,i #aaf? ,,congress #a/ ,session ,h4 ,r4 #cidg ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,july #bd1 #bjai,mr4 ,mead[s introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committees on ,ways & ,means1 ! ,judici>y1 ,arm$ ,s]vices1 & ,ov]sight & ,re=m1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to l[] ! co/ ( prescription drugs1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,competition ,prescription ,act ( #bjai4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,title ,i--,,elim9at+ ,,delays ,,( ,,g5]ic ,,drugs ,,& ,,biosimil> ,,products ,sec4 #aja4 ,actions = delays ( g5]ic drugs & biosimil> biological products4 ,sec4 #ajb4 ,,rems approval process = subsequ5t fil]s4 ,title ,,ii--,,increas+ ,,access ,,to ,,drugs ,,& ,,biosimil> ,,products ,sec4 #bja4 ,exp$it$ developm5t & priority review = g5]ic complex drug products4 ,sec4 #bjb4 ,increas+ ph>maceutical options to treat an unmet m$ical ne$4 ,sec4 #bjc4 ,preemption ( ,/ate b>ri]s to ! sub/itution ( biosimil> products4 ,sec4 #bjd4 ,exp$it$ process = biological products au?oriz$ = m>ket+ 9 ,european ,union4 ,title ,,iii--,,prescription ,,drug ,,pric+ ,,& ,,competition ,sec4 #cja4 ,m$ic>e drug cov]age4 ,sec4 #cjb4 ,fee transp>5cy betwe5 ph>macies & ,p,b,ms4 ,sec4 #cjc4 ,sunset ( limit on maximum rebate am\nt = s+le s\rce drugs & innovator multiple s\rce drugs4 ,sec4 #cjd4 ,regulation ( manufactur]-sponsor$ copay contributions4 ,title ,,iv--,,pat5t ,,disclosure ,,requirem5ts ,sec4 #dja4 ,pat5t disclosure & transp>5cy requirem5ts4 ,sec4 #djb4 ,antitru/ exemption = heal? insurance issu]s to negotiate :olesale acquisition prices ( prescription drugs pur*as$ f drug manufactur]s4 ,sec4 #djc4 ,fair treatm5t ( ,m$ic>e "p ,b bill+ codes = ! prescrib+ ( biosimil>s4 ,title ,v--,,fix+ ,,global ,,freeload+ ,sec4 #eja4 ,*ief ,ph>maceutical ,negotiator 9 ! ,(fice ( ! ,unit$ ,/ates ,trade ,repres5tative4 ,i ,,elim9at+ ,,delays ,,( ,,g5]ic ,,drugs ,,& ,,biosimil> ,,products #aja4 ,actions = delays ( g5]ic drugs & biosimil> biological products 7a7 ,def9itions ,9 ?is section-- 7#a7 ! t]m comm]cially reasonable1 m>ket-bas$ t]ms means-- 7,a7 a nondiscrim9atory price = ! sale ( ! cov]$ product at or bel[1 b n great] ?an1 ! mo/ rec5t :olesale acquisition co/ = ! drug1 z def9$ 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b772 7,b7 a s*$ule = deliv]y t results 9 ! transf] ( ! cov]$ product to ! eligible product develop] consi/5t ) ! tim+ "u subsection 7b77#b77;,a77iv72 & 7,c7 no additional conditions are impos$ on ! sale ( ! cov]$ product2 7#b7 ! t]m cov]$ product-- 7,a7 means-- 7i7 any drug approv$ "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or biological product lic5s$ "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb72 7ii7 any comb9ation ( a drug or biological product describ$ 9 clause 7i72 or 7iii7 :5 reasonably necess>y to support approval ( an application "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 or section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb71 z applicable1 or o!rwise meet ! requirem5ts = approval "u ei!r su* section1 any product1 includ+ any device1 t is m>ket$ or int5d$ = use ) su* a drug or biological product2 & 7,b7 does n include any drug or biological product t appe>s on ! drug %ortage li/ 9 effect "u section #ejf;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e71 unless-- 7i7 ! drug or biological product has be5 on ! drug %ortage li/ 9 effect "u su* section #ejf;,e cont9u\sly = m ?an #f mon?s2 or 7ii7 ! ,secret>y det]m9es t inclusion ( ! drug or biological product z a cov]$ product is likely to contribute to alleviat+ or prev5t+ a %ortage2 7#c7 ! t]m device has ! mean+ giv5 ! t]m 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba72 7#d7 ! t]m eligible product develop] means a p]son t seeks to develop a product = approval pursuant to an application = approval "u subsection 7b77#b7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or = lic5s+ pursuant to an application "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k772 7#e7 ! t]m lic5se hold] means ! hold] ( an application approv$ "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or ! hold] ( a lic5se "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 = a cov]$ product2 7#f7 ! t]m ,,rems means a risk evaluation & mitigation /rategy "u section #eje-a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a72 7#g7 ! t]m ,,rems ) ,,etasu means a ,,rems t conta9s elem5ts to assure safe use "u section #eje-a7;f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;f772 7#h7 ! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices2 7#i7 ! t]m s+le1 %>$ sy/em ( elem5ts to assure safe use means a s+le1 %>$ sy/em ( elem5ts to assure safe use "u section #eje-a7;f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;f772 & 7#aj7 ! t]m suffici5t quantities means an am\nt ( a cov]$ product t ! eligible product develop] det]m9es all[s x to-- 7,a7 conduct te/+ to support an application "u-- 7i7 subsection 7b77#b7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee72 or 7ii7 section #cea7k7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k772 & 7,b7 fulfill any regulatory requirem5ts relat+ to approval ( su* an application4 7b7 ,civil action = failure ,to provide suffici5t quantities ( a cov]$ product 7#a7 ,9 g5]al ,an eligible product develop] may br+ a civil action aga9/ ! lic5se hold] = a cov]$ product seek+ relief "u ?is subsection 9 an appropriate di/rict c\rt ( ! ,unit$ ,/ates alleg+ t ! lic5se hold] has decl9$ to provide suffici5t quantities ( ! cov]$ product to ! eligible product develop] on comm]cially reasonable1 m>ket-bas$ t]ms4 7#b7 ,elem5ts 7,a7 ,9 g5]al ,to prevail 9 a civil action br\ght "u p>agraph 7#a71 an eligible product develop] %all prove1 by a prepond]ance ( ! evid5ce-- 7i7 t-- 7,i7 ! cov]$ product is n subject to a ,,rems ) ,,etasu2 or 7,,ii7 if ! cov]$ product is subject to a ,,rems ) ,,etasu-- 7aa7 ! eligible product develop] has obta9$ a cov]$ product au?orization f ! ,secret>y 9 accordance ) subp>agraph 7,b72 & 7bb7 ! eligible product develop] has provid$ a copy ( ! cov]$ product au?orization to ! lic5se hold]2 7ii7 t1 z ( ! date on :i* ! civil action is fil$1 ! product develop] has n obta9$ suffici5t quantities ( ! cov]$ product on comm]cially reasonable1 m>ket-bas$ t]ms2 7iii7 t ! eligible product develop] has reque/$ to pur*ase suffici5t quantities ( ! cov]$ product f ! lic5se hold]2 & 7iv7 t ! lic5se hold] has n deliv]$ to ! eligible product develop] suffici5t quantities ( ! cov]$ product on comm]cially reasonable1 m>ket-bas$ t]ms-- 7,i7 = a cov]$ product t is n subject to a ,,rems ) ,,etasu1 by ! date t is #ca days aft] ! date on :i* ! lic5se hold] receiv$ ! reque/ = ! cov]$ product2 & 7,,ii7 = a cov]$ product t is subject to a ,,rems ) ,,etasu1 by #ca days aft] ! lat] (-- 7aa7 ! date on :i* ! lic5se hold] receiv$ ! reque/ = ! cov]$ product2 or 7bb7 ! date on :i* ! lic5se hold] receiv$ a copy ( ! cov]$ product au?orization issu$ by ! ,secret>y 9 accordance ) subp>agraph 7,b74 7,b7 ,au?orization = cov]$ product subject to a ,,rems ) ,,etasu 7i7 ,reque/ ,an eligible product develop] may submit to ! ,secret>y a writt5 reque/ = ! eligible product develop] to be au?oriz$ to obta9 suffici5t quantities ( an individual cov]$ product subject to a ,,rems ) ,,etasu4 7ii7 ,au?orization ,n lat] ?an #abj days aft] ! date on :i* a reque/ "u clause 7i7 is receiv$1 ! ,secret>y %all1 by writt5 notice1 au?orize ! eligible product develop] to obta9 suffici5t quantities ( an individual cov]$ product subject to a ,,rems ) ,,etasu = purposes (-- 7,i7 developm5t & te/+ t does n involve human cl9ical trials1 if ! eligible product develop] has agre$ to comply ) any conditions ! ,secret>y det]m9es necess>y2 or 7,,ii7 developm5t & te/+ t involves human cl9ical trials1 if ! eligible product develop] has-- 7aa7 7,,aa7 submitt$ protocols1 in=m$ cons5t docum5ts1 & in=mational mat]ials = te/+ t include protections t provide safety protections comp>able to ^? provid$ by ! ,,rems = ! cov]$ product2 or 7,,bb7 o!rwise satisfi$ ! ,secret>y t su* protections w be provid$2 & 7bb7 met any o!r requirem5ts ! ,secret>y may e/abli%4 7iii7 ,notice ,a cov]$ product au?orization issu$ "u ?is subp>agraph %all /ate t ! provision ( ! cov]$ product by ! lic5se hold] "u ! t]ms ( ! au?orization w n be a violation ( ! ,,rems = ! cov]$ product4 7#c7 ,affirmative def5se ,9 a civil action br\ght "u p>agraph 7#a71 x %all be an affirmative def5se1 on :i* ! def5dant has ! burd5 ( p]suasion by a prepond]ance ( ! evid5ce-- 7,a7 t1 on ! date on :i* ! eligible product develop] reque/$ to pur*ase suffici5t quantities ( ! cov]$ product f ! lic5se hold]-- 7i7 nei!r ! lic5se hold] nor any ( its ag5ts1 :olesal]s1 or di/ributors 0 engag$ 9 ! manufactur+ or comm]cial m>ket+ ( ! cov]$ product2 & 7ii7 nei!r ! lic5se hold] nor any ( its ag5ts1 :olesal]s1 or di/ributors o!rwise _h access to inv5tory ( ! cov]$ product to supply to ! eligible product develop] on comm]cially reasonable1 m>ket-bas$ t]ms2 7,b7 t-- 7i7 ! lic5se hold] sells ! cov]$ product ?r\gh ag5ts1 di/ributors1 or :olesal]s2 7ii7 ! lic5se hold] has plac$ no re/rictions1 explicit or implicit1 on its ag5ts1 di/ributors1 or :olesal]s to sell cov]$ products to eligible product develop]s2 & 7iii7 ! cov]$ product c be pur*as$ by ! eligible product develop] 9 suffici5t quantities on comm]cially reasonable1 m>ket-bas$ t]ms f ! ag5ts1 di/ributors1 or :olesal]s ( ! lic5se hold]2 or 7,c7 t ! lic5se hold] made an (f] to sell suffici5t quantities ( ! cov]$ product to ! eligible product develop] at comm]cially reasonable m>ket-bas$ t]ms-- 7i7 = a cov]$ product t is n subject to a ,,rems ) ,,etasu1 by ! date t is #ad days aft] ! date on :i* ! lic5se hold] receiv$ ! reque/ = ! cov]$ product1 & ! eligible product develop] did n accept su* (f] by ! date t is #g days aft] ! date on :i* ! eligible product develop] receiv$ su* (f] f ! lic5se hold]2 or 7ii7 = a cov]$ product t is subject to a ,,rems ) ,,etasu1 by ! date t is #bj days aft] ! date on :i* ! lic5se hold] receiv$ ! reque/ = ! cov]$ product1 & ! eligible product develop] did n accept su* (f] by ! date t is #aj days aft] ! date on :i* ! eligible product develop] receiv$ su* (f] f ! lic5se hold]4 7#d7 ,me?ods = transmission ( reque/s = cov]$ products ,a writt5 reque/ = a cov]$ product1 (f] to sell a cov]$ product1 or acceptance ( su* an (f] betwe5 ! eligible product develop] & ! lic5se hold] %all be made by-- 7,a7 c]tifi$ or regi/]$ mail ) return receipt reque/$2 7,b7 p]sonal deliv]y2 or 7,c7 electronic means4 7#e7 ,rem$ies 7,a7 ,9 g5]al ,if an eligible product develop] prevails 9 a civil action br\ght "u p>agraph 7#a71 ! c\rt %all-- 7i7 ord] ! lic5se hold] to provide to ! eligible product develop] )\t delay suffici5t quantities ( ! cov]$ product on comm]cially reasonable1 m>ket-bas$ t]ms2 7ii7 aw>d to ! eligible product develop] reasonable attorney's fees & co/s ( ! civil action2 & 7iii7 aw>d to ! eligible product develop] a monet>y am\nt suffici5t to det] ! lic5se hold] f fail+ to provide eligible product develop]s ) suffici5t quantities ( a cov]$ product on comm]cially reasonable1 m>ket-bas$ t]ms1 if ! c\rt f9ds1 by a prepond]ance ( ! evid5ce-- 7,i7 t ! lic5se hold] delay$ provid+ suffici5t quantities ( ! cov]$ product to ! eligible product develop] )\t a legitimate bus9ess ju/ification2 or 7,,ii7 t ! lic5se hold] fail$ to comply ) an ord] issu$ "u clause 7i74 7,b7 ,maximum monet>y am\nt ,a monet>y am\nt aw>d$ "u subp>agraph 7,a77iii7 %all n be great] ?an ! rev5ue t ! lic5se hold] e>n$ on ! cov]$ product dur+ ! p]iod-- 7i7 beg9n+ on-- 7,i7 = a cov]$ product t is n subject to a ,,rems ) ,,etasu1 ! date t is #ca days aft] ! date on :i* ! lic5se hold] receiv$ ! reque/2 or 7,,ii7 = a cov]$ product t is subject to a ,,rems ) ,,etasu1 ! date t is #ca days aft] ! lat] (-- 7aa7 ! date on :i* ! lic5se hold] receiv$ ! reque/2 or 7bb7 ! date on :i* ! lic5se hold] receiv$ a copy ( ! cov]$ product au?orization issu$ by ! ,secret>y 9 accordance ) p>agraph 7#b77;,b72 & 7ii7 end+ on ! date on :i* ! eligible product develop] receiv$ suffici5t quantities ( ! cov]$ product4 7,c7 ,avoidance ( delay ,! c\rt may issue an ord] "u subp>agraph 7,a77i7 be=e conduct+ fur!r proce$+s t may be necess>y to det]m9e :e!r ! eligible product develop] is entitl$ to an aw>d "u clause 7ii7 or 7iii7 ( subp>agraph 7,a71 or ! am\nt ( any su* aw>d4 7c7 ,limitation ( liability ,a lic5se hold] = a cov]$ product %all n be liable = any claim "u ,f$]al1 ,/ate1 or local law aris+ out ( ! failure ( an eligible product develop] to foll[ adequate safegu>ds to assure safe use ( ! cov]$ product dur+ developm5t or te/+ activities describ$ 9 ?is section1 includ+ transportation1 h&l+1 use1 or disposal ( ! cov]$ product by ! eligible product develop]4 7d7 ,no violation ( ,,rems ,section #eje-a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7l7 ,provision ( samples n a violation ( /rategy ,! provision ( samples ( a cov]$ product to an eligible product develop] 7z ^? t]ms are def9$ 9 section #b7;a7 ( ! ,creat+ & ,re/or+ ,equal ,access to ,equival5t ,samples ,act ( #bjai7 %all n be consid]$ a violation ( ! requirem5ts ( any risk evaluation & mitigation /rategy t may be 9 place "u ?is section = su* drug4 4 7e7 ,rule ( con/ruction 7#a7 ,def9ition ,9 ?is subsection1 ! t]m antitru/ laws-- 7,a7 has ! mean+ giv5 ! t]m 9 subsection 7a7 ( ! fir/ section ( ! ,clayton ,act 7#ae ,u4,s4,c4 #ab72 & 7,b7 includes section #e ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to ! ext5t t su* section applies to unfair me?ods ( competition4 7#b7 ,antitru/ laws ,no?