,,ii #aad? ,,congress #a/ ,session ,s4 #aecb ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,june #i1 #bjae ,mrs4 ,murray 7= h]self1 ,mrs4 ,box]1 ,mrs4 ,%ahe51 ,mr4 ,reid1 ,mr4 ,blum5?al1 ,ms4 ,baldw91 ,mr4 ,b5net1 ,mr4 ,book]1 ,mr4 ,br[n1 ,ms4 ,cantwell1 ,mr4 ,c>d91 ,mr4 ,durb91 ,mrs4 ,fe9/e91 ,mrs4 ,gillibr&1 ,mr4 ,he9ri*1 ,ms4 ,hirono1 ,mr4 ,ka9e1 ,ms4 ,klobu*>1 ,mr4 ,leahy1 ,mrs4 ,mc,caskill1 ,mr4 ,m]kley1 ,ms4 ,mikulski1 ,mr4 ,murphy1 ,mr4 ,s&]s1 ,mr4 ,s*atz1 ,mr4 ,s*um]1 ,mr4 ,frank51 ,ms4 ,/ab5[1 ,ms4 ,w>r51 ,mr4 ,wyd51 & ,mr4 ,m55dez7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to ensure timely access to af=dable bir? control = wom54 #a4 ,%ort title ,?is ,act may be cit$ z ! ,af=dability ,is ,access ,act4 #b4 ,purpose ,! purpose ( ?is ,act is to ensure timely access to af=dable bir? control by requir+ cov]age )\t co/-%>+ = oral bir? control = r\t9e1 daily use t is approv$ by1 or o!rwise legally m>ket$ "u regulation by1 ! ,food & ,drug ,adm9i/ration = use by wom5 )\t a prescription4 #c4 ,f9d+s ,congress makes ! foll[+ f9d+s3 7#a7 ,access to ! full range ( heal? b5efits & prev5tive s]vices1 includ+ access to bir? control1 z gu>ante$ "u ,f$]al law1 provides all p ( ! ,unit$ ,/ates ) ! opportunity to lead heal?i] & m productive lives4 7#b7 ,bir? control is a critical heal? c>e b5efit & s]vice = wom54 ,almo/ all wom5 use bir? control at "s po9t 9 _! lifetimes4 ,! ,c5t]s = ,disease ,control & ,prev5tion decl>$ x "o ( ! ,t5 ,great ,public ,heal? ,a*ievem5ts ( ! #bj? ,c5tury4 7#c7 ,bir? control prev5ts & r$uces un9t5d$ pregnancies & provides _m heal? & socioeconomic b5efits = wom54 ,wom5 ) access to bir? control are m likely to h high] educational & c>e] a*ievem5t1 & to e>n high] wages4 7#d7 ,af=dability & timely access h long be5 b>ri]s = wom5 be+ able to use bir? control4 ,_m wom5 /ruggle to obta9 ! bir? control !y ne$ because ( co/ or o!r access b>ri]s1 :i* has contribut$ to ! high un9t5d$ pregnancy rate 9 ! ,unit$ ,/ates4 ,a national survey f\nd t #a 9 #c wom5 h /ruggl$ to af=d bir? control at "s po9t 9 _! lives1 & z a result1 h us$ bir? control inconsi/5tly4 ,! rate is ev5 high] = "y wom5 :o are mo/ likely to exp]i5ce an un9t5d$ pregnancy4 7#e7 ,?ree sep>ate /udies h f\nd t lack ( heal? cov]age is significantly associat$ ) r$uc$ use ( prescription contraceptive me?ods1 includ+ bir? control4 7#f7 ,! ,pati5t ,protection & ,af=dable ,c>e ,act 7,public ,law #aaa-adh7 s\ght to remove b>ri]s to c>e & improve access by requir+ all new heal? plans to cov] recomm5d$ prev5tive s]vices )\t co/-%>+1 :i* include wom5's prev5tive s]vices1 includ+ all contraceptive me?ods1 includ+ bir? control & /]ilization = wom5 approv$ by ! ,food & ,drug ,adm9i/ration & relat$ education & c\nsel+4 7#g7 ,! ,pati5t ,protection & ,af=dable ,c>e ,act wom5's prev5tive s]vices b5efit has significantly improv$ wom5's access to bir? control1 includ+ oral bir? control = r\t9e1 daily