,i #aaf? ,,congress #a/ ,session ,h4 ,r4 #eaih ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,novemb] #bj1 #bjai,mr4 ,gold5 7= himself & ,mr4 ,c>t] ( ,georgia7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act reg>d+ ! pati5t m$ication in=mation requir$ to be includ$ 9 ! label+ ( prescription drugs1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,pati5ts' ,"r to ,"k ,_! ,m$ication ,act ( #bjai4 #b4 ,f9d+s ,congress f9ds ! foll[+3 7#a7 ,prescription m$ications are important to ! heal? & well-be+ ( ! ,am]ican public4 7#b7 ,accord+ to ! ,c5t]s = ,disease ,control & ,prev5tion 7,,cdc71 #dh4i p]c5t ( ,am]icans us$ at lea/ "o prescription drug 9 ! pa/ #cj days4 7#c7 ,! utilization ( prescription drugs c subject pati5ts to adv]se drug ev5ts2 !re=e1 pati5t safety is ( ! utmo/ importance4 7#d7 ,/udies indicate t pap] =mat pati5t m$ication in=mation 7,,pmi7 c help protect pati5ts & prev5t ! majority ( co/ly adv]se drug ev5ts4 7#e7 ,9 addition to bol/]+ pati5t safety1 ! m&atory use ( a /&>diz$ ,,pmi provid$ to all pati5ts 9 nonhospital sett+s c\ld r$uce co/s associat$ ) em]g5cy room visits & hospital admissions relat$ to adv]se drug ev5ts by #ad4f to #bf4b billion doll>s annually4 7#f7 ,_m pati5ts _c access electronic v]sions ( ,,pmi1 !reby necessitat+ a pap] option4 7#g7 ,! ,gov]nm5t ,acc\ntability ,(fice f\nd t rely+ on electronic label+ z a complete sub/itute = pap] label+ c\ld adv]sely impact public heal?4 7#h7 ,a congressionally m&at$ pap] ,,pmi is ne$$ because no /&>diz$ ,,pmi 9 a s+le page1 pap] copy1 prov5 pati5t-fri5dly =mat is curr5tly available to pati5ts or requir$ by ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 #c4 ,pati5t m$ication in=mation = prescription drugs 7a7 ,9 g5]al ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by ins]t+ aft] section #eje;,f 7#ba ,u4,s4,c4 #cee;g7 ! foll[+3 #eje;,g4 ,pati5t m$ication in=mation = prescription drugs 7a7 ,9 g5]al ,! ,secret>y %all issue regulations on ! pati5t m$ication in=mation t is requir$ to be 9 ! pr9t$ label+ ( drugs subject to section #ejc7;b77#a71 includ+ regulations reg>d+ ! au?or%ip1 cont5t1 =mat1 color1 pr9t+1 & dissem9ation requirem5ts = su* pati5t m$ication in=mation4 ,! ,secret>y %all issue f9al regulations pursuant to ! prec$+ s5t5ce n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section4 7b7 ,cont5t ,! regulations promulgat$ "u subsection 7a7 %all require t ! pati5t m$ication in=mation ) respect to a drug-- 7#a7 be sci5tifically accurate1 include relevant pati5t safety in=mation1 & be approv$ by ! ,secret>y2 7#b7 include und]/&able pla9 language1 & include graphics & pictures :5 applicable1 & be provid$ 9 a consi/5t1 /&>diz$ =mat & color = all drug products1 & n be promotional 9 tone or cont5t1 & conta9 at lea/-- 7,a7 ! e/abli%$ "n ( ! drug 7or1 if ! drug is a biological product1 ! prop] "n ( ! biological product7 & ! national drug code = ! drug2 7,b7 indications = use approv$ by ! ,food & ,drug ,adm9i/ration2 7,c7 g5]al directions = prop] use2 7,d7 contra9dications1 w>n+s1 precautions1 ! mo/ frequ5tly occurr+ adv]se reactions1 & adv]se reactions t are important = o!r reasons 7su* z because !y are s]i\s71 especially ) respect to c]ta9 subpopulations su* z *ildr51 pregnant wom51 & ! eld]ly2 7,e7 measures pati5ts may be able to take1 if any1 to r$uce ! side effects & risks ( ! drug2 7,f7 in=mation ab\t :5 a pati5t %\ld contact 8 or h] heal? c>e pr(essional2 7,g7 in/ructions n to %>e m$ications1 &1 if applicable1 key /orage requirem5ts & recomm5dations relat+ to prop] disposal ( any unus$ portion ( ! drug2 7,h7 kn[n cl9ically important int]actions ) o!r drugs1 food1 & o!r sub/ances2 7,i7 a /atem5t ( :e!r suffici5t data are available conc]n+ ! use ( ! drug 9 specifi$ subpopulations1 su* z wom51 pregnant wom51 lactat+ wom51 wom5 & m5 ( reproductive age1 & p$iatric1 g]iatric1 racial1 & e?nic m9ority gr\ps2 7,j7 ! "n ( ! manufactur] & a toll-free telephone numb] = consum]s to contact ! manufactur] ( ! drug2 & 7,k7 a curr5t l9k to ,=m ,,fda #cejj;,b = volunt>y report+ = consum]s ( adv]se ev5ts1 product problems1 & product use errors 7or any successor =m72 & 7#c7 be provid$ to a pati5t or ag5t ( a pati5t 9 a pr9t$ =mat ) ea* prescription disp5s$1 su* t a drug label$ = di/ribution %all be accompani$ by pr9t$ label+ physically on or )9 ! packag+ f :i* ! drug is to be disp5s$1 9 an adequate supply ( pr9t$ pati5t m$ication in=mation to accommodate prescriptions disp5s$ !refrom4 7c7 ,timel9ess1 consi/5cy1 accuracy1 & effectiv5ess ,! regulations promulgat$ "u subsection 7a7 %all-- 7#a7 provide = timely reviews1 approvals1 & updates ( pati5t m$ication in=mation z new drugs & new in=mation become available2 7#b7 provide = updates :5 appropriate to help communicate in=mation t is %>$ by simil> products or drugs )9 classes ( m$ication to avoid pati5t confusion & h>m2 7#c7 include specifications = language1 graphics1 =mat1 color1 & pictures requir$ by subsection 7b77#b71 to be develop$ bas$ ^u docum5t$ pati5t rese>* ) "o or m actual drug products t demon/rates improv$ pati5t le>n+ & und]/&+ ( safe & effective m$ication use2 & 7#d7 be bas$ on a demon/rat$ causal connection betwe5 ! enhanc$ pati5t m$ication in=mation requir$ by ! regulations & improv$ pati5t m$ication adh]5ce & compliance = ! purpose ( r$uc+ ! co/ ( heal? c>e & improv+ desir$ m$ical outcomes4 4 7b7 ,misbr&+ (f5se ,section #ejb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is am5d$ by add+ at ! end ! foll[+3 7ee7 ,if x is a drug subject to section #ejc7;b77#a7 & pati5t m$ication in=mation is n provid$ 9 accordance ) section #eje;,g4 4