,i #aah? ,,congress #a/ ,session ,h4 ,r4 #ffjg ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,decemb] #e1 #bjbc,ms4 ,s*ak[sky 7= h]self1 ,ms4 ,lee ( ,cali=nia1 ,mr4 ,jackson ( ,ill9ois1 ,ms4 ,norton1 ,ms4 ,jayapal1 ,mrs4 ,*]filus-,mc,cormick1 ,mr4 ,davis ( ,ill9ois1 ,mr4 ,g>ca ( ,ill9ois1 & ,mr4 ,grijalva7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,public ,heal? ,s]vice ,act to e/abli% an ,(fice ( ,drug ,manufactur+4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,af=dable ,drug ,manufactur+ ,act ( #bjbc4 #b4 ,public manufactur+ ( ph>maceuticals ,"p ,a ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda et seq47 is am5d$ by add+ at ! end ! foll[+3 #caj;,c4 ,manufactur+ ( drugs 7a7 ,e/abli%m5t ( ,(fice ( ,drug ,manufactur+ 7#a7 ,9 g5]al ,!re is e/abli%$ )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices an (fice to be kn[n z ! ,(fice ( ,drug ,manufactur+ 7ref]r$ to 9 ?is section z ! ,(fice74 7#b7 ,purpose ,! purpose ( ! ,(fice is-- 7,a7 to increase competition1 l[] prices1 & address %ortages 9 ! m>ket = prescription drugs1 includ+ insul91 a/hma & *ronic ob/ructive pulmon>y disease 7,,copd7 inhal]s1 naloxone1 ep9ephr9e auto-injectors1 & antibiotics2 7,b7 to r$uce ! co/ ( prescription drugs to ,f$]al & ,/ate heal? programs1 taxpay]s1 & consum]s2 & 7,c7 to increase pati5t access to af=dable drugs & associat$ devices4 7#c7 ,p]sonnel 7,a7 ,director 7i7 ,9 g5]al ,! ,(fice %all be head$ by a ,director1 :o %all be appo9t$ by ! ,presid5t4 7ii7 ,comp5sation ,! ,director %all be comp5sat$ at ! rate prescrib$ = level ,,iii ( ! ,executive ,s*$ule4 7,b7 ,employees ,! ,director ( ! ,(fice1 9 consultation ) ! ,secret>y1 may fix ! numb] (1 & appo9t & direct1 all employees ( ! ,(fice4 7,c7 ,bann$ individuals 7i7 ,drug company lobbyi/s ,no =m] regi/]$ drug indu/ry lobbyi/-- 7,i7 may be appo9t$ to ! position ( ,director ( ! ,(fice2 or 7,,ii7 may be employ$ by ! ,(fice dur+ ! #f-ye> p]iod beg9n+ on ! date on :i* ! regi/]$ lobbyi/ t]m9ates its regi/ration 9 accordance ) section #d7;d7 ( ! ,lobby+ ,disclosure ,act ( #aiie 7#b ,u4,s4,c4 #afjc7;d77 or ! ag5t t]m9ates its /atus1 z applicable4 7ii7 ,s5ior executives ( law-break+ companies ,no =m] s5ior executive ( a cov]$ entity 7z def9$ 9 clause 7iii77 :o 0 employ$ by su* entity on any date on :i* wrongful conduct is ! subject ( a settlem5t1 decree or en=cem5t action describ$ 9 clause 7iii77,,iii7 occurr$-- 7,i7 may be appo9t$ to ! position ( ,director ( ! ,(fice2 or 7,,ii7 may be employ$ by ! ,(fice dur+ ! #f-ye> p]iod beg9n+ on ! lat] (-- 7aa7 ! date ( ! settlem5t2 & 7bb7 ! date on :i* ! en=cem5t action has conclud$4 7iii7 ,cov]$ entity ,! t]m cov]$ entity means any entity t is curr5tly-- 7,i7 a drug manufactur]2 7,,ii7 a :olesal]2 & 7,,iii7 7aa7 op]at+ "u ,f$]al settlem5t1 includ+ a ,f$]al cons5t decree2 or 7bb7 ! subject ( an en=cem5t action 9 a c\rt ( ! ,unit$ ,/ates or by an ag5cy4 7#d7 ,duties 7,a7 ,9 g5]al ,! ,(fice %all-- 7i7 prep>e & submit applications = approval to ! ,food & ,drug ,adm9i/ration1 or ent] into contracts = su* submission1 = ! manufacture ( applicable drugs :5 au?oriz$ "u ?is section1 & 9 accordance ) subp>agraph 7,g72 7ii7 acquire rights to manufacture applicable drugs z au?oriz$ "u ?is