,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #bdga  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,m>* #bg1 #bjbe,mr4   
,swalwell 7= himself & ,mr4 ,cr5%aw7    
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to update ! ,national ,action  
,plan = ,adv]se ,drug ,ev5t ,prev5tion  
to consid] advances 9 ph>macog5omic     
rese>* & te/+1 to improve electronic    
heal? records = ph>macog5omic in=mation1
 & = o!r purposes4  #a4 ,%ort title ,?is
 ,act may be cit$ z ! ,"r ,drug ,dose   
,n[ ,act ( #bjbe4  #b4 ,table ( cont5ts 
,! table ( cont5ts ( ?is ,act is z      
foll[s3  ,sec4 #a4 ,%ort title4 ,sec4   
#b4 ,table ( cont5ts4 ,sec4 #c4         
,national ,action ,plan = ,adv]se ,drug 
,ev5t ,prev5tion4 ,sec4 #d4 ,adv]se drug
 ev5t & ph>macog5omic te/+ education =  
heal? c>e pr(essionals4 ,sec4 #e4       
,improv+ ,,ehr sy/ems to improve ! use (
 ph>macog5omic in=mation4  #c4 ,national
 ,action ,plan = ,adv]se ,drug ,ev5t    
,prev5tion ,! ,secret>y ( ,heal? &      

,human ,s]vices 79 ?is ,act ref]r$ to z 
! ,secret>y7 %all-- 7#a7 n lat] ?an #ahj
 days aft] ! date ( enactm5t ( ?is ,act1
 9 coord9ation ) ! heads ( o!r relevant 
,f$]al dep>tm5ts & ag5cies1 submit a    
report to ! ,congress on ! implem5tation
 ( ! ,national ,action ,plan = ,adv]se  
,drug ,ev5t ,prev5tion ( ! ,dep>tm5t (  
,heal? & ,human ,s]vices1 includ+ on !  
progress 9 meet+ ! t>get outcomes       
approv$ by ! ,f$]al ,int]ag5cy ,/e]+    
,committee = ,adv]se ,drug ,ev5ts2  7#b7
 conv5e ! ,f$]al ,int]ag5cy ,/e]+       
,committee = ,adv]se ,drug ,ev5ts to    
update ! ,national ,action ,plan =      
,adv]se ,drug ,ev5t ,prev5tion2 &  7#c7 
require su* ,committee1 9 updat+ !      
,national ,action ,plan = ,adv]se ,drug 
,ev5t ,prev5tion--  7,a7 to consid]     
advances 9 sci5tific und]/&+ & te*nology
 p]ta9+ to drug-g5e int]actions 7includ+
 int]actions among multiple drugs &     
g5es71 cl9ical outcomes1 heal? c>e      
utilization1 & ! decreas+ co/ ( g5etic  
te/+2  7,b7 to assess ! role (          

ph>macog5etics te/+ comb9$ ) cl9ical    
decision support z an evid5ce-bas$      
prev5tion tool2 &  7,c7 to evaluate     
op]at+ *>act]i/ics = ,f$]al adv]se drug 
ev5t monitor+ sy/ems & exp& capabilities
 to id5tify g5etic associations 9 adv]se
 ev5ts4  #d4 ,adv]se drug ev5t &        
ph>macog5omic te/+ education = heal? c>e
 pr(essionals ,! ,secret>y %all issue   
guidance = heal? c>e provid]s & heal?   
c>e lead]s1 includ+ adm9i/rators1 prim>y
 & specialty c>e physicians1 ph>maci/s1 
nurse practition]s1 physician assi/ants1
 physician m$ical g5etici/s1 laboratory 
m$ical g5etici/s1 g5etic c\nselors1     
m$ical educators1 & ! faculty ( s*ools (
 m$ic9e & o!r s*ools ( heal? pr(essions1
 on ! foll[+3  7#a7 ,ph>macog5omic te/+ 
& ! ext5t ( its ability to prev5t adv]se
 drug reactions4  7#b7 ,ph>macog5omic   
te/+1 drug int]action al]t+ sy/ems1 :5  
to ref] to or consult ) a g5etics       
provid]1 & ! applicable ,f$]al /&>ds (  
c>e = pati5ts :o are suspect$ or kn[n to
 h a g5etic v>iant t is kn[n to impact  

drug metabolism or adv]se reactions4    
7#c7 ,evid5ce-bas$ in=mation t w\ld     
enc\rage individuals & _! heal? c>e     
pr(essionals to consid] ph>macog5omic   
te/+ z "p ( _! heal? c>e plan to ! ext5t
 appropriate4  7#d7 ,! role ( m$ical    
pr(essionals :o specialize 9 g5etics &  
g5omics4  7#e7 ,h[ to incorporate       
ph>macog5omics into compreh5sive        
m$ication managem5t4  7#f7 ,! importance
 ( report+ in=mation ab\t kn[n &        
relevant ph>macog5omic in=mation :5     
report+ adv]se drug ev5ts to ! ,,fda    
,adv]se ,ev5t ,report+ ,sy/em4  #e4     
,improv+ ,,ehr sy/ems to improve ! use (
 ph>macog5omic in=mation  7a7           
,c]tification crit]ia ,! ,secret>y %all 
provide guidance = heal? c>e provid]s & 
heal? c>e lead]s1 includ+ adm9i/rators1 
prim>y & specialty c>e physicians1      
ph>maci/s1 nurse practition]s1 physician
 assi/ants1 physician m$ical g5etici/s1 
laboratory m$ical g5etici/s1 g5etic     
c\nselors1 m$ical educators1 & ! faculty
 ( s*ools ( m$ic9e & o!r s*ools ( heal? 

