,,ii  #aaf? ,,congress  #b;d ,session   
,s4 #cede  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,m>* #ai1 #bjbj,mr4    
,cruz 7= himself1 ,mr4 ,lee1 & ,mr4     
,braun7 introduc$ ! foll[+ bill2 :i* 0  
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act to provide =    
reciprocal m>ket+ approval ( c]ta9      
drugs1 biological products1 & devices t 
are au?oriz$ to be lawfully m>ket$      
abroad1 & = o!r purposes4  #a4 ,%ort    
title ,?is ,act may be cit$ z !         
,reciprocity ,ensures ,/reaml9$ ,use (  
,lifesav+ ,treatm5ts = ,coronavirus     
,pati5ts ,act ( #bjbj4  #b4 ,reciprocal 
m>ket+ approval = c]ta9 drugs1          
biological products1 & devices ,! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act is am5d$
 by ins]t+ aft] section #ebd;,a ( su*   
,act 7#ba ,u4,s4,c4 #cfjn-#a7 ! foll[+3 
#ebd;,b4 ,reciprocal m>ket+ approval    
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 or cle>ance is 9 effect 
"u section #eje7;c71 #eaj7k71 or #eae ( 
?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 au?oriz$ to be lawfully
 m>ket$ 9 "o or m ( ! c\ntries includ$ 9
 ! li/ "u section #hjb7;b77#a7 = !      
treatm5t or prev5tion ! coronavirus or  
ano!r disease ( epidemic pot5tial2  7,b7
 abs5t reciprocal m>ket+ approval1 !    
cov]$ product is n approv$ or cle>$ =   
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* approval or cle>ance2 

7,d7 ! au?orization to m>ket ! cov]$    
product 9 "o or m ( ! c\ntries includ$ 9
 ! li/ "u section #hjb7;b77#a7 has n1   
because ( any conc]n relat+ to ! safety 
or effectiv5ess ( ! cov]$ product1 be5  
resc9d$ or )drawn2  7,e7 ! cov]$ product
 is n a bann$ device "u section #eaf2 & 
7,f7 !re is a public heal? or unmet     
m$ical ne$ = ! cov]$ product 9 ! ,unit$ 
,/ates4  7c7 ,safety & effectiv5ess     
7#a7 ,9 g5]al ,! ,secret>y-- 7,a7 may   
decl9e to grant reciprocal m>ket+       
approval "u ?is section ) respect to a  
cov]$ product if ! ,secret>y            
affirmatively det]m9es t ! cov]$        
product-- 7i7 is a drug t is n safe &   
effective2 or  7ii7 is a device = :i*   
!re is no reasonable assurance ( safety 
& effectiv5ess2 &  7,b7 may condition   
reciprocal m>ket+ approval "u ?is       
section on ! conduct ( specifi$ po/m>ket
 /udies1 :i* may include su* /udies     
pursuant to a risk evaluation &         
mitigation /rategy "u section #eje-a4   
7#b7 ,report to ,congress ,^u decl9+ to 

