,i  #aai? ,,congress  #b;d ,session  ,h4
 ,r4 #giec  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,m>* #ag1 #bjbf,mr4   
,sessions 7= himself & ,mr4 ,pet]s7     
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to accel]ate pati5t access to  
innovative m$ic9es & cl9ical trials =   
life-?reat5+ diseases by e/abli%+ a     
reciprocal approval me*anism ) tru/$    
int]national regulatory au?orities4  #a4
 ,%ort title ,?is ,act may be cit$ z !  
,fa/-track+ ,approval = ,innovative ,r>e
 disease !rapies ,act or ! ,,fair ,,act4
  #b4 ,f9d+s ,congress f9ds ! foll[+3   
7#a7 ,pati5ts 9 ! ,unit$ ,/ates (t5 face
 significant delays 9 access+ innovative
 m$ic9es comp>$ to pati5ts 9 o!r tru/$  
nations4  7#b7 ,! l5g?y regulatory      
process at ! ,food & ,drug ,adm9i/ration
 contributes to ! movem5t ( cl9ical     
trials abroad1 lead+ to few]            
opportunities = ,unit$ ,/ates pati5ts to
 p>ticipate 9 cutt+-edge rese>*4  7#c7  
,*9a & o!r nations are rapidly exp&+ _! 

cl9ical trial & bioph>maceutical        
developm5t capacity1 ?reat5+ ,unit$     
,/ates lead]%ip 9 biom$ical innovation4 
7#d7 ,a reciprocal approval me*anism )  
tru/$ int]national regulatory au?orities
 w accel]ate access = ,unit$ ,/ates     
pati5ts to life-sav+ !rapies & pres]ve !
 ,unit$ ,/ates competitive position 9   
biom$ical rese>* & innovation4  #c4     
,reciprocal m>ket+ approval = c]ta9     
drugs ,! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act is am5d$ by ins]t+ aft]  
section #ebd;,b ( su* ,act 7#ba         
,u4,s4,c4 #cfjn-#b7 ! foll[+3  #ebd;,c4 
,reciprocal m>ket+ approval = c]ta9     
drugs  7a7 ,9 g5]al ,a cov]$ product )  
reciprocal m>ket+ approval 9 effect "u  
?is section is deem$ to be subject to an
 application or prem>ket notification = 
:i* an approval is 9 effect "u section  
#eje7;c7 or #eaj7k7 ( ?is ,act or       
section #cea7;a7 ( ! ,public ,heal?     
,s]vice ,act1 z applicable4  7b7        
,eligibility ,! ,secret>y %all1 )       
respect to a cov]$ product1 grant       

reciprocal m>ket+ approval if--  7#a7 ! 
sponsor ( ! cov]$ product submits a     
reque/ = reciprocal m>ket+ approval2 &  
7#b7 ! reque/ demon/rates to !          
,secret>y's satisfaction t--  7,a7 !    
cov]$ product is lawfully m>ket$ 9 a    
=eign c\ntry pursuant to an au?orization
 f a tru/$ int]national regulatory      
au?ority ( t c\ntry2  7,b7 abs5t        
reciprocal m>ket+ approval1 ! cov]$     
product is n approv$ = m>ket+1 z        
describ$ 9 subsection 7a72  7,c7 !      
,secret>y has n1 because ( any conc]n   
relat+ to ! safety or effectiv5ess ( !  
cov]$ product1 resc9d$ or )drawn any su*
 approval2  7,d7 ! au?orization to m>ket
 ! cov]$ product 9 a =eign c\ntry       
pursuant to an au?orization f a tru/$   
int]national regulatory au?ority ( t    
c\ntry has n1 because ( any conc]n      
relat+ to ! safety or effectiv5ess ( !  
cov]$ product1 be5 resc9d$ or )drawn2 & 
7,e7 ! cov]$ product is int5d$ = use 9 !
 diagnosis1 treatm5t1 or mitigation ( an
 imm$iately life-?reat5+ disease or     

