,i #aaf? ,,congress #b;d ,session ,h4 ,r4 #eibg ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,febru>y #ah1 #bjbj,mr4 ,posey introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to direct ! ,secret>y ( ,heal? & ,human ,s]vices to /udy ,am]ican dep5d5ce on unsafe ,*9ese ph>maceuticals & to emp[] ! ,food & ,drug ,adm9i/ration to m&ate drug recalls 9 ! case ( critical contam9ation4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,safe ,m$ic9e ,act4 #b4 ,f9d+s 7a7 ,f9d+s ,congress f9ds ! foll[+3 7#a7 ,foll[+ ! enactm5t ( ! ,drug ,price ,competition & ,pat5t ,t]m ,re/oration ,act ( #aihd 7,public ,law #ih-dag71 ! ,p's ,republic ( ,*9a 0 able to corn] ! m>ket on g5]ic drugs1 ph>maceutical +r$i5ts1 & relat$ mat]ials ?r\gh its /eady supply ( readily exploitable labor & ?readb>e safety regulations4 ,n9ety p]c5t ( ! m$ications tak5 by individuals 9 ! ,unit$ ,/ates are g5]ic1 r5d]+ !m especially dep5d5t on supplies orig9at+ 9 ! ,p's ,republic ( ,*9a4 7#b7 ,! numb] ( drugs produc$ outside ( ! ,unit$ ,/ates d\bl$ betwe5 #bjja & #bjjh4 ,at pres5t1 #hj p]c5t ( ! active ph>maceutical +r$i5ts us$ 9 drugs tak5 by individuals 9 ! ,unit$ ,/ates come f ov]seas1 ma9ly ! ,p's ,republic ( ,*9a & ! ,republic ( ,india4 ,! ,unit$ ,/ates no long] produces p5icill91 ) ! la/ f]m5tation plant phas+ out ( production 9 #bjjd4 7#c7 ,9 #bjjh1 ! c\nt]feit+ ( ,hep>9 precursor *emicals by a ,*9ese-bas$ ph>maceutical plant l$ to ! dea?s ( #ha individuals 9 ! ,unit$ ,/ates1 ) #ghe m be+ sev]ely injur$4 ,! c\nt]feit product co/ "o-hundr$? ( ! price ( ! real product1 indicat+ a cle> economic motive = di/ribut+ contam9at$ mat]ials4 7#d7 ,9 #bjah1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 issu$ recalls ( vals>tan1 los>tan1 & irbes>tan1 common blood pressure drugs4 ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 det]m9$ t v]sions ( su* drugs h be5 contam9at$1 z a result ( ,*9ese & ,indian manufactur+ practices & t "o ,*9ese company1 ,zhejaiang ,huahai ,ph>maceuticals _h sy/emic problems ( sup]vision1 ) ! pot5t c>c9og5s ,n-,nitroso-,n-me?yl-#d-;am9obutyric acid 7,,nmba71 ,n-,nitrosodime?ylam9e 7,,ndma71 & ,n-,nitrosodie?ylam9e 7,,ndea71 = a p]iod ( #d ye>s be=e be+ detect$4 7#e7 ,dome/ic ph>maceutical facilities are inspect$ e #b ye>s1 :]eas =eign ph>maceutical facilities are inspect$ only e #i ye>s4 ,fur!r1 inspections ( =eign facilities by ! ,food & ,drug ,adm9i/ration h decl9$ 9 ! pa/ #b ye>s4 ,9 ! ,p's ,republic ( ,*9a1 ^! inspections h fall5 by m ?an #aj p]c5t4 7#f7 ,9 #bjaj1 ! ,p's ,republic ( ,*9a emb>go$ ! %ipm5t ( r>e e>? metals to ,japan z political lev]age 9 its negotiations ov] a boat+ incid5t t took place betwe5 ! two c\ntries 9 ! ,ea/ ,*9a ,sea4 ,national security exp]ts w>n t if su* an incid5t 7 to take place betwe5 ! ,unit$ ,/ates & ,*9a1 & ,*9a 7 to emb>go m$ic9e & ph>maceutical +r$i5ts1 ! ,unit$ ,/ates w\ld be helpless4 ,unit$ ,/ates dep5d5ce on ,*9ese m$ic9e & ph>maceutical +r$i5ts poses a national security risk4 7b7 ,purposes ,! purposes ( ?is ,act are-- 7#a7 to direct ! ,secret>y ( ,heal? & ,human ,s]vices to /udy ! dep5d5ce ( ! ,unit$ ,/ates on unsafe ,*9ese drugs2 & 7#b7 to au?orize ! ,food & ,drug ,adm9i/ration to ord] a tempor>y box$ w>n+ on pot5tially contam9at$ drugs4 #c4 ,/udy ( dep5d5ce ( ,unit$ ,/ates on ,*9ese drugs ,n lat] ?an "o ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 9 consultation ) ! heads ( o!r appropriate ,f$]al dep>tm5ts & ag5cies1 %all submit to ,congress a report on vuln]abilities to ! ,unit$ ,/ates m$ic9e supply *a94 ,su* report %all include-- 7#a7 an id5tification ( any f9i%$ drugs & _! ess5tial compon5ts includ+ raw mat]ials1 *emical compon5ts1 & active +r$i5ts necess>y = ! manufacture ( m$ic9es ^: supply is at risk ( disruption due to dep5d5ce on a s+le or limit$ numb] ( provid+ c\ntries2 7#b7 an id5tification ( ! def5se & geopolitical cont+5cies t are suffici5tly likely to arise t may disrupt1 /ra91 compromise1 or elim9ate supply *a9s ( m$ic9es & _! ess5tial compon5ts & recomm5dations = reasonable prep>ation = ! occurr5ce ( su* cont+5cies2 7#c7 an assessm5t ( ! resili5ce & capacity ( ! curr5t supply *a9 & indu/rial base to support ! population ( ! ,unit$ ,/ates ^u ! occurr5ce ( ! cont+5cies id5tifi$ pursuant to p>agraph 7#b71 includ+ ) respect to-- 7,a7 ! manufactur+ capacity ( ! ,unit$ ,/ates2 7,b7 gaps 9 dome/ic manufactur+ capabilities includ+ non-exi/5t1 ext9ct1 ?reat5$1 & s+le-po9t-(-failure capabilities2 & 7,c7 supply *a9s ) s+le po9ts ( failure & limit$ resili5cy2 7#d7 legislative1 regulatory1 & policy *anges necess>y to avoid1 or prep>e =1 cont+5cies id5tifi$ pursuant to p>agraph 7#b72 7#e7 recomm5dations to div]sify supply away f pr$om9ant dep5d5cy on s\rces ( supply 9 competitor c\ntries & politically un/able c\ntries t may cut (f ,unit$ ,/ates supply1 & address critical bottl5ecks & mitigate s+le po9ts ( failure & limit$ resili5ce2 & 7#f7 an assessm5t ( ! pot5tial impact on dome/ic drug prices if ! ,p's ,republic ( ,*9a 7 to emb>go ! export ( drugs & ph>maceutical +r$i5ts to ! ,unit$ ,/ates4 #d4 ,au?oriz+ tempor>y box$ w>n+s on pot5tially contam9at$ drugs ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 may issue a tempor>y ord] deem+ c]ta9 drugs to be misbr&$ )9 ! mean+ ( section #ejb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb71 if-- 7#a7 su* drugs1 or ! active ph>maceutical +r$i5ts !re(1 are manufactur$ 9 a c\ntry t ! ,secret>y det]m9es may be produc+ contam9at$ drugs 7or active ph>maceutical +r$i5ts7 because ( sy/emic problems ( sup]vision 9 ! manufacture ( su* drugs or active ph>maceutical +r$i5ts2 & 7#b7 ! label+ ( su* drugs does n be> a box$ w>n+ ( ! pot5tial = contam9ation4