,i #aae? ,,congress #a/ ,session ,h4 ,r4 #daaf ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,octob] #be1 #bjag,mr4 ,doggett 7= himself1 ,mr4 ,cumm+s1 ,ms4 ,de,lauro1 ,mr4 ,ellison1 ,mr4 ,pocan1 ,mr4 ,grijalva1 ,mr4 ,cicill9e1 ,mr4 ,coh51 ,mr4 ,cony]s1 ,mr4 ,higg9s ( ,new ,york1 ,ms4 ,kaptur1 ,mr4 ,nadl]1 & ,mr4 ,rask97 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,public ,heal? ,s]vice ,act to require report+ by drug manufactur]s to increase transp>5cy 9 drug pric+1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,transp>5t ,drug ,pric+ ,act ( #bjag4 #b4 ,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 ,m&atory report+ ,a drug manufactur] %all submit to ! ,secret>y & to ,congress an annual report specify+ ) respect to ! previ\s cal5d> ye> 7except z provid$ 9 subsection 7d77#b77-- 7#a7 ! total exp5ditures ( ! manufactur] on-- 7,a7 dome/ic & =eign drug rese>* & developm5t1 includ+ an itemiz$ description (-- 7i7 basic & precl9ical rese>*2 7ii7 cl9ical rese>*1 report$ sep>ately = ea* cl9ical trial2 7iii7 developm5t ( alt]native dosage =ms & /r5g?s = ! drug molecule or comb9ations1 includ+ ! molecule2 7iv7 o!r drug developm5t activities1 su* z noncl9ical laboratory /udies & record & report ma9t5ance2 7v7 pursu+ new or exp&$ indications = su* drug ?r\gh supplem5tal applications "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 7vi7 c>ry+ out po/m>ket requirem5ts relat$ to su* drug1 includ+ "u section #eje7o77#c7 ( su* ,act2 7vii7 c>ry+ out risk evaluation & mitigation /rategies 9 accordance ) section #eje-a ( su* ,act2 & 7viii7 m>ket+ rese>*2 7,b7 ! acquisition ( drug compon5ts & packag+1 9 total & p] unit sold1 brok5 out by s\rce & co/ & id5tify+ specific co/s t reflect int]nal transf]s )9 ! manufactur]'s company2 7,c7 o!r acquisitions relat+ to drugs1 includ+ = ! pur*ase ( pat5ts & lic5s+ or ! acquisition ( any corporate entity own+ any rights to a drug dur+ or aft] developm5t ( ! drug2 & 7,d7 m>ket+1 adv]tis+1 & educat+ = ! promotion ( a drug1 includ+ a breakd[n ( am\nts aim$ at consum]s1 prescrib]s1 manag$ c>e organizations1 & o!rs1 irrespective ( :e!r a p>ticul> drug is m5tion$ 9 ! m>ket+1 adv]tis+1 or educat+2 7#b7 ! gross rev5ue1 net rev5ue1 gross pr(it1 & net pr(it ( ! manufactur] ) respect to drugs2 7#c7 ! total numb] ( units ( ea* type ( drug t 7 sold 9 int]/ate comm]ce2 7#d7 pric+ in=mation ) respect to ! sale ( drugs1 includ+-- 7,a7 :olesale acquisition co/2 7,b7 net av]age price realiz$ by prescription drug 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 & 7,c7 ! net price ( ea* 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 any ,f$]al b5efits receiv$ by ! manufactur] ) respect to a drug1 includ+ ! am\nts & p]iods ( impact = ea* su* b5efit1 includ+ tax cr$its2 ,f$]al grants1 includ+ f ! ,national ,in/itutes ( ,heal?1 ! ,dep>tm5t ( ,def5se1 ! ,dep>tm5t ( ,en]gy1 ! ,c5t]s = ,disease ,control & ,prev5tion1 or o!r ,f$]al dep>tm5ts or ag5cies2 pat5t applications t b5efitt$ f su* grants2 