,i  #aag? ,,congress  #b;d ,session  ,h4
 ,r4 #fgjb  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,febru>y #i1          
#bjbb,mrs4 ,walorski 7= h]self1 ,mr4    
,mc,kinley1 ,mr4 ,long1 ,mr4 ,duncan1   
,mr4 ,banks1 ,mr4 ,mooney1 ,mr4         
,lamborn1 ,mr4 ,curtis1 ,mr4 ,hudson1   
,mr4 ,ellzey1 ,mr4 ,bab91 ,mrs4         
,mill]-,meeks1 ,ms4 ,foxx1 ,mr4         
,bur*ett1 ,mr4 ,burgess1 ,mr4 ,fe5/ra1  
,mr4 ,joyce ( ,p5nsylvania1 ,mr4        
,la,malfa1 ,mr4 ,c4 ,scott ,frankl9 (   
,florida1 ,mrs4 ,fis*ba*1 & ,mr4        
,luetkemey]7 introduc$ ! foll[+ bill2   
:i* 0 ref]r$ to ! ,committee on ,en]gy &
 ,comm]ce  ,a ,,bill  ,to require m     
accurate report+ ( abortion drug        
prescrib+ & relat$ adv]se ev5ts1 & = o!r
 purposes4  #a4 ,%ort title ,?is ,act   
may be cit$ z ! ,safegu>d+ ,wom5's &    
,*ildr5's ,heal? ,act ( #bjbb4  #b4     
,f9d+s ,! ,congress f9ds ! foll[+3 7#a7 
,_m data limitations affect ! accuracy (
 /ati/ics relat$ to *emical abortions 9 
! ,unit$ ,/ates1 & !re is no c5tral     

database track+ ?is in=mation4  7#b7    
,/ates may volunt>ily *oose to %>e      
abortion data ) ! ,c5t]s = ,disease     
,control & ,prev5tion 7,,cdc71 b !      
,guttma*] ,in/itute1 :i* directly       
surveys abortion provid]s1 consi/5tly   
docum5ts #cj to #dj p]c5t m abortions   
?an ! ,,cdc4  7#c7 ,"s ,/ates ) high    
volumes ( abortion1 su* z ,cali=nia1 d n
 report to ! ,,cdc4  7#d7 ,only #bh     
,/ates require abortion provid]s to     
report complications1 b !re is r>ely an 
en=c$ p5alty = noncompliance4 ,only #ab 
,/ates require o!r physicians1 coron]s1 
or em]g5cy rooms to report complications
 or dea?s = inve/igation1 & frequ5tly ^!
 facilities & physicians are unaw>e ( ^!
 report+ requirem5ts4  7#e7 ,^! data    
problems are a significant limitation to
 ,unit$ ,/ates /udies on abortion       
complications4  7#f7 ,wom5 exp]i5c+     
complications w (t5 pres5t to an em]g5cy
 room r ?an return to ! abortion        
provid]1 & rese>*]s frequ5tly ignore !  
difficulty 9 obta9+ accurate            

,int]national ,classification (         
,diseases cod+ 9 em]g5cy rooms due to   
se>* eng9e failure to discov] induc$    
abortion codes1 :i* leads to miscod+ &  
frequ5tly attribut+ induc$ abortion     
complications to spontane\s abortions4  
7#g7 ,:5 comp>$ to surgical abortions1  
*emical abortions are ov] #ej p]c5t m   
likely to result 9 an abortion-relat$   
visit to an em]g5cy room1 & by #bjae1   
#fj p]c5t ( *emical abortion-relat$     
em]g5cy room visits 7 incorrectly cod$ z
 misc>riages4  7#h7 ,bett] quality1     
int]national records-l9kages /udies1 &  
meta-analyses docum5t f> high] rates (  
complications & mortality f abortion1   
ca/+ d\bt on ! validity ( ! report$ data
 by :i* ,unit$ ,/ates public heal?      
decisions are made4  7#i7 ,indep5d5t    
sy/ematic analysis ( adv]se ev5t reports
 submitt$ to ! ,food & ,drug            
,adm9i/ration 7,,fda7 betwe5 #bjjj &    
#bjai reveal$ approximately #c1jjj      
,unit$ ,/ates adv]se ev5ts out ( an     
expect$ #ahe1jjj adv]se ev5ts bas$ on ! 