+ 9 ?is section %all be con/ru$ to limit ! op]ation ( any provision ( ! antitru/ laws4 #ajb4 ,,rems approval process = subsequ5t fil]s ,section #eje-a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a71 z am5d$ by section #aja1 is fur!r am5d$-- 7#a7 9 subsection 7g77#d77;,b7-- 7,a7 9 clause 7i7 by /rik+ or aft] ! semicolon2 7,b7 9 clause 7ii7 by /rik+ ! p]iod at ! end & ins]t+ 2 or2 & 7,c7 by add+ at ! end ! foll[+3 7iii7 accommodate diff]5t1 comp>able aspects ( ! elem5ts to assure safe use = a drug t is ! subject ( an application "u section #eje7;j71 & ! applicable li/$ drug4 2 7#b7 9 subsection 7i77#a71 by /rik+ subp>agraph 7,c7 & ins]t+ ! foll[+3 7,c7 7i7 ,elem5ts to assure safe use1 if requir$ "u subsection 7f7 = ! li/$ drug1 :i*1 subject to clause 7ii71 = a drug t is ! subject ( an application "u section #eje7;j7 may use-- 7,i7 a s+le1 %>$ sy/em ) ! li/$ drug "u subsection 7f72 or 7,,ii7 a diff]5t1 comp>able aspect ( ! elem5ts to assure safe use "u subsection 7f74 7ii7 ,! ,secret>y may require a drug t is ! subject ( an application "u section #eje7;j7 & ! li/$ drug to use a s+le1 %>$ sy/em "u subsection 7f71 if ! ,secret>y det]m9es t no diff]5t1 comp>able aspect ( ! elem5ts to assure safe use c\ld satisfy ! requirem5ts ( subsection 7f74 2 7#c7 9 subsection 7i71 by add+ at ! end ! foll[+3 7#c7 ,%>$ ,,rems ,if ! ,secret>y approves1 9 accordance ) p>agraph 7#a77;,c77i77,,ii71 a diff]5t1 comp>able aspect ( ! elem5ts to assure safe use "u subsection 7f7 = a drug t is ! subject ( an abbreviat$ new drug application "u section #eje7;j71 ! ,secret>y may require t su* diff]5t comp>able aspect ( ! elem5ts to assure safe use c be us$ ) respect to any o!r drug t is ! subject ( an application "u section #eje7;j7 or #eje7;b7 t ref]5ces ! same li/$ drug4 2 & 7#d7 by add+ at ! end ! foll[+3 7m7 ,sep>ate ,,rems ,:5 us$ 9 ?is section1 ! t]ms diff]5t1 comp>able aspect ( ! elem5ts to assure safe use or diff]5t1 comp>able approv$ risk evaluation & mitigation /rategies means a risk evaluation & mitigation /rategy = a drug t is ! subject ( an application "u section #eje7;j7 t uses diff]5t me?ods or op]ational means ?an ! /rategy requir$ "u subsection 7a7 = ! applicable li/$ drug1 or o!r application "u section #eje7;j7 ) ! same su* li/$ drug1 b a*ieves ! same level ( safety z su* /rategy4 4 ,,ii ,,increas+ ,,access ,,to ,,drugs ,,& ,,biosimil> ,,products #bja4 ,exp$it$ developm5t & priority review = g5]ic complex drug products ,sub*apt] ,a ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by add+ at ! end ! foll[+3 #ebd;,b4 ,exp$it$ developm5t & priority review = g5]ic complex drug products 7a7 ,e/abli%m5t ( program ,! ,secret>y %all e/abli% a program to exp$ite ! developm5t (1 & provide priority review "u section #eje7;j7 =1 g5]ic complex drug products4 7b7 ,reque/ = designation ,a sponsor ( a g5]ic complex drug product may reque/ t ! ,secret>y designate su* product = exp$it$ developm5t & priority review "u ?is section4 7c7 ,designation process 7#a7 ,9 g5]al ,n lat] ?an #fj cal5d> days aft] ! receipt ( a reque/ "u subsection 7c71 ! ,secret>y %all det]m9e :e!r ! product t is ! subject ( ! reque/ meets ! crit]ia "u subsection 7e7 to be consid]$ a g5]ic complex drug product4 ,if ! ,secret>y det]m9es t ! product meets ! crit]ia1 ! ,secret>y %all designate ! product = exp$it$ developm5t & priority review4 7#b7 ,review ,review ( a reque/ "u subsection 7b7 %all be und]tak5 by a team t is compos$ ( exp]i5c$ /aff & s5ior manag]s ( ! ,food & ,drug ,adm9i/ration4 7#c7 ,)drawal ,! ,secret>y may n )draw a designation grant$ "u ?is section on ! basis ( ! crit]ia "u subsection 7e7 no long] apply+ because ( ! subsequ5t cle>ance or approval ( any o!r product4 7d7 ,exp$it$ developm5t & priority review ,guidance 7#a7 ,cont5t ,n lat] ?an ,decemb] #ca1 #bjba1 ! ,secret>y %all issue guidance on ! implem5tation ( ?is section4 ,su* guidance %all-- 7,a7 set =? ! process by :i* a p]son may seek a designation "u subsection 7c72 7,b7 provide a template = reque/s "u subsection 7b72 7,c7 id5tify ! crit]ia ! ,secret>y w use 9 evaluat+ a reque/ = designation "u ?is section2 & 7,d7 id5tify ! crit]ia & processes ! ,secret>y w use to exp$ite ! developm5t & review ( products designat$ "u ?is section4 7#b7 ,process ,prior to f9aliz+ ! guidance "u p>agraph 7#a71 ! ,secret>y %all seek public comm5t on a draft v]sion ( t guidance4 7e7 ,g5]ic complex drug product def9$ ,9 ?is section1 ! t]m g5]ic complex drug product means a product t repres5ts a complex !rapy t consi/s ( or includes a drug = approval "u section #eje7;j7 & t-- 7#a7 7,a7 conta9s complex active +r$i5ts 7su* z peptides1 polym]ic comp\nds1 complex mixtures ( active +r$i5ts1 & naturally s\rc$ +r$i5ts72 7,b7 is compos$ ( complex =mulations 7su* z liposomes or colloids72 7,c7 requires a complex r\te ( deliv]y 7su* z locally act+ drugs su* z d]matological products & complex oph?almological products & otic dosage =ms t are =mulat$ z susp5sions1 emulsions1 or gels72 or 7,d7 involves a complex dosage =m 7su* z transd]mals1 met]$ dose inhal]s1 or ext5d$ release injectables72 7#b7 pres5ts z a complex drug-device comb9ation product 7su* z auto injectors or met]$ dose inhal]s72 or 7#c7 is a product t w\ld b5efit