use4 ,! ,dep>tm5t ( ,heal? & ,human ,s]vices has report$ t1 z ( #bjad1 m ?an #ee1jjj1jjj wom5 are b5efitt+ f cov]age )\t co/-%>+ = wom5's prev5tive s]vices1 includ+ bir? control1 "u ! ,pati5t ,protection & ,af=dable ,c>e ,act4 ,wom5 h sav$ m ?an #dhc1jjj1jjj 9 out-(-pocket co/s = bir? control ) no copaym5ts 9 #bjab comp>$ to #bjac1 an av]age sav+s ( #bfi p] woman4 7#h7 ,! mo/ appropriate me?od ( bir? control v>ies accord+ to ea* individual woman's ne$s1 m$ical hi/ory1 & /age ( life4 ,= in/ance1 wom5 may h m$ical contra9dications t limit _! ability to use c]ta9 bir? control me?ods4 ,x is critical t ! full range ( bir? control me?ods approv$ by ! ,food & ,drug ,adm9i/ration are available & cov]$ )\t co/-%>+ 9 ord] to ensure t ea* woman has access to ! bir? control me?od t be/ meet h] ne$s4 7#i7 ,! det]m9ation z to :e!r a drug %\ld be available = use )\t a prescription is appropriately & solely made by ! ,food & ,drug ,adm9i/ration4 ,to ensure ! safety & efficacy ( a drug1 includ+ a drug available = ov]-!-c\nt] use1 ! appropriate sci5tific & m$ical p]sonnel at ! ,food & ,drug ,adm9i/ration1 (t5 ) input f indep5d5t advisory panels ( exp]ts1 review cl9ical & o!r data relat+ to ! safety & efficacy ( ! drug4 ,?is sci5tific & m$ical review c occur z "p ( ! ,food & ,drug ,adm9i/ration's ov]-!-c\nt] drug review = pot5tial inclusion 9 a monograph z g5]ally recogniz$ z safe & effective1 or z "p ( ! review ( a new drug application 7or an abbreviat$ new drug application74 ,z "p ( ^! regulatory processes1 ! appropriate sci5tific & m$ical p]sonnel review cl9ical & o!r data1 includ+ data g5]at$ 9 controll$ cl9ical trials4 ,! ,food & ,drug ,adm9i/ration also reviews consum] /udies & monitors po/-m>ket+ safety data4 ,all ( ^! processes ensure t ! appropriate sci5tific & m$ical p]sonnel make ! det]m9ation ( safety1 quality1 & efficacy ( drugs m>ket$ to ! p ( ! ,unit$ ,/ates4 7#aj7 ,lead+ wom5's heal? exp]ts1 provid]s1 & m$ical associations1 includ+ ! ,am]ican ,college ( ,ob/etricians & ,gynecologi/s & ! ,am]ican ,academy ( ,family ,physicians1 support full insurance cov]age & increas$ access to oral bir? control ov]-!-c\nt]4 ,9 #bjab1 ! ,am]ican ,college ( ,ob/etricians & ,gynecologi/s issu$ a ,committee ,op9ion recomm5d+ approval by ! ,food & ,drug ,adm9i/ration ( c]ta9 =ms ( bir? control = ov]-!-c\nt] use to increase timely access to bir? control4 ,fur!rmore1 data demon/rates t bir? control t is available ov]-!-c\nt] has public support & w\ld increase bir? control usage & cont9uation4 ,! ,committee ,op9ion foll[$ simil> recomm5dations made by lead+ reproductive heal? exp]ts & publi%$ 9 ! ,am]ican ,j\rnal ( ,public ,heal?4 7#aa7 ,rese>* %[s t bir? control available ov]-!