kn[n & publi%$ complication rate aft]   
mifepri/one misopro/ol abortions4 ,?us1 
! ,adv]se ,ev5t ,report+ ,sy/em ( !     
,,fda captur$ only #a4g p]c5t ( ! actual
 adv]se ev5ts occurr+ 9 ,unit$ ,/ates   
wom51 ! majority ( :i* occurr$ prior to 
#bjaf :5 mifepri/one prescrib]s 7       
requir$ to report adv]se ev5ts z "p ( ! 
risk evaluation & mitigation /rategy4   
7#aj7 ,9 #bjaf1 ! ,,fda relax$ !        
ge/ational age disp5s+ f a limitation ( 
#g weeks ge/ation to a limitation ( #aj 
weeks ge/ation1 & at ! same "t ! ,,fda  
no long] requir$ mifepri/one prescrib]s 
to report adv]se ev5ts o!r ?an dea?4 ,^!
 simultane\s *anges ensur$ t !re w\ld be
 no way to capture ! increas$ adv]se    
ev5ts result+ f ! relaxation ( !        
ge/ational age requirem5ts4  7#aa7 ,9   
ord] to fulfil ! /atutory requirem5t ( !
 ,,fda to ov]see & evaluate ! safety (  
mifepri/one use z an abortifaci5t1      
sub/antial *anges 9 ! adv]se ev5t       
report+ = mifepri/one mu/ be implem5t$  
to obta9 an accurate evaluation ( !     

impact ( mifepri/one-relat$ adv]se ev5ts
 on ,unit$ ,/ates wom54  #c4 ,accurate  
report+ on *emical abortion & relat$    
adv]se ev5ts  7a7 ,report+ requirem5ts  
,! ,secret>y ( ,heal? & ,human ,s]vices1
 act+ ?r\gh ! ,commission] ( ,food &    
,drugs1 %all require any abortion drug1 
includ+ any abortion drug approv$ by !  
,food & ,drug ,adm9i/ration be=e ! date 
( enactm5t ( ?is ,act1 to h a risk      
evaluation & mitigation /rategy requir+ 
t-- 7#a7 )9 #ae days ( becom+ aw>e ( any
 dea? or o!r adv]se ev5t 9 a pati5t     
associat$ ) ! use ( su* abortion drug1 a
 heal? c>e provid] %all-- 7,a7 report   
su* dea? or adv]se ev5t to ! ,food &    
,drug ,adm9i/ration & to ! manufactur] (
 su* abortion drug2 &  7,b7 id5tify 9   
su* report+ ! pati5t by a nonid5tifiable
 ref]5ce & ! s]ial numb] f ea* package (
 su* abortion drug if available2 &  7#b7
 a heal? c>e practition] :o prescribes1 
disp5ses1 or adm9i/]s su* abortion drug 
%all-- 7,a7 )9 #ae days ( su* prescrib+1
 disp5s+1 or adm9i/]+1 report ! action  

to ! ,food & ,drug ,adm9i/ration & !    
,c5t]s = ,disease ,control & ,prev5tion2
 &  7,b7 exclude f su* report+ any      
individually id5tifiable pati5t         
in=mation4  7b7 ,portals ,! ,secret>y ( 
,heal? & ,human ,s]vices1 act+ ?r\gh !  
,commission] ( ,food & ,drugs1 %all--   
7#a7 e/abli% & ma9ta9 an onl9e portal t 
all[s heal? c>e practition]s to easily1 
confid5tially1 & securely report to !   
,food & ,drug ,adm9i/ration & ! ,c5t]s =
 ,disease ,control & ,prev5tion by means
 ( onl9e transmission ! in=mation       
requir$ by subsection 7a7 to be report$2
 &  7#b7 e/abli% & ma9ta9 an onl9e      
portal t all[s pati5ts to easily1       
confid5tially1 & securely self-report to
 ! ,food & ,drug ,adm9i/ration & !      
,c5t]s = ,disease ,control & ,prev5tion 
by means ( onl9e transmission any adv]se
 ev5ts ! pati5ts h exp]i5c$ t are       
associat$ ) use ( an abortion drug4  7c7
 ,def9itions ,9 ?is section3 7#a7 ,! t]m
 abortion drug means any drug1 sub/ance1
 or comb9ation ( drugs or sub/ances t is