f e>ly sci5tific engagem5t due to complexity or unc]ta9ty conc]n+ ! approval pa?way "u section #eje7;j74 4 #bjb4 ,increas+ ph>maceutical options to treat an unmet m$ical ne$ ,subsection 7b7 ( section #ejf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 is am5d$ by add+ at ! end ! foll[+3 7#d7 ,unmet m$ical ne$ ,= purposes ( p>agraph 7#a71 a drug %all be deem$ to address an unmet m$ical ne$ = a disease or condition if few] ?an #c available drugs exi/ = ! treatm5t ( su* disease or condition4 4 #bjc4 ,preemption ( ,/ate b>ri]s to ! sub/itution ( biosimil> products ,no ,/ate1 or any political subdivision !re(1 may prohibit a ph>macy or ph>maci/ f disp5s+1 9 place ( a biological ref]5ce product1 any product t1 pursuant to section #cea7k7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k771 has be5 det]m9$ by ! ,secret>y ( ,heal? & ,human ,s]vices to be int]*angeable ) ! ref]5ce product 9 accordance ) subsections 7a7 & 7k77#d7 ( su* ,act 7#db ,u4,s4,c4 #bfb7;a71 7k77#d774 #bjd4 ,exp$it$ process = biological products au?oriz$ = m>ket+ 9 ,european ,union ,section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#d7 ,products au?oriz$ = m>ket+ 9 ,european ,union ,9 consid]+ :e!r to lic5se a biological product "u ?is subsection or subsection 7k71 ! ,secret>y may exp$ite ! lic5s+ process if ! biological product has be5 au?oriz$ = m>ket+ by ! ,european ,m$ic9es ,ag5cy & su* au?orization rema9s 9 effect4 4 ,,iii ,,prescription ,,drug ,,pric+ ,,& ,,competition #cja4 ,m$ic>e drug cov]age ,not)/&+ any o!r provision ( law1 ! ,secret>y ( ,heal? & ,human ,s]vices may alt] paym5ts = prescription drugs1 includ+ biologicals1 provid$ ?r\gh ! ,m$ic>e "p ,b program by pay+ at rates t1 bas$ on ! av]age sales price plus #f p]c5t 9 ! ye> ( implem5tation ( ?is ,act1 gr[ at ! consum] price index 7,,cpi ,prescription ,drugs74 #cjb4 ,fee transp>5cy betwe5 ph>macies & ,p,b,ms 7a7 ,prohibit+ m$ic>e ,,pdp sponsors & ,,ma-,,pd organizations f retroactively r$uc+ paym5t on clean claims submitt$ by ph>macies 7#a7 ,9 g5]al ,section #ahfj;,d-#ab7;b77#d77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77#d77;,a77 is am5d$ by add+ at ! end ! foll[+ new clause3 7iv7 ,prohibit+ retroactive r$uctions 9 paym5ts on clean claims ,ea* contract ent]$ into ) a ,,pdp sponsor "u ?is "p ) respect to a prescription drug plan (f]$ by su* sponsor %all provide t aft] ! date ( receipt ( a clean claim submitt$ by a ph>macy1 ! ,,pdp sponsor 7or an ag5t ( ! ,,pdp sponsor7 may n retroactively r$uce paym5t on su* claim directly or indirectly ?r\gh aggregat$ effective rate or o!rwise except 9 ! case su* claim is f\nd to n be a clean claim 7su* z 9 ! case ( a claim lack+ requir$ sub/antiat+ docum5tation7 dur+ ! c\rse ( a r\t9e audit z p]mitt$ pursuant to writt5 agreem5t betwe5 ! ,,pdp sponsor 7or su* an ag5t7 & su* ph>macy4 ,! previ\s s5t5ce %all n prohibit any retroactive increase 9 paym5t to a ph>macy pursuant to a writt5 agreem5t betwe5 a ,,pdp sponsor 7or an ag5t ( su* sponsor7 & su* ph>macy4 4 7#b7 ,effective date ,! am5dm5t made by subsection 7a7 %all apply ) respect to contracts ent]$ into on or aft] ,janu>y #a1 #bjba4 7b7 ,elim9ation ( ,,dir fees 7#a7 ,ph>macy b5efits manag] /&>ds "u ! ,m$ic>e program = prescription drug plans & ,,ma-,,pd plans 7,a7 ,9 g5]al ,section #ahfj;,d-#ab7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#g7 ,ph>macy b5efits manag] transp>5cy requirem5ts ,ea* contract ent]$ into ) a ,,pdp sponsor "u ?is "p ) respect to a prescription drug plan (f]$ by su* sponsor or ) an ,,ma organization (f]+ an ,,ma-,,pd plan "u "p ,c %all provide t ! sponsor or organization1 respectively1 may n ent] into a contract ) any ph>macy b5efits manag] 7ref]r$ to 9 ?is p>agraph z a ,,pbm7 to manage ! prescription drug cov]age provid$ "u su* plan1 or to control ! co/s ( ! prescription drug cov]age "u su* plan1 unless ! ,,pbm adh]es to ! foll[+ crit]ia :5 h&l+ p]sonally id5tifiable utilization & claims data or o!r s5sitive pati5t data3 7,a7 ,! ,,pbm may n transmit any p]sonally id5tifiable utilization1 protect$ heal? in=mation1 or claims data1 ) respect to a plan enrollee1 to a ph>macy own$ by a ,,pbm if ! plan enrollee has n volunt>ily elect$ 9 writ+ or via secure electronic means to fill t p>ticul> prescription at ! ,,pbm-own$ ph>macy4 7,b7 ,! ,,pbm may n require t a plan enrollee use a retail ph>macy1 mail ord] ph>macy1 specialty ph>macy1 or o!r ph>macy entity provid+ ph>macy s]vices 9 :i* ! ,,pbm has an own]%ip int]e/ or t has an own]%ip int]e/ 9 ! ,,pbm1 or provide an inc5tive to a plan enrollee to enc\rage ! enrollee to use a retail ph>macy1 mail ord] ph>macy1 specialty ph>macy1 or o!r ph>macy entity provid+ ph>macy s]vices 9 :i* ! ,,pbm has an