condition4  7c7 ,reque/ ,a reque/ =     
reciprocal m>ket+ approval %all--  7#a7 
be 9 su* =m1 be submitt$ 9 su* mann]1 & 
conta9 su* in=mation z ! ,secret>y      
det]m9es necess>y to det]m9e :e!r !     
crit]ia li/$ 9 subsection 7b77#b7 are   
met2 &  7#b7 include1 ) respect to ea*  
tru/$ int]national regulatory au?ority t
 au?oriz$ a cov]$ product to be lawfully
 m>ket$ 9 ! =eign c\ntry involv$1 z     
describ$ 9 subsection 7b77#b77;,a71 an  
,engli% translation 7if necess>y7 ( !   
dossi] issu$ by su* regulatory au?ority 
to au?orize su* m>ket+4  7d7 ,tim+ ,!   
,secret>y %all issue an ord] grant+1 or 
decl9+ to grant1 reciprocal m>ket+      
approval ) respect to a cov]$ product n 
lat] ?an #cj days aft] ! ,secret>y's    
receipt ( a reque/ "u subsection 7b77#a7
 = ! product4  7e7 ,label+2 po/-,m>ket  
requirem5ts ,dur+ ! #cj-;day p]iod      
describ$ 9 subsection 7d71 ! ,secret>y  
%all f9alize--  7#a7 ! =m & cont5t ( !  
label+ = a cov]$ product = :i*          
reciprocal m>ket+ approval is to be     

grant$2 &  7#b7 any po/m>ket /udies !   
,secret>y det]m9es necess>y to ensure ! 
safety & effectiv5ess ( su* product4    
7f7 ,applicability ( relevant provisions
 ,! provisions ( ?is ,act %all apply )  
respect to a cov]$ product = :i*        
reciprocal m>ket+ approval is 9 effect  
to ! same ext5t & 9 ! same mann] z su*  
provisions apply ) respect to a product 
= :i* approval ( an application or      
prem>ket notification "u section        
#eje7;c7 or #eaj7k7 ( ?is ,act or       
section #cea7;a7 ( ! ,public ,heal?     
,s]vice ,act1 z applicable1 is 9 effect4
  7g7 ,)drawal ( reciprocal m>ket+      
approval  7#a7 ,9 g5]al ,! ,secret>y    
may1 at any "t1 )draw or susp5d         
reciprocal m>ket+ approval ) respect to 
a cov]$ product grant$ "u ?is section   
if--  7,a7 new cl9ical or real-_w       
evid5ce demon/rates t ! product pres5ts 
an unreasonable risk ( s]i\s adv]se     
ev5ts or mortality2 or  7,b7 ! tru/$    
int]national regulatory au?ority t      
orig9ally au?oriz$ ! cov]$ product has  

resc9d$ or susp5d$ its approval 9 !     
applicable =eign c\ntry4  7#b7 ,effect (
 )drawal or susp5sion ,if ! )drawal or  
susp5sion "u p>agraph 7#a7 is bas$ on   
adv]se ev5t reports occurr+ )9 ! fir/   
#cj days aft] reciprocal m>ket+         
approval1 ! ,secret>y %all provide      
public notice & may require imm$iate    
cessation ( m>ket+ & di/ribution4  7#c7 
,phase-out option ,! ,secret>y may      
implem5t a phase-out plan = )drawal "u  
p>agraph 7#a71 includ+ pati5t transition
 measures1 to protect public heal? :ile 
m9imiz+ disruption to ongo+ treatm5t4   
7h7  ,fees = reque/  ,= purposes (      
impos+ fees "u *apt] ,,vii1 a reque/ =  
reciprocal m>ket+ approval "u ?is       
section %all be treat$ z an application 
or prem>ket notification = approval "u  
section #eje7;c7 or #eaj7k7 or section  
#cea7;a7 ( ! ,public ,heal? ,s]vice     
,act1 z applicable4  7i7 ,report ,n lat]
 ?an #e ye>s aft] ! date ( enactm5t (   
?is section1 ! ,secret>y %all submit to 
! ,committee on ,en]gy & ,comm]ce & !   

,committee on ,ways & ,means ( ! ,h\se (
 ,repres5tatives & ! ,committee on      
,f9ance & ! ,committee on ,heal?1       
,education1 ,labor1 & ,p5sions ( !      
,s5ate a compreh5sive report on-- 7#a7 !
 effectiv5ess ( ! reciprocal m>ket+     
approval program "u ?is section 9       
accel]at+ access to innovative m$ic9es 9
 ! ,unit$ ,/ates2  7#b7 ! numb] (       
reciprocal m>ket+ approvals ( cov]$     
products grant$ or d5i$ "u ?is section2 
7#c7 ! impact ( ! reciprocal m>ket+     
approval program "u ?is section on      
pati5t safety & adv]se ev5t report+2 &  
7#d7 recomm5dations = ! cont9uation1    
modification1 or t]m9ation ( !          
reciprocal m>ket+ approval program "u   
?is section4  7j7 ,def9itions ,9 ?is    
section3  7#a7 ,cov]$ product ,! t]m    
cov]$ product means a drug1 includ+ a   
biological product 7z def9$ 9 section   
#cea7;i7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bfb7;i7774  7#b7       
,imm$iately life-?reat5+ disease or     
condition ,! t]m imm$iately life-?reat5+