 int5d$ = use or t is 9 fact us$        
7irrespective ( h[ ! product is         
label$7-- 7,a7 to int5tionally kill !   
unborn *ild ( a woman kn[n to be        
pregnant2 or  7,b7 to int5tionally      
t]m9ate ! pregnancy ( a woman kn[n to be
 pregnant1 ) an int5tion o!r ?an-- 7i7  
to produce a live bir?2  7ii7 to remove 
a dead unborn *ild2 or  7iii7 to treat  
an ectopic or mol> pregnancy4  7#b7 ,!  
t]m adv]se ev5t means any unt[>d m$ical 
occurr5ce associat$ ) ! use ( a drug 9  
humans1 :e!r or n consid]$ drug-relat$4 
7#c7 ,! t]m unborn *ild means an        
individual organism ( ! species homo    
sapi5s1 beg9n+ at f]tilization1 until ! 
po9t ( be+ born alive z def9$ 9 section 
#h7;b7 ( title #a1 ,unit$ ,/ates ,code4 
#d4 ,improv$ report+ ( data relat$ to   
*emical abortions ,! ,public ,heal?     
,s]vice ,act is am5d$ by ins]t+ aft]    
section #cag,u ( su* ,act 7#db ,u4,s4,c4
 #bdg;b-#bc7 ! foll[+3  #cag,v4 ,improv$
 report+ ( data relat$ to *emical       
abortions  7a7 ,9 g5]al ,! ,secret>y1   

act+ ?r\gh ! ,director ( ! ,c5t]s =     
,disease ,control & ,prev5tion1 %all--  
7#a7 collect & aggregate 9 a /&>diz$    
=mat in=mation t is report$ pursuant to 
section #c ( ! ,safegu>d+ ,wom5's &     
,*ildr5's ,heal? ,act ( #bjbb ) respect 
to abortion drugs2  7#b7 make su*       
in=mation available 9 accordance )      
section #eeb ( title #e1 ,unit$ ,/ates  
,code2 &  7#c7 annually publi%-- 7,a7 ! 
numb] ( abortion drugs prescrib$ 9 !    
,unit$ ,/ates2  7,b7 ! numb] ( abortion 
drugs t are %ipp$ directly to prescrib]s
 & to pati5ts2  7,c7 ! total numb] (    
dea?s t occurr$ )9 #abj days ( +e/ion ( 
an abortion drug1 reg>dless ( causal    
attribution1 & ! cause ( dea?2  7,d7 !  
total numb] ( s]i\s adv]se ev5ts t      
occurr$ )9 #abj days ( +e/ion ( an      
abortion drug2  7,e7 ! numb] ( times ea*
 su* s]i\s adv]se ev5t occurr$2  7,f7 ! 
total numb] ( all adv]se ev5ts t occurr$
 )9 #abj days ( +e/ion ( an abortion    
drug1 /ratifi$ by ! ,common ,t]m9ology =
 ,cod+ ,adv]se ,ev5ts 7or any successor 

publication7 crit]ia = sev]ity grad+2 & 
7,g7 ! numb] ( times abortion drug      
+e/ion result$ 9 an incomplete abortion4
  7b7 ,te*nical assi/ance ,! ,secret>y  
%all provide te*nical assi/ance to      
facilitate & improve ! report+ ( data = 
purposes ( ?is section4  7c7 ,annual    
report+ ,! ,secret>y %all-- 7#a7        
annually publi% a report on ! data      
collect$ & aggregat$ pursuant to        
subsection 7a77#a72 &  7#b7 po/ su*     
report on ! public website ( ! ,food &  
,drug ,adm9i/ration4  7d7 ,def9itions ,9
 ?is section3 7#a7 ,! t]m abortion drug 
means any drug1 sub/ance1 or comb9ation 
( drugs or sub/ances t is int5d$ = use  
or t is 9 fact us$ 7irrespective ( h[ ! 
product is label$7-- 7,a7 to            
int5tionally kill ! unborn *ild ( a     
woman kn[n to be pregnant2 or  7,b7 to  
int5tionally t]m9ate ! pregnancy ( a    
woman kn[n to be pregnant1 ) an int5tion
 o!r ?an-- 7i7 to produce a live bir?2  
7ii7 to remove a dead unborn *ild2 or   
7iii7 to treat an ectopic or mol>       

pregnancy4  7#b7 ,! t]m adv]se ev5t     
means any unt[>d m$ical occurr5ce       
associat$ ) ! use ( a drug 9 humans1    
:e!r or n consid]$ drug-relat$4  7#c7 ,!
 t]m s]i\s adv]se ev5t means an adv]se  
ev5t t meets ,common ,t]m9ology = ,cod+ 
,adv]se ,ev5ts crit]ia 7or any successor
 publication7 = level #c or above4  7#d7
 ,! t]m unborn *ild means an individual 
organism ( ! species homo sapi5s1 beg9n+
 at f]tilization1 until ! po9t ( be+    
born alive z def9$ 9 section #h7;b7 (   
title #a1 ,unit$ ,/ates ,code4  4