own]%ip int]e/ or t has an own]%ip int]e/ 9 ! ,,pbm1 if ! inc5tive is applicable only to su* ph>macies4 4 7,b7 ,regul> update ( prescription drug pric+ /&>d ,p>agraph 7#f7 ( section #ahfj;,d-#ab7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77 is am5d$ to read z foll[s3 7#f7 ,regul> update ( prescription drug pric+ /&>d 7,a7 ,9 g5]al ,if ! ,,pdp sponsor ( a prescription drug plan 7or ,,ma organization (f]+ an ,,ma-,,pd plan7 uses a /&>d = reimbursem5t 7z describ$ 9 subp>agraph 7,b77 ( ph>macies bas$ on ! co/ ( a drug1 ea* contract ent]$ into ) su* sponsor "u ?is "p 7or organization "u "p ,c7 ) respect to ! plan %all provide t ! sponsor 7or organization7 %all-- 7i7 update su* /&>d n less frequ5tly ?an once e #g days1 beg9n+ ) an initial update on ,janu>y #a ( ea* ye>1 to accurately reflect ! m>ket price ( acquir+ ! drug2 7ii7 disclose to applicable ph>macies & ! contract+ entities ( su* ph>macies ! s\rces us$ = mak+ any su* update imm$iately )\t requirem5t ( reque/2 7iii7 if ! s\rce = su* a /&>d = reimbursem5t is n publicly available1 disclose to ! applicable ph>macies & ! respective contract+ entities ( su* ph>macies all individual drug prices to be s updat$ 9 advance ( ! use ( su* prices = ! reimbursem5t ( claims2 7iv7 e/abli% a process to appeal1 inve/igate1 & resolve disputes reg>d+ individual drug prices t are less ?an ! ph>macy acquisition price = su* drug1 :i* mu/ be adjudicat$ )9 #g days ( ! ph>macy fil+ its appeal2 & 7v7 provide all su* pric+ data 9 an 4xml spread%eet =mat or a comp>able easily accessible & complete spread%eet =mat4 7,b7 ,prescription drug pric+ /&>d def9$ ,= purposes ( subp>agraph 7,a71 a /&>d = reimbursem5t ( a ph>macy is any me?odology or =mula = v>y+ ! pric+ ( a drug or drugs dur+ ! t]m ( ! ph>macy reimbursem5t contract t is bas$ on ! co/ ( ! drug involv$1 includ+ drug pric+ ref]5ces & am\nts t are bas$ ^u av]age :olesale price1 :olesale av]age co/1 av]age manufactur] price1 av]age sales price1 maximum all[able co/ 7,,mac71 or o!r co/s1 :e!r publicly available or n4 4 7,c7 ,effective date ,! am5dm5ts made by ?is section %all apply to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbj4 7#b7 ,regul> update ( prescription drug pric+ /&>d "u ,,tric>e retail ph>macy program ,section #ajgd;g7d7 ( title #aj1 ,unit$ ,/ates ,code1 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#c7 ,to ! ext5t practicable1 ) respect to ! ,,tric>e retail ph>macy program describ$ 9 subsection 7a77#b77;,e77ii71 ! ,secret>y %all ensure t a contract ent]$ into ) a ,,tric>e manag$ c>e support contractor includes requirem5ts describ$ 9 section #ahfj;,d-#ab7;b77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77#f77 to ensure ! provision ( in=mation reg>d+ ! pric+ /&>d = prescription drugs4 4 7#c7 ,prescription drug transp>5cy 9 ! ,f$]al ,employees ,heal? ,b5efits program 7,a7 ,9 g5]al ,section #hijb ( title #e1 ,unit$ ,/ates ,code1 is am5d$ by add+ at ! end ! foll[+ new subsections3 7p7 ,a contract may n be made or a plan approv$ "u ?is *apt] "u :i* a c>ri] has an agreem5t ) a ph>macy b5efits manag] 79 ?is subsection ref]r$ to z a ,,pbm7 to manage prescription drug cov]age or to control ! co/s ( ! prescription drug cov]age unless ! c>ri] & ,,pbm adh]e to ! foll[+ crit]ia3 7#a7 ,! ,,pbm may n transmit any p]sonally id5tifiable utilization1 protect$ heal? in=mation1 or claims data ) respect to an individual enroll$ "u su* contract or plan to a ph>macy own$ by ! ,,pbm if ! individual has n volunt>ily elect$ 9 writ+ or via secure electronic means to fill t p>ticul> prescription at su* a ph>macy4 7#b7 ,! ,,pbm may n require t an individual enroll$ "u su* contract or plan use a retail ph>macy1 mail ord] ph>macy1 specialty ph>macy1 or o!r ph>macy entity provid+ ph>macy s]vices 9 :i* ! ,,pbm has an own]%ip int]e/ or t has an own]%ip int]e/ 9 ! ,,pbm or provide an inc5tive to a plan enrollee to enc\rage ! enrollee to use a retail ph>macy1 mail ord] ph>macy1 specialty ph>macy1 or o!r ph>macy entity provid+ ph>macy s]vices 9 :i* ! ,,pbm has an own]%ip int]e/ or t has an own]%ip int]e/ 9 ! ,,pbm1 if ! inc5tive is applicable only to su* ph>macies4 7q7 7#a7 ,if a contract made or plan approv$ "u ?is *apt] provides = a /&>d = reimbursem5t 7z describ$ 9 p>agraph 7#b77 ) respect to a prescription drug plan1 su* contract or plan %all provide t ! applicable c>ri]-- 7,a7 update su* /&>d n less frequ5tly ?an once e #g days1 beg9n+ ) an initial update on ,janu>y #a ( ea* ye>1 to accurately reflect ! m>ket price ( acquir+ ! drug2 7,b7 disclose to applicable ph>macies & ! contract+ entities ( su* ph>macies ! s\rces us$ = mak+ any su* update imm$iately )\t requirem5t ( reque/2 7,c7 if ! s\rce = su* a /&>d = reimbursem5t is n