,,ii #aac? ,,congress #b;d ,session ,s4 #bacd ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,m>* #ac1 #bjad ,mr4 ,man*9 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to )draw approval = ! drug ,zohydro ,,er & prohibit ! ,food & ,drug ,adm9i/ration f approv+ su* drug unless x is re=mulat$ to prev5t abuse4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,act to ,ban ,zohydro4 #b4 ,f9d+s ,congress f9ds z foll[s3 7#a7 ,! drug ,zohydro ,,er is a high-dose hydrocone-only opioid n>cotic pa9kill] li/$ 9 s*$ule ,,ii ( section #bjb7;c7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hab7;c774 7#b7 ,! ,food & ,drug ,adm9i/ration ,ane/hetic & ,analgesic ,drug ,products ,advisory ,committee report cit$ available dosages ( ,zohydro ,,er t1 accord+ to heal? c>e & sub/ance abuse pr(essionals1 h up to #aj times m hydrocodone ?an any hydrocodone pa9kill] curr5tly on ! m>ket4 7#c7 ,zohydro ,,er is manufactur$ )\t an abuse det]r5t =mulation4 7#d7 ,zohydro's "t-releas$ effect1 an important elem5t ( its ph>maceutical use1 is easily negat$ by abus]s to a*ieve a h]o9-l effect4 7#e7 ,! ,ane/hetic & ,analgesic ,drug ,products ,advisory ,committee conclud$ t1 if approv$ & m>ket$1 ,zohydro ,,er w be abus$1 possibly at a rate great] ?an t ( curr5tly available hydrocodone comb9ation products4 7#f7 ,! ,ane/hetic & ,analgesic ,drug ,products ,advisory ,committee vot$ #aa to #b aga9/ approval ( ,zohydro ,,er1 cit+ ! high possibility = addiction4 7#g7 ,! ,food & ,drug ,adm9i/ration approv$ ,zohydro ,,er )\t an abuse det]r5t =mulation despite ! fact t ! ,ane/hetic & ,analgesic ,drug ,products ,advisory ,committee vot$ #aa to #b aga9/ do+ s4 7#h7 ,! ,food & ,drug ,adm9i/ration has ackn[l$g$ t ! widespread abuse ( opioid drugs across ! c\ntry has rea*$ epidemic proportions 9 "s p>ts ( ! c\ntry4 7#i7 ,accord+ to ! ,c5t]s = ,disease ,control & ,prev5tion1 dea?s connect$ to prescription opioids h m ?an quadrupl$ 9 ! ,unit$ ,/ates1 f #d1jcj dea?s involv+ ! pa9kill]s 9 #aiii to #af1fea dea?s 9 #bjaj4 7#aj7 ,! ,c5t]s = ,disease ,control & ,prev5tion has id5tifi$ r$uc+ dea?s attributable to prescription pa9kill] abuse & ov]dose z a top heal? priority = #bjad4 7#aa7 ,attorneys ,g5]al f #bh ,/ates h ask$ ! ,food & ,drug ,adm9i/ration to reconsid] its approval ( ,zohydro ,,er4 7#ab7 ,heal? c>e pr(essionals1 addiction treatm5t provid]s1 & community-bas$ drug & alcohol prev5tion programs are gr\ps oppos$ to ! approval ( ,zohydro ,,er4 7#ac7 ,! burd5s ( ,zohydro ,,er to ! public heal? outweigh its pot5tial !rapeutic b5efits4 ,giv5 t alt]native pa9 m$ic9es & me?ods are widely available1 approval ( ,zohydro ,,er %\ld be )drawn until su* "t t !re is available a ,food & ,drug ,adm9i/ration-approv$ abuse det]r5t =mulation4 #c4 ,)drawal ( approval ( drug ,zohydro ,,er 7a7 ,)drawal ( approval ,effective beg9n+ on ! day t is #de days aft] ! date ( enactm5t ( ?is ,act1 approval ( ! application ) respect to pure hydrocodone bit>trate ext5d$-release capsules 7m>ket$ z ! drug ,zohydro ,,er7 "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77 is deem$ to h be5 )drawn "u section #eje7;e7 ( su* ,act 7#ba ,u4,s4,c4 #cee7;e774 7b7 ,no approval ( any =mulation t is n abuse det]r5t ,! ,commission] ( ,food & ,drugs %all n approve any application "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 = pure hydrocodone bit>trate ext5d$-release capsules unless su* drug is =mulat$ to prev5t abuse4