section2 7iii7 manufacture1 or ent] into contracts ) entities1 ) pref]5ce = nonpr(it entities & public p>tn]s1 to manufacture1 applicable drugs z au?oriz$ "u ?is section2 7iv7 det]m9e a fair price = ea* applicable drug1 9 accordance ) subp>agraph 7,b72 7v7 sell manufactur$ applicable drugs at a fair price z au?oriz$ "u ?is section2 & 7vi7 manufacture1 or ent] into contracts ) entities1 ) pref]5ce = nonpr(it entities & public p>tn]s1 to manufacture active ph>maceutical +r$i5ts = use by ! ,(fice or = sale to o!r entities4 7,b7 ,transp>5cy ,all prices paid & *>g$ = applicable drugs & _! inputs %all be made publicly available by ! ,(fice4 7,c7 ,fair price ,9 det]m9+ a fair price 7! price at :i* ! ,(fice sells an applicable drug to a :olesal] or direct pur*as]7 = an applicable drug "u subp>agraph 7,a77iv7 ! ,(fice %all consid]-- 7i7 ! impact ( price on pati5t access to ! applicable drug2 7ii7 ! co/ ( ! applicable drug to ,f$]al or ,/ate heal? c>e programs2 7iii7 ! co/ to ! ,f$]al ,gov]nm5t ( manufactur+ ! applicable drug2 7iv7 ! adm9i/rative co/s ( op]at+ ! ,(fice2 7v7 ! co/ to acquire or manufacture applicable drugs "u ?is section2 7vi7 ! impact ( price on m>ket competition = ! applicable drug2 7vii7 ! impact ( =mul>y design on pati5t access to ! applicable drug2 & 7viii7 ! co/ to acquire ! applicable drug at ! ,national ,av]age ,drug ,acquisition ,co/4 7,d7 ,acquir+ "r to manufacture & m>ket ,! ,(fice may acquire ! rights to manufacture & m>ket applicable drugs z au?oriz$ "u ?is section4 7,e7 ,active ph>maceutical +r$i5ts 7i7 ,9 g5]al ,! ,(fice %all manufacture1 or ent] into contracts ) entities to manufacture1 an active ph>maceutical +r$i5t if-- 7,i7 ! ,(fice det]m9es t su* +r$i5t is n readily available f exi/+ suppli]s2 7,,ii7 su* +r$i5t is suppli$ by a s+le manufactur+ facility2 7,,iii7 su* +r$i5t is necess>y = ! manufacture ( m$ical c\nt]measures or m$ic9es deem$ ess5tial f a public heal? p]spective2 7,,iv7 ! manufacture ( su* +r$i5t w\ld improve ! ability ( o!r entities to ent] ! m>ket = ! manufacture ( applicable drugs or o!rwise exp& ! manufacture ( applicable drugs2 or 7,v7 ! manufacture ( su* +r$i5t is necess>y =1 or w\ld improve ! ability (1 ! ,(fice to c>ry out its duties "u ?is section4 7ii7 ,price det]m9ations ,9 det]m9+ :at price at :i* to sell an active ph>maceutical +r$i5t "u clause 7i71 ! ,(fice %all consid] ! co/ to manufacture ! +r$i5t1 ! adm9i/rative co/s ( ! ,(fice ) respect to ! +r$i5t1 & ! impact ( su* price on m>ket competition = ! +r$i5t4 7,f7 ,pur*ase requirem5ts ,not)/&+ applicable laws relat+ to ! procurem5t ( prescription drugs1 ! ,(fice %all e/abli% m9imum pur*ase requirem5ts = ! ,dep>tm5t ( ,vet]ans ,affairs1 ! ,dep>tm5t ( ,def5se1 ! ,public ,heal? ,s]vice1 & ! ,coa/ ,gu>d to pur*ase drugs manufactur$ by or z a result ( ! ,(fice4 7,g7 ,limitation on undue influ5ce ,! ,food & ,drug ,adm9i/ration %all consid] an application submitt$ by ! ,(fice "u subp>agraph 7,a77i7 9 ! same mann] 9 :i* ! ,adm9i/ration consid]s applications submitt$ by o!r manufactur]s4 ,no?