pr(essions1 on heal? in=mation          
te*nologies1 includ+ = electronic       
prescrib+ sy/ems & real-"t ph>macy      
b5efit *ecks1 reg>d+ h[1 be=e a         
m$ication ord] is complet$ & act$ ^u    
dur+ comput]iz$ provid] ord] entry1     
int]v5tions might automatically indicate
 to a us]-- 7#a7 :5 ph>macog5omic te/+  
is appropriate bas$ on a drug product's 
label or pe]-review$ pr(essional        
guidel9es2 &  7#b7 drug-g5e &           
drug-drug-g5e associations1 e/abli%$ by 
a drug product's label or pe]-review$   
pr(essional guidel9es1 bas$ on a        
pati5t's m$ication li/1 m$ication all]gy
 li/1 & results f ph>macog5omic te/+4   
7b7 ,guidance on drug-,g5e int]action   
al]t+ sy/ems  7#a7 ,issuance & updates  
,! ,secret>y %all--  7,a7 issue r\t9e   
guidance on drug-g5e int]action al]t+   
sy/ems 9 electronic heal? records2 &    
7,b7 n less ?an biannually1 update su*  
guidance to incorporate ph>macog5omic   
in=mation f--  7i7 new or updat$ drug   
labels2 &  7ii7 newly e/abli%$          

pe]-review$ pr(essional guidel9es on    
drug-g5e associations4  7#b7 ,rule (    
con/ruction ,no?+ 9 p>agraph 7#a7 %all  
be con/ru$ z prohibit+ an entity f      
updat+ ! results ( ph>macog5omic te/+1  
or al]t+ ! provid]1 if a m$ication is   
contra9dicat$ by ! results (            
ph>macog5omic te/+4  7c7 ,r$uc+ adv]se  
drug ev5ts report+ burd5s ,! ,secret>y  
%all enc\rage ! developm5t ( electronic 
heal? record sy/ems t all[ = adv]se drug
 ev5t in=mation to be directly report$  
to ! ,,fda ,adv]se ,ev5t ,report+       
,sy/em4  7d7 ,updat+ ,,fa]s2            
pati5t-,fri5dly report+ ,! ,secret>y    
%all-- 7#a7 update ! ,,fda ,adv]se ,ev5t
 ,report+ ,sy/em1 includ+ to--  7,a7    
create an optional selection tool t     
all[s individuals to report :e!r an     
adv]se drug ev5t is associat$ ) a       
drug-g5e or drug-drug-g5e int]action2 & 
7,b7 accept in=mation directly f heal?  
c>e provid]s' electronic heal? record   
sy/ems2  7#b7 "w ) relevant ,f$]al      
ag5cies & (fices1 & /akehold]s1 to      

create pati5t-fri5dly electronic options
 = report+ adv]se drug ev5ts su* z      
submission ?r\gh an optional designat$  
mobile device application or mobile     
device messag+ application2 &  7#c7 n   
lat] ?an #a ye> aft] ! date ( enactm5t (
 ?is ,act1 report to ! ,congress on !   
progress made 9 implem5t+ p>agraphs 7#a7
 & 7#b74  7e7 ,,gao /udy &              
recomm5dations on inclusion ( in=mation 
on drug-,g5e int]actions on drug labels 
,n lat] ?an #ahj days aft] ! date (     
enactm5t ( ?is ,act1 ! ,comptroll]      
,g5]al ( ! ,unit$ ,/ates %all-- 7#a7    
/udy1 & =mulate recomm5dations on1 h[ ! 
,food & ,drug ,adm9i/ration c include & 
update in=mation on drug-g5e int]actions
 on drug labels2 &  7#b7 submit         
recomm5dations to ! relevant committees 
( jurisdiction4  7f7 ,report on         
additional improvem5ts to electronic    
heal? record sy/ems  7#a7 ,9 g5]al ,n   
lat] ?an #ahj days aft] ! date (        
enactm5t ( ?is ,act1 ! ,secret>y %all-- 
7,a7 complete a report on additional    

improvem5ts to electronic heal? record  
sy/ems t are ne$$ to fur!r ! developm5t 
( real _w evid5ce 7z def9$ 9 section    
#eje;,f ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cee;g77 9
 ph>macog5omics2 &  7,b7 submit su*     
report to ! ,congress4  7#b7            
,consid]ation ( ne$$ advancem5ts ,z "p (
 ! report "u p>agraph 7#a71 ! ,secret>y 
%all consid] :at advancem5ts are ne$$ 9 
electronic heal? record sy/ems to       
capture in=mation ab\t ! laboratory & ! 
te/ us$ z "p ( ph>macog5omic te/+4