,i #aag? ,,congress #b;d ,session ,h4 ,r4 #gjjh ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,m>* #i1 #bjbb,mr4 ,gu?rie introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to improve pati5t access to em]g+ m$ication !rapies by cl>ify+ ! scope ( p]mitt$ heal? c>e economic & sci5tific in=mation communications betwe5 bioph>maceutical manufactur]s & population heal? decision mak]s1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,pre-approval ,in=mation ,ex*ange ,act ( #bjbb4 #b4 ,facilitat+ ex*ange ( in=mation prior to approval ,section #ejb7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7;a77 is am5d$-- 7#a7 by r$esignat+ subp>agraph 7#b7 z subp>agraph 7#c72 7#b7 by ins]t+ aft] subp>agraph 7#a7 ! foll[+3 7#b7 7,a7 ,heal? c>e economic in=mation1 sci5tific in=mation1 or product support in=mation provid$ to a cov]$ payor responsible = ! selection ( drugs or devices = cov]age1 reimbursem5t1 or o!r population-bas$ heal? c>e managem5t1 %all n be consid]$ false or mislead+ or any o!r =m ( misbr&+ "u ?is section or a violation ( section #eje1 #eaj7k71 #eac1 or #eae ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 or o!rwise prohibit$ pre-approval promotion ( a drug or device1 if x-- 7i7 7,i7 9 ! case ( heal? c>e economic in=mation1 is bas$ on compet5t & reliable sci5tific evid5ce2 or 7,,ii7 9 ! case ( sci5tific in=mation o!r ?an heal? c>e economic in=mation1 is tru?ful & nonmislead+2 & 7ii7 relates to an inve/igational drug or device or inve/igational use ( a drug or device t is approv$1 cle>$1 or lic5s$ "u section #eje1 #eaj7k71 #eac1 or #eae ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act 7z applicable74 7,b7 ,9 ord] to provide in=mation pursuant to ?is subp>agraph relat+ to an inve/igational drug or device1 or an inve/igational use ( an drug or device t has be5 approv$1 grant$ m>ket+ au?orization1 cle>$1 or lic5s$-- 7i7 ! in=mation mu/ include-- 7,i7 a cle> /atem5t t ! inve/igational drug or device or inve/igational use ( a drug or device has n be5 approv$1 cle>$1 or lic5s$ "u section #eje1 #eaj7k71 #eac1 or #eae ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act 7z applicable7 & t ! safety & effectiv5ess ( ! drug or device or use has n yet be5 e/abli%$2 7,,ii7 in=mation relat$ to ! /age ( developm5t ( ! drug or device involv$1 su* z-- 7aa7 ! /atus ( any /udy or /udies 9 :i* ! inve/igational drug or device or inve/igational use is be+ inve/igat$2 7bb7 h[ ! /udy or /udies relate to ! ov]all plan = ! developm5t ( ! drug or device2 7cc7 :e!r a m>ket+ application or notification = ! inve/igational drug or device or inve/igational use has be5 submitt$ to ! ,secret>y & :5 su* a submission is plann$2 7,,iii7 9 ! case ( communications t include factual pres5tations ( results f /udies1 a description (-- 7aa7 mat]ial aspects ( /udy design1 me?odology1 & results2 & 7bb7 mat]ial limitations relat$ to ! /udy design1 me?odology1 & results2 & 7,,iv7 :]e applicable1 a conspicu\s & prom95t /atem5t describ+ any mat]ial diff]5ces betwe5 ! in=mation provid$ & ! label+ approv$1 grant$ m>ket+ au?orization1 cle>$1 or lic5s$ pursuant to section #eje1 #eaj7k71 #eac1 or #eae ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act4 7,c7 ,= purposes ( ?is subp>agraph-- 7i7 ! t]m cov]$ payor means a payor1 =mul>y committee1 drug in=mation c5t]1 te*nology assessm5t committee1 ph>macy b5efit manag]1 & o!r multidiscipl9>y entity t1 on behalf ( heal? c>e organizations1 reviews sci5tific or te*nology assessm5ts1 or o!r simil> entity ) k & exp]tise to evaluate heal? c>e economic analysis or sci5tific in=mation on a population basis2 7ii7 ! t]m product support in=mation includes-- 7,i7 in=mation describ+ ! drug or device 7su* z drug class1 device description1 & features72 7,,ii7 in=mation ab\t ! indication or indications s\ght2 7,,iii7 ! anticipat$ timel9e = a possible approval1 cle>ance1 or lic5sure pursuant to section #eje1 #eaj7k71 #eac1 or #eae ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act2 7,,iv7 drug or device pric+ in=mation2 7,v7 pati5t utilization projections2 & 7,,vi7 product-relat$ programs or s]vices4 7iii7 ! t]m sci5tific in=mation includes cl9ical & pre-cl9ical data & results relat+ to a drug or device or use t has n be5 approv$1 grant$ m>ket+ au?orization1 cle>$1 or lic5s$ & is be+ inve/igat$ or develop$4 2 7#c7 9 subp>agraph 7#c71 z r$esignat$-- 7,a7 by /rik+ 7,a72 7,b7 by /rik+ clause 7,b72 & 7,c7 by /rik+ drug ea* place x appe>s & ins]t+ drug or device2 & 7#d7 by add+ at ! end ! foll[+3 7#d7 ,no?+ 9 ?is section %all be con/ru$ to limit ! ability ( manufactur]s or sponsors ( drugs or devices to engage 9 communications or activities n specifi$ 9 subp>agraph 7#b7 or 7#c7 t are o!rwise p]missible4 4 #c4 ,,gao /udy & report ,beg9n+ on ! date t is #e ye>s & #f mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 79 ?is subsection ref]r$ to z ! ,comptroll] ,g5]al7 %all conduct a /udy on ! provision & use ( in=mation pursuant to section #ejb7;a77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #b ( ?is ,act1 betwe5 manufactur]s (1 & cov]$ entities 7z def9$ 9 su* section #ejb7;a77#b77 =1 drugs & devices 7z def9$ 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba774 ,su* /udy %all include an analysis ( ! foll[+3 7#a7 ,! type ( in=mation communicat$ betwe5 su* manufactur]s & payors4 7#b7 ,! mann] ( communication betwe5 su* manufactur]s & payors4 7#c7 7,a7 ,:e!r su* manufactur]s file a submission = approval1 m>ket+ au?orization1 cle>ance1 or lic5s+ ( a new drug or device or ! new use ( a drug or device t is ! subject ( communication betwe5 su* manufactur]s & payors be=e ! new use is approv$1 grant$ m>ket+ au?orization1 cle>$1 or lic5s$4 7,b7 ,h[ frequ5tly ! ,food & ,drug ,adm9i/ration approves1 grants m>ket+ au?orization1 cle>s1 or lic5ses ! new drug or device or new use4 7,c7 ,! timeframe betwe5 ! initial communications "u section #ejb7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z am5d$ by ?is ,act1 reg>d+ an inve/igational drug or device or inve/igational use1 & ! initial m>ket+ ( su* drug or device or inve/igational use4