publicly available1 disclose to ! applicable ph>macies & contract+ entities ( su* ph>macies all individual drug prices to be s updat$ 9 advance ( ! use ( su* prices = ! reimbursem5t ( claims2 7,d7 e/abli% a process to appeal1 inve/igate1 & resolve disputes reg>d+ individual drug prices t are less ?an ! ph>macy acquisition price = su* drug1 :i* mu/ be adjudicat$ )9 #g days ( ! ph>macy fil+ its appeal2 & 7,e7 provide all su* pric+ data 9 an 4xml spread%eet =mat or a comp>able easily accessible & complete spread%eet =mat4 7#b7 ,= purposes ( p>agraph 7#a71 a /&>d = reimbursem5t ( a ph>macy is any me?odology or =mula = v>y+ ! pric+ ( a drug or drugs dur+ ! t]m ( ! ph>macy reimbursem5t contract t is bas$ on ! co/ ( ! drug involv$1 includ+ drug pric+ ref]5ces & am\nts t are bas$ ^u av]age :olesale price1 :olesale av]age co/1 av]age manufactur] price1 av]age sales price1 maximum all[able co/1 or o!r co/s1 :e!r publicly available or n4 4 7,b7 ,application ,! am5dm5t made by subp>agraph 7,a7 %all apply to any contract ent]$ into "u section #hijb ( title #e1 ,unit$ ,/ates ,code1 on or aft] ! date ( enactm5t ( ?is section4 #cjc4 ,sunset ( limit on maximum rebate am\nt = s+le s\rce drugs & innovator multiple s\rce drugs ,section #aibg7;c77#b77;,d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#b77;,d77 is am5d$ by ins]t+ aft] ,decemb] #ca1 #bjji1 ! foll[+3 & be=e ,decemb] #ca1 #bjbd14 #cjd4 ,regulation ( manufactur]-sponsor$ copay contributions ,not)/&+ any o!r provision ( law1 ! ,secret>y ( ,heal? & ,human ,s]vices may e/abli% a me*anism prohibit+ drug manufactur]s f contribut+ f9ancially to pati5t copays1 & e/abli% a sy/em ( p5aliz+ su* behavior4 ,,iv ,,pat5t ,,disclosure ,,requirem5ts #dja4 ,pat5t disclosure & transp>5cy requirem5ts 7a7 ,9 g5]al 7#a7 ,9 g5]al ,section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 is am5d$ by add+ at ! end ! foll[+3 7o7 ,additional requirem5ts ) respect to pat5ts 7#a7 ,publication ( in=mation 7,a7 ,9 g5]al ,)9 #a ye> ( ! date ( enactm5t ( ! ,biologic ,pat5t ,transp>5cy ,act1 ! ,secret>y %all publi% & make available to ! public a s+le1 easily se>*able li/ t includes-- 7i7 ! prop] & propriet>y "n ( ea* biological product lic5s$ or deem$ to be lic5s$ "u subsection 7a7 or 7k72 7ii7 ! date ( approval & application numb] = ea* su* biological product2 7iii7 ! m>ket+ /atus1 dosage =m1 r\te ( adm9i/ration1 /r5g?1 &1 if applicable1 ref]5ce product1 = ea* su* biological product2 7iv7 ! lic5sure /atus = ea* su* biological product1 includ+ :e!r ! lic5se at ! "t ( li/+ is approv$1 )drawn1 or revok$2 7v7 = ea* su* biological product t is a ref]5ce product = :i* an exclusivity p]iod applies1 & = :i* ! ,secret>y has det]m9$ ! dates ( su* exclusivity p]iod1 "u subsection 7k77#g77;,a7 or subsection 7k77#g77;,b7 ( ?is section or "u section #ebg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 includ+ any ext5sion ( su* exclusivity p]iod 9 accordance ) subsection 7m7 ( ?is section1 ! date on :i* su* exclusivity p]iod expires2 7vi7 any det]m9ation ( biosimil>ity or int]*angeability = ea* su* biological product2 & 7vii7 in=mation reg>d+ approv$ indications = ea* su* biological product1 9 su* mann] z ! ,secret>y det]m9es appropriate4 7,b7 ,updates ,e #cj days aft] ! publication ( ! fir/ li/ "u subp>agraph 7,a71 ! ,secret>y %all revise ! li/ to include-- 7i7 7,i7 ea* biological product lic5s$ "u subsection 7a7 or 7k7 dur+ ! #cj-;day p]iod2 & 7,,ii7 ) respect to ea* biological product describ$ 9 subclause 7,i71 ! in=mation describ$ 9 clauses 7i7 ?r\gh 7vii7 ( subp>agraph 7,a72 & 7ii7 any updates to in=mation previ\sly publi%$ 9 accordance ) subp>agraph 7,a74 4 7#b7 ,public li/+ ( pat5t in=mation 7,a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %all include 9 ! recomm5dations transmitt$ to ,congress "u section #gdd;,i7f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7;f77 recomm5dations ) respect to ! collection & publication ( pat5t in=mation 9 ! li/ describ$ 9 section #cea7o7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb71 z add$ by p>agraph 7#a74 7,b7 ,developm5t ,9 develop+ recomm5dations "u subp>agraph 7,a71 ! ,secret>y ( ,heal? & ,human ,s]vices may consult ) ! ,f$]al ,trade ,commission1 ! ,director ( ! ,unit$ ,/ates ,pat5t & ,tradem>k ,(fice1 & ! ,f$]al ,trade ,commission1 9 addition to ! entities li/$ 9 section #gdd;,i7f77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7;f77#a774 7b7 ,rule ( con/ruction ,no?