grant reciprocal m>ket+ approval "u ?is 
section ) respect to a cov]$ product1 ! 
,secret>y %all-- 7,a7 include ! d5ial 9 
a li/ ( su* d5ials = ea* mon?2 &  7,b7 n
 lat] ?an ! end ( ! respective mon?1    
submit ! li/ to ! ,committee on ,en]gy &
 ,comm]ce ( ! ,h\se ( ,repres5tatives & 
! ,committee on ,heal?1 ,education1     
,labor1 & ,p5sions ( ! ,s5ate4  7d7     
,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 deems necess>y  
to det]m9e :e!r ! crit]ia li/$ 9        
subsection 7b77#b7 are met2 &  7#b7     
include1 ) respect to ea* c\ntry includ$
 9 ! li/ "u section #hjb7;b77#a7 :]e !  
cov]$ product is au?oriz$ to be lawfully
 m>ket$1 z describ$ 9 subsection        
7b77#b77;,a71 an ,engli% translation ( !
 dossi] issu$ by su* c\ntry to au?orize 
su* m>ket+4  7e7 ,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 ,an ord] issu$ "u ?is          
subsection %all take effect subject to  
,congressional disapproval "u subsection
 7g74  7f7 ,label+2 device              
classification ,dur+ ! #cj-;day p]iod   
describ$ 9 subsection 7e7-- 7#a7 !      
,secret>y & ! sponsor ( ! cov]$ product 
%all exp$iti\sly negotiate & f9alize !  
=m & cont5t ( ! label+ = a cov]$ product
 = :i* reciprocal m>ket+ approval is to 
be grant$2 &  7#b7 9 ! case ( a device =
 :i* reciprocal m>ket+ approval is to be
 grant$1 ! ,secret>y %all-- 7,a7        
classify ! device pursuant to section   
#eac2 &  7,b7 det]m9e :e!r1 abs5t       
reciprocal m>ket+ approval1 ! device    
w\ld ne$ to be cle>$ pursuant to section
 #eaj7k7 or approv$ pursuant to section 
#eae to be lawfully m>ket$ "u ?is ,act4 
7g7 ,congressional disapproval ( ,,fda  
ord]s  7#a7 ,9 g5]al ,a decision ( !    
,secret>y to decl9e to grant reciprocal 
m>ket+ approval "u ?is section %all n   

take effect if a jo9t resolution (      
disapproval ( ! decision is enact$4     
7#b7 ,proc$ure  7,a7 ,9 g5]al ,subject  
to subp>agraph 7,b71 ! proc$ures        
describ$ 9 subsections 7b7 ?r\gh 7g7 (  
section #hjb ( title #e1 ,unit$ ,/ates  
,code1 %all apply to ! consid]ation ( a 
jo9t resolution "u ?is subsection4  7,b7
 ,t]ms ,= purposes ( ?is subsection--   
7i7 ! ref]5ce to section #hja7;a77#a7 9 
section #hjb7;b77#b77;,a7 ( title #e1   
,unit$ ,/ates ,code1 %all be consid]$ to
 ref] to subsection 7c77#b72 &  7ii7 !  
ref]5ce to section #hja7;a77#a77;,a7 9  
section #hjb7;e77#b7 ( title #e1 ,unit$ 
,/ates ,code1 %all be consid]$ to ref]  
to subsection 7c77#b74  7#c7 ,effect (  
,congressional disapproval ,reciprocal  
m>ket+ approval "u ?is section ) respect
 to ! applicable cov]$ product %all take
 effect ^u enactm5t ( a jo9t resolution 
( disapproval "u ?is subsection4  7h7   
,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 or cle>ance ( an         
application or prem>ket notification "u 
section #eje7;c71 #eaj7k71 or #eae ( ?is
 ,act or section #cea7;a7 ( ! ,public   
,heal? ,s]vice ,act1 z applicable1 is 9 
effect4  7i7 ,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 or  
cle>ance "u section #eje7;c71 #eaj7k71  
or #eae ( ?is ,act or section #cea7;a7 (
 ! ,public ,heal? ,s]vice ,act1 z       
applicable4  7j7 ,outrea* ,! ,secret>y  
%all conduct an outrea* campaign to     
enc\rage ! sponsors ( cov]$ products t  
are pot5tially eligible = reciprocal    
m>ket+ approval to reque/ su* approval4 
7k7 ,def9itions ,9 ?is section-- 7#a7 ! 
t]m coronavirus means ,,s>s-,co,v-#b1   
,,covid-#ai1 or ano!r coronavirus )     
epidemic pot5tial2 &  7#b7 ! t]m cov]$  

product means a drug1 biological        
product1 or device t is int5d$ to treat 
or prev5t ! coronavirus or ano!r disease
 ) epidemic pot5tial4  4