o!r disruption ( ! availability ( drug products to pati5ts74 7iii7 ,! ,commission] %all notify relevant ,f$]al ag5cies1 includ+ ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices & ! ,f$]al ,trade ,commission1 :5 ! ,commission] fir/ publi%es ! in=mation "u clause 7i7 t ! in=mation has be5 publi%$ & w be updat$ regul>ly4 7iv7 ,9 ?is subp>agraph1 ! t]m sole-s\rce means1 ) respect to a drug1 !re is n m ?an "o approv$ drug on ! li/ ( drugs "u subp>agraph 7,a71 n includ+ drugs on ! discont9u$ section ( su* li/4 4 #dje4 ,disall[ance ( d$uction = adv]tis+ = prescription drugs 7a7 ,9 g5]al ,"p ,,ix ( sub*apt] ,b ( *apt] #a ( subtitle ,a ( ! ,int]nal ,rev5ue ,code ( #aihf 7relat+ to items n d$uctible7 is am5d$ by add+ at ! end ! foll[+ new section3 #bhj;,i4 ,disall[ance ( d$uction = direct-to-consum] adv]tis+ ( prescription drugs 7a7 ,9 g5]al ,no d$uction %all be all[$ "u ?is *apt] = exp5ses relat+ to direct-to-consum] adv]tis+ ( prescription drugs = any taxable ye>4 7b7 ,direct-to-,consum] adv]tis+ ,= purposes ( ?is section1 ! t]m direct-to-consum] adv]tis+ means any dissem9ation1 by or on behalf ( a sponsor ( a prescription drug product 7z su* t]m is def9$ 9 section #gce7c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act71 ( an adv]tisem5t :i*-- 7#a7 is 9 reg>d to su* prescription drug product1 & 7#b7 prim>ily t>get$ to ! g5]al public1 includ+ ?r\gh-- 7,a7 publication 9 j\rnals1 magaz9es1 o!r p]iodicals1 & newspap]s1 7,b7 broadca/+ ?r\gh m$ia su* z radio1 television1 telephone communication sy/ems1 direct mail1 & billbo>ds1 7,c7 dissem9ation on ! int]net 7includ+ social m$ia71 & 7,d7 manufactur] pati5t assi/ance programs1 z def9$ 9 section #cii,v-#g ( ! ,public ,heal? ,s]vice ,act4 4 7b7 ,con=m+ am5dm5t ,! table ( sections = su* "p ,,ix ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ aft] ! item relat+ to section #bhj;,h ! foll[+ new item3 ,sec4 #bhj;,i4 ,disall[ance ( d$uction = direct-to-consum] adv]tis+ ( prescription drugs4 4 7c7 ,effective date ,! am5dm5ts made by subsections 7a7 & 7b7 %all apply to am\nts paid or incurr$ aft] ! date ( ! enactm5t ( ?is ,act1 9 taxable ye>s end+ aft] su* date4 7d7 ,ov]sight ( prescription drugs 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is subsection z ! ,secret>y71 act+ ?r\gh ! ,commission] ( ,food & ,drugs & 9 coord9ation ) o!r ,f$]al ag5cies1 %all conduct ov]sight ( ! risks & b5efits ( drugs t are on ! m>ket & h[ su* risks are pres5t$ 9 drug adv]tisem5ts = ! purpose ( correct+ false or mislead+ in=mation publi%$ 9 direct-to-consum] adv]tisem5ts & to dissem9ate corrective in=mation to heal? c>e provid]s & ! g5]al public reg>d+ ! risks & b5efits ( a drug on an qu>t]ly basis4 7#b7 ,pr]eview ( television adv]tisem5ts ,! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs & 9 consultation ) relevant /akehold]s1 %all issue new1 or update curr5t1 guidance issu$ "u section #ejc;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;c74 ,9 c>ry+ out ?is p>agraph1 ! ,secret>y %all focus on drugs t pres5t ! greate/ risk to consum]s1 drugs t repres5t ! greate/ proportion ( total sp5d+ 9 ,f$]al programs1 drugs ) high unit price increases ov] ! prec$+ ye>1 drugs ) high laun* prices1 or any o!r priority drugs id5tifi$ by ! ,secret>y4 7#c7 ,fund+ ,!re is au?oriz$ to be appropriat$ to ! ,secret>y an am\nt equal to ! increase 9 rev5ue result+ f ! enactm5t ( section #bhj;,i ( ! ,int]nal ,rev5ue ,code ( #aihf1 z add$ by subsection 7a74 #djf4 ,drug manufactur] duty to disclose drug prices to practition]s 7a7 ,duty ,to disclose ,:5ev] a drug manufactur]1 includ+ any repres5tative ( ! manufactur]1 communicates ) a heal? c>e practition] ab\t a drug manufactur$ by ! drug manufactur]1 includ+ ?r\gh promotional1 educational1 or m>ket+ communications1 meet+s or paid ev5ts1 & ! provision ( goods1 gifts1 & samples1 ! drug manufactur] %all disclose to ! practition] ! :olesale acquisition co/ 7z def9$ 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b777 = a #cj-;day supply ( ! drug1 :i* may include a brief qualitative explanation ( r$uc$ co/ availability = c]ta9 consum]s4 7b7 ,en=cem5t by ,f$]al ,trade ,commission 7#a7 ,unfair or deceptive acts or practices ,a violation ( subsection 7a7 by a p]son ) respect to :om ! ,commission is emp[]$ "u section #e7;a77#b7 ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7;a77#b77 %all be treat$ z a violation ( a rule def9+ an unfair or deceptive act or practice prescrib$ "u section #ah7;a77#a77;,b7 ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #eg;a7a77#a77;,b774 7#b7 ,p[]s ( ,f$]al ,trade ,commission 7,a7 ,9 g5]al ,! ,f$]al ,trade ,commission %all en=ce ?is section 9 ! same mann]1 by ! same means1 & ) ! same jurisdiction1 p[]s1 & duties z ?\gh all applicable t]ms & provisions ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #da et seq47 7 incorporat$ into & made a "p ( ?is ,act4 7,b7 ,privileges & immunities ,any p]son :o violates ?is section %all be subject to ! p5alties & entitl$ to ! privileges & immunities provid$ 9 ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #da et seq474 7c7 ,rulemak+ ,! ,f$]al ,trade ,commission %all promulgate 9 accordance ) section #eec ( title #e1 ,unit$ ,/ates ,code1 su* rules z may be necess>y to c>ry out ?is section4 7d7 ,sav+s provision ,no?+ 9 ?is section %all be con/ru$ to limit1 impair1 or sup]s$e ! op]ation ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #da et seq47 or any o!r provision ( ,f$]al law4 #djg4 ,exclud+ au?oriz$ g5]ic drugs f calculation ( av]age manufactur] price "u ! ,m$icaid drug rebate program 7a7 ,9 g5]al ,subp>agraph 7,c7 ( section #aibg7k77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#a77 is am5d$-- 7#a7 9 ! subp>agraph head+1 by /rik+ ,inclusion & ins]t+ ,exclusion2 7#b7 by /rik+ a new drug application & ins]t+ ! manufactur]'s new drug application2 & 7#c7 by /rik+ inclusive & ins]t+ exclusive4 7b7 ,effective date ,! am5dm5ts made by ?is section %all take effect on ! fir/ day ( ! fir/ fiscal qu>t] t beg9s aft] ! date ( enactm5t ( ?is ,act4