-c\nt]1 z an addition to1 n a sub/itute =1 ! wom5's prev5tive heal? b5efit "u ! ,pati5t ,protection & ,af=dable ,c>e ,act1 w\ld increase accessibility = oral bir? control = r\t9e1 daily use4 #d4 ,s5se ( ! ,s5ate ,x is ! s5se ( ! ,s5ate t-- 7#a7 9 ord] to increase wom5's access to oral bir? control1 x mu/ be bo? easi] to obta9 & af=dable &1 to make x ei!r easi] to obta9 or m af=dable1 b n bo?1 is to leave unacceptable b>ri]s 9 place = wom52 7#b7 x is imp]ative t ! entities t rese>* & develop oral bir? control & ^: m$ical & sci5tific exp]ts h develop$ cl9ical & o!r evid5ce t oral bir? control = r\t9e1 daily use is safe & effective = wom5 :5 sold )\t a prescription1 apply to ! ,food & ,drug ,adm9i/ration = review & approval = sale ( su* bir? control )\t a prescription2 7#c7 ^u ! receipt ( su* an application1 ! ,food & ,drug ,adm9i/ration %\ld det]m9e :e!r ! oral bir? control meets ! rigor\s safety1 efficacy1 & quality /&>ds = ov]-!-c\nt] use "u ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq471 & if ! product meets ^? /&>ds1 ! ,food & ,drug ,adm9i/ration %\ld approve ! application )\t delay2 & 7#d7 if & :5 ! ,food & ,drug ,adm9i/ration approves an oral bir? control t is available ov]-!-c\nt]1 su* bir? control %\ld be cov]$ by heal? insurance1 )\t a prescription & )\t co/-%>+4 #e4 ,ensur+ cov]age ( oral bir? control = use )\t a prescription ,section #bgac7;a77#d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ac7;a77#d77 is am5d$ by ins]t+ 7includ+ oral contraceptives = r\t9e1 daily use approv$ by ! ,food & ,drug ,adm9i/ration = use )\t a prescription1 ev5 if ! individual does n h a prescription = su* contraceptive7 aft] additional prev5tive c>e4 #f4 ,rules ( con/ruction 7a7 ,non-,int]f]5ce ) ,,fda regulation ,no?+ 9 ?is ,act 7or ! am5dm5t made by ?is ,act7 %all be con/ru$ to modify or int]f]e ) ,food & ,drug ,adm9i/ration processes to review or approve1 or o!rwise det]m9e ! safety & efficacy (1 & make available1 non-prescription drugs or devices1 modify or int]f]e ) ! sci5tific & m$ical consid]ations ( ! ,food & ,drug ,adm9i/ration1 or alt] any o!r au?ority ( ! ,food & ,drug ,adm9i/ration4 7b7 ,non-,preemption ,no?+ 9 ?is ,act 7or ! am5dm5t made by ?is ,act7 preempts any provision ( ,f$]al or ,/ate law to ! ext5t t su* ,f$]al or ,/ate law provides protections = consum]s t are great] ?an ! protections provid$ = 9 ?is ,act4 #g4 ,duties ( retail]s to ensure access to oral bir? control = use )\t a prescription 7a7 ,9 g5]al ,any retail] t /ocks oral bir? control = r\t9e1 daily use t is approv$ by1 or o!rwise legally m>ket$ "u regulation by1 ! ,food & ,drug ,adm9i/ration = use )\t a prescription may n int]f]e ) an individual's access to or pur*ase ( su* bir? control or access to m$ically accurate1 compreh5sive in=mation ab\t su* bir? control4 7b7 ,limitation ,no?+ 9 ?is section %all prohibit a retail] t /ocks oral bir? control = r\t9e1 daily use f refus+ to provide an individual ) su* oral bir? control t is approv$ by1 or o!rwise legally m>ket$ "u regulation by1 ! ,food & ,drug ,adm9i/ration if ! individual is unable to pay = ! bir? control1 directly or ?r\gh insurance cov]age4