,,ii #aaf? ,,congress #a/ ,session ,s4 #fcg ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,febru>y #bh1 #bjai,mr4 ,blum5?al 7= himself1 ,mr4 ,m]kley1 ,ms4 ,h>ris1 ,ms4 ,klobu*>1 ,mr4 ,s*atz1 & ,mr4 ,s&]s7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to prohibit price g\g+ 9 ! sale ( drugs4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,combatt+ ,unreasonable ,rises & ,excessively ,high ,drug ,prices ,act or ! ,,cure ,high ,drug ,prices ,act4 #b4 ,def9itions ,9 ?is ,act3 7#a7 ,av]age manufactur] price ,! t]m av]age manufactur] price-- 7,a7 has ! mean+ giv5 ! t]m 9 section #aibg7k7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k772 or 7,b7 ) respect to a drug = :i* !re is no av]age manufactur] price z s def9$1 means ! :olesale acquisition co/ ( ! drug4 7#b7 ,drug ,! t]m drug-- 7,a7 has ! mean+ giv5 ! t]m 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba72 & 7,b7 includes biological products1 z def9$ 9 section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 7#c7 ,f$]al heal? c>e program ,! t]m ,f$]al heal? c>e program has ! mean+ giv5 ! t]m 9 section #aabh;,b7f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;b7f774 7#d7 ,manufactur] ,! t]m manufactur] means a p]son-- 7,a7 t holds ! application = a drug approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or ! lic5se issu$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb72 or 7,b7 :o is responsible = sett+ ! price = ! drug4 7#e7 ,price g\g+ ,! t]m price g\g+ means an increase 9 ! av]age manufactur] price ( a qualify+ drug t-- 7,a7 is 9 sub/antial excess ( an am\nt t c\ld be reasonably ju/ifi$ by an increase 9 co/ ( produc+ ! drug or by an increase 9 co/ due to appropriate expansion ( access to ! drug to promote public heal?2 & 7,b7 t because ( insuffici5t competition 9 ! m>ketplace1 consum]s _c reasonably avoid4 7#f7 ,qualify+ drug ,! t]m qualify+ drug means any drug1 includ+ a comb9ation product ^: prim>y mode ( action is det]m9$ "u section #ejc7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;g77 to be t ( a drug1 t-- 7,a7 is subject to section #ejc7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;b77#a772 & 7,b7 is cov]$ by a ,f$]al heal? c>e program4 7#g7 ,secret>y ,! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices4 #c4 ,price g\g+ prohibit$ 7a7 ,9 g5]al ,a manufactur] %all n engage 9 price g\g+ 9 ! sale ( a qualify+ drug4 7b7 ,presumption ,price g\g+ %all be presum$ if ! av]age manufactur] price has increas$-- 7#a7 #aj p]c5t or m )9 ! previ\s #ab-mon? p]iod2 7#b7 #bj p]c5t or m 9 ! previ\s #cf-mon? p]iod2 or 7#c7 #cj p]c5t or m )9 ! previ\s #fj-mon? p]iod4 7c7 ,notice by ,secret>y ,! ,secret>y %all notify ! manufactur] ( an increase1 )9 ! previ\s #b ye>s1 9 ! av]age manufactur] price ( a qualify+ drug ! ,secret>y has reason to believe con/itutes price g\g+1 by s5d+ notice to ! manufactur]1 reque/+ a /atem5t ( ju/ification = ! increase1 :i* may include-- 7#a7 itemiz+ ! compon5ts ( ! co/ ( produc+ ! qualify+ drug2 7#b7 id5tify+ ! circum/ances & tim+ ( an increase 9 mat]ials or manufactur+ co/s t caus$ an increase 9 ! av]age manufactur] price ( ! qualify+ drug )9 ! #e-ye> p]iod prec$+ ! date ( ! av]age manufactur] price increase2 7#c7 id5tify+ ! circum/ances & tim+ ( any exp5ditures made by ! manufactur] to exp& access to ! qualify+ drug & expla9+ any improvem5t 9 public heal? associat$ ) ^? exp5ditures2 7#d7 provid+ sales & price in=mation = o!r qualify+ drugs ) simil> !rapeutic effects1 z relevant to assess+ ! ext5t ( competition 9 ! m>ketplace1 & ! *oice available to consum]s2 & 7#e7 provid+ any o!r in=mation t ! manufactur] believes to be relevant to a det]m9ation ( :e!r a violation ( ?is ,act has occurr$4 7d7 ,/atem5t ,n lat] ?an #de days aft] ! date on :i* a manufactur] receives a /atem5t "u subsection 7c71 ! manufactur] %all submit to ! ,secret>y a /atem5t describ$ 9 subsection 7c74 7e7 ,det]m9ation by ,secret>y ,if ! ,secret>y det]m9es1 aft] review ( ! /atem5t ( ju/ification1 or bas$ on reasonable belief if ! manufactur] fails to submit a /atem5t ( ju/ification z requir$1 t ! manufactur] has engag$ 9 price g\g+ ) respect to a qualify+ drug1 ! ,secret>y %all notify ! manufactur] ( ! det]m9ation4 7f7 ,rem$y 7#a7 ,9 g5]al ,! ,secret>y may ord] t a manufactur] det]m9$ "u subsection 7e7 to h engag$ 9 price g\g+ ) respect to a qualify+ drug-- 7,a7 re/ore to any consum]1 includ+ a ?ird-p>ty payor1 any excessive am\nt paid z a result ( a price increase t violates ?is ,act2 7,b7 make ! drug available to p>ticipants ( any qualifi$ heal? plan or ,f$]al heal? plan = a p]iod ( up to #a ye> at ! price at :i* ! drug 0 made available to consum]s imm$iately be=e ! violation ( ?is ,act2 or 7,c7 if ! price g\g+ is done kn[+ly1 or occurs aft] a previ\s det]m9ation by ! ,secret>y or price g\g+ by ! manufactur]1 pay a civil p5alty ( up to #c times ! excessive am\nt ! manufactur] receiv$ z a result ( a violation ( ?is ,act4 7#b7 ,appeals ,any p]son adv]sely affect$ by a det]m9ation ( ! ,secret>y "u ?is subsection may obta9 review ( ! det]m9ation 9 accordance ) section #aabh;,a7e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;a7e774 7g7 ,en=cem5t by ,attorney ,g5]al 7#a7 ,9 g5]al ,if a manufactur] det]m9$ "u subsection 7e7 to h engag$ 9 price g\g+ fails to comply ) an ord] ( ! ,secret>y "u subsection 7f71 ! ,secret>y may ref] ! matt] to ! ,attorney ,g5]al = en=cem5t4 7#b7 ,subpo5as ,! ,attorney ,g5]al may subpo5a docum5ts or te/imony z may assi/ 9 e/abli%+ :e!r ! manufactur] engag$ 9 price g\g+ 9 violation ( ?is ,act4 7#c7 ,action ,! ,attorney ,g5]al may br+ an action 9 an appropriate di/rict c\rt = relief1 includ+ any relief describ$ 9 subsection 7f7 & su* fur!r relief z ! c\rt det]m9es is appropriate4 #d4 ,effective date2 applicability ,?is ,act %all-- 7#a7 take effect on ,janu>y #a1 #bjbj2 & 7#b7 apply ) respect to all increases 9 ! av]age manufactur] price ( a qualify+ drug occurr+ on or aft] t date4