 disease or condition has ! mean+ giv5  
su* t]m 9 section #cab4cjj7;b77#a7 (    
title #ba1 ,code ( ,f$]al ,regulations  
7or successor regulations74  7#c7 ,tru/$
 int]national regulatory au?ority ,! t]m
 tru/$ int]national regulatory au?ority 
means-- 7,a7 ! ,european ,m$ic9es       
,ag5cy2  7,b7 ! ,m$ic9es & ,heal?c>e    
,products ,regulatory ,ag5cy ( ! ,unit$ 
,k+dom2  7,c7 ,heal? ,canada2 &  7,d7   
any o!r int]national regulatory au?ority
 designat$ by ! ,secret>y ( ,heal? &    
,human ,s]vices4  4  #d4 ,reciprocal    
all[ance ( cl9ical inve/igations        
au?oriz$ by tru/$ int]national          
regulatory au?orities ,*apt] ,v ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by
 ins]t+ aft] section #efi;,b 7#ba       
,u4,s4,c4 #cfj;bbb-#h;b7 ! foll[+3      
#efi;,b-#a4 ,reciprocal all[ance (      
cl9ical inve/igations au?oriz$ by tru/$ 
int]national regulatory au?orities  7a7 
,9 g5]al ,a manufactur] may seek        
reciprocal all[ance to conduct a cl9ical

 trial "u section #eje7;i7 ( ?is ,act or
 section #cea7;a77#c7 ( ! ,public ,heal?
 ,s]vice ,act ) respect to a qualifi$   
product by submitt+ an application = su*
 all[ance to ! ,secret>y4  7b7          
,application ,a manufactur] seek+       
reciprocal all[ance "u subsection 7a7 to
 conduct a cl9ical inve/igation z       
describ$ 9 subsection 7a7 %all submit to
 ! ,secret>y an application conta9+--   
7#a7 ! au?orization by a tru/$          
int]national regulatory au?ority to     
conduct ! same cl9ical inve/igation )   
respect to a qualifi$ product 9 !       
applicable =eign c\ntry2 &  7#b7 any    
support+ docum5tation = su*             
au?orization4  7c7 ,treatm5t ,!         
,secret>y %all1 = purposes ( apply+     
section #eje7;i7 ( ?is ,act or section  
#cea7;a77#c7 ( ! ,public ,heal? ,s]vice 
,act-- 7#a7 treat an application =      
reciprocal all[ance ) respect to a      
qualifi$ product "u ?is section z meet+ 
! crit]ia applicable to a submission "u 
section #eje7;i77#b7 ( ?is ,act 7or     

pursuant to section #cea7;a77#c7 ( !    
,public ,heal? ,s]vice ,act7 ) respect  
to beg9n+ a cl9ical inve/igation ( a new
 drug 7or biological product72 &  7#b7  
pursuant to t treatm5t1 issue an ord]   
all[+1 or decl9+ to all[1 a reciprocal  
all[ance ) respect to su* qualifi$      
product n lat] ?an #cj days aft] !      
,secret>y's receipt ( a reque/ "u       
subsection 7b7 = ! product4  7d7        
,applicability ( provisions ,!          
provisions ( section #eje7;i7 ( ?is ,act
 & section #cea7;a77#c7 %all apply )    
respect to an application = reciprocal  
all[ance "u ?is section to ! same ext5t 
& 9 ! same mann] z su* provisions apply 
to an inve/igational new drug           
application "u section #eje7;i7 ( ?is   
,act or section #cea7;a77#c7 ( ! ,public
 ,heal? ,s]vice ,act4  7e7  ,protocol   
modifications  ,! ,secret>y may reque/1 
be=e ! end ( ! #cj-;day p]iod specifi$ 9
 subsection 7c77#b71 t ! manufactur]    
reque/+ a reciprocal all[ance ) respect 
to a cl9ical inve/igation "u ?is section

 modify ! protocols = su* cl9ical       
inve/igation4 ,! ,secret>y %all1 not)/&+
 a reque/ = modification ( protocols "u 
?is subsection1 grant1 or decl9e to     
grant su* reciprocal all[ance )9 su*    
#cj-;day p]iod4  7f7 ,qualifi$ product  
def9$ ,9 ?is section1 ! t]m qualifi$    
product means a cov]$ product 7z def9$ 9
 section #ebd;,b7 t is int5d$ = use 9 ! 
diagnosis1 treatm5t1 or mitigation ( an 
imm$iately life-?reat5+ disease or      
condition4  4