pat5t ext5sions2 exclusivity p]iods2 & waiv]s ( fees2 7#f7 ! p]c5tage ( rese>* & developm5t exp5ditures describ$ 9 clauses 7i7 ?r\gh 7v7 ( p>agraph 7#a77;,a7 t 7 d]iv$ f ,f$]al funds2 7#g7 executive comp5sation = ! *ief executive (fic]1 *ief f9ancial (fic]1 & ! #c o!r mo/ highly comp5sat$ 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#h7 any o!r in=mation z ! ,secret>y may require4 7b7 ,volunt>y supplem5tal report+ ,a drug manufactur] may supplem5t a report "u subsection 7a7 ) any additional in=mation ! manufactur] *ooses to provide relat$ to drug pric+ decisions1 su* z-- 7#a7 total exp5ditures on drug rese>*1 drug developm5t1 & cl9ical trials on drugs t fail$ to receive approval by ! ,food & ,drug ,adm9i/ration2 & 7#b7 a li/ ( drugs & drug prices ( o!r manufactur]s = purposes ( comp>ison ) ! manufactur]'s own drugs & drug prices4 7c7 ,special rule ,a drug manufactur] %all-- 7#a7 to ! ext5t possible1 disaggregate ! in=mation requir$ to be report$ by ?is section by ! p>ticul> drug involv$2 & 7#b7 submit all in=mation requir$ to be report$ by ?is section ) respect to ea* applicable drug 9 a s+le annual report4 7d7 ,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 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 7#b7 ,initial report 7,a7 ,9 g5]al ,a drug manufactur] %all submit an initial report pursuant to ?is section n lat] ?an "o ye> aft] ! date ( enactm5t ( ! ,transp>5t ,drug ,pric+ ,act ( #bjag 7except z provid$ 9 subp>agraph 7,b774 7,b7 ,report+ p]iod ,not)/&+ ! requirem5t 9 subsection 7a7 t ea* report "u su* subsection be = ! previ\s cal5d> ye>1 ! initial report ( a drug manufactur] "u subsection 7a7 %all include1 = ea* drug m>ket$ by ! manufactur]1 ! in=mation describ$ 9 p>agraphs 7#a7 ?r\gh 7#f7 ( subsection 7a7 = ! cal5d> ye> p]iod beg9n+ ) ! lat] (-- 7i7 ! cal5d> ye> 9 :i* ! drug 0 approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 0 lic5s$ "u section #cea ( ?is ,act1 or receiv$ an exemption "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea7;a77#c7 ( ?is ,act2 & 7ii7 ! cal5d> ye> 9 :i* ! manufactur] acquir$ ! drug s approv$1 lic5s$1 or exempt$4 7,c7 ,small bus9esses ,9 ! case ( a drug manufactur] t has few] ?an #ejj employees1 ! initial report requir$ by 9 subp>agraph 7,a7 %all be submitt$ by a date det]m9$ by ! ,secret>y1 :i* %all be-- 7i7 n e>li] ?an ! deadl9e describ$ 9 subp>agraph 7,a72 & 7ii7 n lat] ?an ! date t is #c ye>s aft] ! date ( enactm5t ( ! ,transp>5t ,drug ,pric+ ,act ( #bjag4 7e7 ,audit by ?ird p>ty ,! ,secret>y %all select a p]c5tage 7to be det]m9$ by ! ,secret>y7 ( ! reports submitt$ "u subsection 7a7 = a fiscal ye> to be audit$ by an accr$it$ ?ird-p>ty auditor 7to be select$ by ! ,secret>y74 7f7 ,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 subsection &1 )\t fur!r appropriation1 %all use su* funds to support rese>* ( ! ,national ,in/itutes ( ,heal?4 7g7 ,def9ition ,9 ?is section1 ! t]m drug manufactur] means ! 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 ,act74 4