+ 9 ?is section1 includ+ ! am5dm5t made by ?is section1 %all be con/ru$ to require or all[ ! ,secret>y ( ,heal? & ,human ,s]vices to delay ! review or approval ( a biologic lic5se application "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 #djb4 ,antitru/ exemption = heal? insurance issu]s ,to negotiate :olesale acquisition prices ( prescription drugs pur*as$ f drug manufactur]s 7a7 ,exemption ,x %all n be a violation ( ! antitru/ laws = "o or m heal? insurance issu]s or _! designat$ ag5ts to jo9tly negotiate :olesale acquisition prices ( a prescription drug ) a manufactur] ( a prescription drug ) reg>ds to ! reimbursem5t policies ( ! insur]s ( ! manufactur]'s drugs s long z no s+le :olesale acquisition price is jo9tly det]m9$ betwe5 ! insurance issu]s or _! designat$ ag5ts4 7b7 ,def9itions ,= purposes ( ?is section3 7#a7 ,antitru/ laws ,! t]m antitru/ laws has ! mean+ giv5 x 9 subsection 7a7 ( ! #a/ section ( ! ,clayton ,act 7#ae ,u4,s4,c4 #ab7;a771 except t su* t]m includes section #e ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to ! ext5t su* section #e applies to unfair me?ods ( competition4 7#b7 ,heal? insurance issu] ,! t]m heal? insurance issu] has ! mean+ giv5 t t]m 9 section #bgia7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ia7;b774 7#c7 ,heal? ma9t5ance organization ,! t]m heal? ma9t5ance organization means-- 7,a7 a f$]ally qualifi$ heal? ma9t5ance organization 7z def9$ 9 section #cjj;e7a7 ( title #db ( ! ,code ( ,f$]al ,regulations71 7,b7 an organization recogniz$ "u ,/ate law z a heal? ma9t5ance organization1 or 7,c7 a simil> organization regulat$ "u ,/ate law = solv5cy 9 ! same mann] & to ! same ext5t z su* a heal? ma9t5ance organization4 7#d7 ,manufactur] ,! t]m manufactur] means anyone :o is engag$ 9 manufactur+1 prep>+1 propagat+1 comp\nd+1 process+1 packag+1 repackag+1 or label+ ( a prescription drug4 7#e7 ,prescription drug ,! t]m prescription drug means a drug = human use subject to section #ejc7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;b77#a774 7c7 ,effective date ,?is section %all take effect on ! date ( ! enactm5t ( ?is ,act b %all n apply ) respect to conduct t occurs be=e su* date4 #djc4 ,fair treatm5t ( ,m$ic>e "p ,b bill+ codes = ! prescrib+ ( biosimil>s ,section #ahdg;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7h7 ,use ( c]ta9 codes ,not)/&+ any previ\s provision ( ?is section1 = purposes ( paym5t ( biological biosimil> product ! ,secret>y ( ,heal? & ,human ,s]vices %all assign a uni=m ,common ,proc$ure ,sy/em code to describe all su* products t %>e a common ref]5ce product4 4 ,v ,,fix+ ,,global ,,freeload+ #eja4 ,*ief ,ph>maceutical ,negotiator 9 ! ,(fice ( ! ,unit$ ,/ates ,trade ,repres5tative 7a7 ,9 g5]al ,section #ada ( ! ,trade ,act ( #aigd 7#ai ,u4,s4,c4 #baga7 is am5d$-- 7#a7 9 subsection 7b77#b7-- 7,a7 by /rik+ & "o ,*ief ,innovation & ,intellectual ,prop]ty ,negotiator & ins]t+ "o ,*ief ,innovation & ,intellectual ,prop]ty ,negotiator1 & "o ,*ief ,ph>maceutical ,negotiator2 7,b7 by /rik+ or ! ,*ief ,innovation & ,intellectual ,prop]ty ,negotiator & ins]t+ ! ,*ief ,innovation & ,intellectual ,prop]ty ,negotiator1 or ! ,*ief ,ph>maceutical ,negotiator2 & 7,c7 by /rik+ & ! ,*ief ,innovation & ,intellectual ,prop]ty ,negotiator & ins]t+ ! ,*ief ,innovation & ,intellectual ,prop]ty ,negotiator1 & ! ,*ief ,ph>maceutical ,negotiator2 & 7#b7 9 subsection 7c71 by add+ at ! end ! foll[+ new p>agraph3 7#g7 ,! pr9cipal function ( ! ,*ief ,ph>maceutical ,negotiator %all be to conduct trade negotiations & to en=ce trade agreem5ts relat+ to ,unit$ ,/ates ph>maceutical products & s]vices4 ,! ,*ief ,ph>maceutical ,negotiator %all be a vigor\s advocate on behalf ( ,unit$ ,/ates ph>maceutical int]e/s1 includ+ pati5ts & ,unit$ ,/ates ph>maceutical work]s4 ,! ,*ief ,ph>maceutical ,negotiator %all p]=m su* o!r functions z ! ,unit$ ,/ates ,trade ,repres5tative may direct4 4 7b7 ,comp5sation ,section #ecad ( title #e1 ,unit$ ,/ates ,code is am5d$ by /rik+ ,*ief ,innovation & ,intellectual ,prop]ty ,negotiator1 ,(fice ( ! ,unit$ ,/ates ,trade ,repres5tative4 & ins]t+ ! foll[+3 ,*ief ,innovation & ,intellectual ,prop]ty ,negotiator1 ,(fice ( ! ,unit$ ,/ates ,trade ,repres5tative4 ,*ief ,ph>maceutical ,negotiator1 ,(fice ( ! ,unit$ ,/ates ,trade ,repres5tative4 4 7c7 ,report requir$ ,n lat] ?an "o ye> aft] ! appo9tm5t ( ! fir/ ,*ief ,ph>maceutical ,negotiator pursuant to p>agraph 7#b7 ( section #ada7;b7 ( ! ,trade ,act ( #aigd1 z am5d$ by subsection 7a71 & annually !reaft]1 ! ,unit$ ,/ates ,trade ,repres5tative %all submit to ! ,committee on ,f9ance ( ! ,s5ate & ! ,committee on ,ways & ,means ( ! ,h\se ( ,repres5tatives a report describ+ 9 detail-- 7#a7 en=cem5t actions tak5 by ! ,trade ,repres5tative dur+ ! "o-ye> p]iod prec$+ ! submission ( ! report to ensure ! protection ( ,unit$ ,/ates ph>maceutical products & s]vices2 & 7#b7 o!r actions tak5 by ! ,trade ,repres5tative to advance ,unit$ ,/ates ph>maceutical products & s]vices4