+ 9 ?is p>agraph %all be con/ru$ to require ! ,food & ,drug ,adm9i/ration to give special def]5ce to any det]m9ation made1 or application submitt$1 by ! ,(fice4 7#e7 ,priority manufactur+ ,! ,(fice %all prioritize ! manufactur+ ( ^? applicable drugs t w\ld h ! greate/ impact on-- 7,a7 l[]+ drug co/s to pati5ts2 7,b7 increas+ competition & address+ drug %ortages 9 ! ph>maceutical m>ket2 7,c7 improv+ public heal?2 7,d7 address+ heal? disp>ities2 7,e7 r$uc+ ! co/ ( prescription drugs to ,f$]al & ,/ate heal? programs2 or 7,f7 address+ public heal? em]g5cies z def9$ 9 ?is ,act1 ! ,national ,em]g5cies ,act1 & ! ,rob]t ,t4 ,/af=d ,disa/] ,relief & ,em]g5cy ,assi/ance ,act1 9 coord9ation ) ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority1 ! ,adm9i/ration = ,/rategic ,prep>$ness & ,response1 ! ,c5t]s = ,disease ,control & ,prev5tion1 & any o!r ,f$]al ag5cy t ! ,(fice det]m9es necess>y1 to enable effici5t procurem5t1 includ+ contract+1 = ! ,f$]al em]g5cy response4 7#f7 ,manufactur+ levels ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 ! ,(fice %all manufacture1 or ent] into contracts ) entities = ! manufacture (1 n less ?an #ae applicable drugs4 ,n lat] ?an #c ye>s aft] su* date ( enactm5t1 ! ,(fice %all manufacture1 or ent] into contracts ) entities = ! manufacture (1 n less ?an #be applicable drugs4 7#g7 ,reports to congress ,! ,director %all prep>e & submit to ! ,presid5t1 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate1 & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 an annual report t includes-- 7,a7 an assessm5t ( ! major problems fac$ by pati5ts 9 access+ af=dable applicable drugs2 7,b7 a description ( ! /atus ( all m$ications = :i* manufactur+ has be5 au?oriz$ "u ?is section1 includ+ m$ications be+ manufactur$1 m$ications = :i* ! ,(fice has submitt$ an application to ! ,food & ,drug ,adm9i/ration b has n yet receiv$ approval1 & m$ications = :i* ! ,(fice has receiv$ approval f ! ,food & ,drug ,adm9i/ration b are n be+ manufactur$2 7,c7 9 ! case ( antibiotics manufactur$ "u ?is section1 an assessm5t f ! ,c5t]s = ,disease ,control & ,prev5tion & ! ,food & ,drug ,adm9i/ration on ! impact ( ! manufactur+ ( antibiotics on antimicrobial resi/ance2 7,d7 an acc\nt+ ( funds receiv$ f ! sale ( all m$ications = :i* manufactur+ has be5 au?oriz$ "u ?is section & ! use ( su* funds2 7,e7 an analysis ( h[ ! public manufacture ( drugs meet+ ! conditions describ$ 9 p>agraph 7#e7 w\ld impact1 or has already impact$1 competition1 access to su* drugs1 ! co/s ( su* drugs1 ! co/s ( prescription drugs to ,f$]al & ,/ate heal? programs1 & public heal?2 & 7,f7 a description ( ! *all5ges fac$ by ! ,(fice 9 c>ry+ out its duties "u p>agraph 7#d74 7b7 ,submission ( applications ,= ea* applicable drug t ! ,(fice det]m9es %\ld be manufactur$1 z provid$ = "u ?is section1 ! ,(fice %all-- 7#a7 submit an application "u section #eje7;b77#b71 #eje7;j71 or #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea7;a7 or #cea7k7 ( ?is ,act or submit a notification "u section #eaj7k7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7or ent] into a contract ) ano!r entity to submit su* an application72 7#b7 reque/ an em]g5cy use au?orization ( ! product1 z appropriate1 "u section #efd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7or ent] into a contract ) ano!r entity to submit an application = su* use72 or 7#c7 acquire f ! hold] ( an application approv$ "u subsection 7c7 or 7j7 ( section #eje or section #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea ( ?is ,act1 or cle>$ "u section #eaj7k7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 rights to manufacture su* applicable drug4 7c7 ,use 7#a7 ,9 g5]al ,! ,(fice %all sell a drug produc$ "u ?is section at a fair price to o!r entities4 ,am\nts receiv$ by ! ,(fice f ! sale ( su* drugs %all be us$ = ! activities ( ! ,(fice4 7#b7 ,sale ( approv$ application 7,a7 ,availability 7i7 ,9 g5]al ,= any applicable drug t ! ,(fice is manufactur+1 ! ,(fice %all1 beg9n+ #c ye>s aft] ! date on :i* ! ,(fice fir/ und]takes manufactur+ ( su* drug & annually !reaft]1 make available = sale1 to any p]son :o commits to manufactur+ & m>ket+ ! applicable drug1 ! approv$ application = ! drug4 7ii7 ,cont9u$ compliance ) ,,fda requirem5ts ,! ,(fice %all ensure t any application pur*as$ "u clause 7i7 is consi/5t ) exi/+ /&>ds appli$ by ! ,food & ,drug ,adm9i/ration relat$ to ! transf] ( own]%ip rights = an approv$ application1 includ+ any additional fil+ requirem5ts t ! pur*as] w\ld ne$ to be 9 compliance ) due to mat]ial *anges 9 in=mation provid$ 9 ! approv$ application4 7,b7 ,failure to use ,if ! ,(fice makes a det]m9ation t a p]son pur*as+ an approv$ application "u subp>agraph 7,a7-- 7i7 fails to m>ket ! applicable drug )9 #f mon?s ( ! date ( su* pur*ase2 or 7ii7 increases ! av]age manufactur] price = ! applicable drug above ! fair price 7increas$ by ! consum] price index = all urban consum]s 7z publi%$ by ! ,bureau ( ,labor ,/ati/ics7 = t ye>71 ! ,(fice %all revoke ! pur*as]'s approv$ application & resume production ( ! applicable drug4 ,! ,(fice may waive ! application ( ?is subp>agraph 9 ! case ( a ,national ,em]g5cy or 9 any o!r case det]m9$ appropriate by ! ,(fice4 7d7 ,ensur+ pati5t access 7#a7 ,9 g5]al ,! ,(fice %all c>ry out appropriate activities to ensure ! di/ribution & cov]age ( all applicable drugs t ! ,(fice is manufactur+ or has ent]$ into a contract to manufacture "u ?is section4 7#b7 ,advisory c\ncil ,! ,(fice %all e/abli% an advisory c\ncil to in=m ! ,(fice on ! id5tification ( applicable drugs1 m>ket l&scape1 & supply *a9 consid]ations to ensure deliv]y ( applicable drugs to consum]s4 ,! advisory committee %all include repres5tatives f community & retail ph>macies1 ph>macy b5efit manag]s1 drug :olesal]s1 hospitals1 heal? plans1 indep5d5t pati5t gr\ps1 cl9icians1 & consum] advocacy organizations4 7e7 ,insul9 ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 ! ,(fice %all beg9 ! public manufactur+ ( at lea/ #a insul9 product ( ea* dosage =m 7su* z vial1 pump1 or p5 dosage =ms7 & ( ea* diff]5t type ( insul9 7su* z rapid-act+1 %ort-act+1 int]m$iate-act+1 long-act+1 ultra-long act+1 & premix$71 meet+ ! def9ition ( applicable drug & 9 accordance ) ?is section4 7f7 ,a/hma & ,,copd inhal]s ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 ! ,(fice %all beg9 ! public manufactur+ ( at lea/ #a inhal]1 meet+ ! def9ition ( applicable drug & 9 accordance ) ?is section4 7g7 ,ep9ephr9e auto-,injector ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 ! ,(fice %all beg9 ! public manufactur+ ( an ep9ephr9e auto-injector1 meet+ ! def9ition ( applicable drug & 9 accordance ) ?is section4 7h7 ,naloxone ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 ! ,(fice %all beg9 ! public manufactur+ ( naloxone1 includ+ naloxone indicat$ = community use1 meet+ ! def9ition ( applicable drug & 9 accordance ) ?is section4 7i7 ,antibiotics ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 & 9 consultation ) ! ,c5t]s = ,disease ,control & ,prev5tion & ! ,food & ,drug ,adm9i/ration to ensure ! appropriate use ( manufactur$ antibiotics1 ! ,(fice %all beg9 ! public manufactur+ ( no few] ?an ?ree discrete antibiotics meet+ ! def9ition ( applicable drug 9 accordance ) ?is section4 7j7 ,applicable drug ,9 ?is section1 ! t]m applicable drug means a drug 7z def9$ 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act71 biological product 7z def9$ 9 section #cea ( ! ,public ,heal? ,s]vice ,act71 or comb9ation product 7z describ$ 9 section #ejc7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act7 = :i* an approv$ application "u section #eje or #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 or cle>ance "u section #eaj7k7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 is 9 effect1 &-- 7#a7 7,a7 = :i*1 ) respect to a drug includ$ 9 ! li/ describ$ 9 section #eje7;j77#g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 ea* pat5t includ$ ) respect to su* drug 9 su* li/ has expir$1 or ea* pat5t t claims a biological product has expir$2 7,b7 any p]iod ( regulatory exclusivity grant$ "u-- 7i7 clause 7ii71 7iii71 or 7iv7 ( section #eje7;c77#c77;,e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 section #eje7;j77#e77;,b77iv7 ( su* ,act1 clause 7ii71 7iii71 or 7iv7 ( section #eje7;j77#e77;,f7 ( su* ,act1 section #ebg ( su* ,act1 & any ext5sion ( su* a p]iod grant$ "u section #eje;,a or #eje;,e ( su* ,act1 has expir$2 or 7ii7 p>agraph 7#f7 or 7#g7 ( section #cea7k7 ( ! ,public ,heal? ,s]vice ,act1 & any ext5sion ( su* a p]iod grant$ "u p>agraph 7#b7 or 7#c7 ( section #cea7m7 ( su* ,act1 has expir$2 & 7,c7 7i7 t is n be+ m>ket$ 9 ! ,unit$ ,/ates2 or 7ii7 t is be+ m>ket$ 9 ! ,unit$ ,/ates by #c or few] manufactur]s ) an approv$ abbreviat$ new drug application or biosimil> 7n includ+ manufactur]s ( au?oriz$ g5]ics "u a new drug application or biosimil>71 & t-- 7,i7 9 ! previ\s #e-ye> p]iod1 has exp]i5c$ an increase 9 ! :olesale acquisition co/ by at lea/ #a ( its manufactur]s t is great] ?an ! consum] price index = all urban consum]s 7z publi%$ by ! ,bureau ( ,labor ,/ati/ics7 = #a ( ! ye>s 9 t ! same p]iod2 7,,ii7 is includ$ 9 ! drug %ortage li/ "u section #ejf;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 or 7,,iii7 7aa7 has an av]age :olesale acquisition co/ t ! ,(fice det]m9es to be a b>ri] to pati5t access2 & 7bb7 is li/$ by ! ,_w ,heal? ,organization z an ess5tial m$ic9e2 or 7#b7 = :i* !re is 9 effect a lic5se1 or pat5t use is au?oriz$1 "u-- 7,a7 section #adih ( title #bh1 ,unit$ ,/ates ,code2 7,b7 section #bjb ( title #ce1 ,unit$ ,/ates ,code2 7,c7 section #bjc ( title #ce1 ,unit$ ,/ates ,code 7m>*-9 rights72 7,d7 section #bji ( title #ce1 ,unit$ ,/ates ,code2 or 7,e7 any o!r lic5s+ au?ority ( ! ,f$]al ,gov]nm5t4 7k7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ su* sums z may be necess>y to c>ry out ?is section4 4