,,ii  #aaith ,,congress  #b;d ,session  
,s4 #dcbg  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,april #af     
7legislative day1 ,april #ad71 #bjbf,mr4
 ,cotton introduced the following bill2 
which was read twice and referred to the
 ,committee on ,health1 ,education1     
,labor1 and ,pensions  ,a ,,bill  ,to   
require regulatory review of            
pharmaceutical products from ,chinese   
entities1 and for other purposes4  #a4  
,short title ,this ,act may be cited as 
the ,securing ,america's ,drug ,supply  
from ,communist ,china ,act4  #b4       
,regulatory review of pharmaceutical    
products from ,chinese entities  7a7    
,definitions ,in this section3 7#a7     
,chinese entity ,the term ,chinese      
entity means an entity organized under  
the laws of the ,people's ,republic of  
,china or otherwise subject to the      
jurisdiction of the ,government of the  
,people's ,republic of ,china4  7#b7    
,drug application ,the term drug        
application means an application        

submitted under subsection 7b7 or 7j7 of
 section #eje of the ,federal ,food1    
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee7 or subsection 7a7 or 7k7 of      
section #cea of the ,public ,health     
,service ,act 7#db ,u4,s4,c4 #bfb74     
7#c7 ,,prc-1 ,,ccp-1 or ,,pla-affiliated
 entity  7,a7 ,in general ,the term     
,,prc-1 ,,ccp-1 or ,,pla-affiliated     
entity means any entity that receives   
support directly or indirectly from the 
,government of the ,people's ,republic  
of ,china1 the ,chinese ,communist      
,party1 or the ,people's ,liberation    
,army1 including-- 7i7 an entity owned  
or controlled by the ,government of the 
,people's ,republic of ,china or an     
entity owned or controlled by such an   
entity2 and  7ii7 an entity that has on 
its board of directors one or more      
individuals described in subparagraph   
7,b7 who collectively hold an ownership 
interest in the entity4  7,b7           
,individuals described ,an individual   
described in this subparagraph is-- 7i7 

an official of the ,government of the   
,people's ,republic of ,china1 the      
,chinese ,communist ,party1 or the      
,people's ,liberation ,army2 or  7ii7 an
 executive officer of an entity owned or
 controlled by the ,government of the   
,people's ,republic of ,china1 including
 the president or vice president of1 or 
any other executive officer who performs
 a policy-making function for1 the      
entity4  7#d7 ,secretary ,the term      
,secretary means the ,secretary of      
,health and ,human ,services1 acting    
through the ,commissioner of ,food and  
,drugs4  7b7 ,review of certain new drug
 applications submitted on or after     
enactment  7#a7 ,in general ,the        
,secretary1 in coordination with the    
,office of ,national ,security of the   
,department of ,health and ,human       
,services1 shall review each drug       
application submitted on or after the   
date of enactment of this ,act by a     
sponsor that is a ,chinese entity1 or an
 entity licensing a product owned by a  

,chinese entity1 to determine whether   
such sponsor is a ,,prc-1 ,,ccp-1 or    
,,pla-affiliated entity4 ,in carrying   
out this paragraph1 the ,secretary may  
review any ,drug ,master ,file          
referenced by such an application4  7#b7
 ,denied approval of certain            
applications ,the ,secretary shall not  
approve any drug application submitted  
on or after the date of enactment of    
this ,act if the ,secretary has         
determined under paragraph 7#a7 that the
 sponsor of such application is a       
,,prc-1 ,,ccp-1 or ,,pla-affiliated     
entity4  7c7 ,review of certain new drug
 applications submitted prior to        
enactment  7#a7 ,in general ,the        
,secretary1 in coordination with the    
,office of ,national ,security of the   
,department of ,health and ,human       
,services1 shall review each drug       
application submitted during the period 
described in paragraph 7#b7 to determine
 whether the sponsor of the application 
and1 if applicable1 the holder of the   

approved application1 is a ,,prc-1      
,,ccp-1 or ,,pla-affiliated entity4 ,in 
carrying out this paragraph1 the        
,secretary may review any ,drug ,master 
,file referenced by such an application4
  7#b7 ,period described ,the period    
described in this paragraph is the      
period beginning on ,january #a1 #bjaf1 
and ending on the day before the date of
 enactment of this ,act4  7d7 ,refusal  
of certain drugs offered for import     
7#a7 ,in general ,section #hja of the   
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cha7 is amended by 
adding at the end the following2  7v7   
,import of drugs sponsored by ,,prc-1   
,,ccp-1 and ,,pla-,affiliated entities  
7#a7 ,in general ,the ,secretary shall  
furnish to the ,commissioner of ,u4,s4  
,customs and ,border ,protection a list 
of drugs for which the sponsor or holder
 of an approved application is          
determined under section #b7;c7 of the  
,securing ,america's ,drug ,supply from 
,communist ,china ,act to be a ,,prc-1  

,,ccp-1 or ,,pla-affiliated entity4     
7#b7  ,refusal  ,if it appears that a   
drug imported or offered for import into
 the ,united ,states is a drug for which
 the sponsor or holder of an approved   
application is determined under section 
#b7;c7 of the ,securing ,america's ,drug
 ,supply from ,communist ,china ,act to 
be a ,,prc-1 ,,ccp-1 or ,,pla-affiliated
 entity1 then such drug shall be        
refused1 except as provided in          
paragraphs 7#c7 and 7#d71 and the       
,commissioner of ,u4,s4 ,customs and    
,border ,protection shall destroy1      
without the opportunity for export1 such
 drug4  7#c7  ,compliance  7,a7  ,in    
general  ,the ,secretary shall establish
 a process under which the sponsor of a 
drug described in paragraph 7#b7 or the 
holder of an approved application for   
such a drug1 as applicable1 may--  7i7  
demonstrate to the ,secretary that it is
 no longer a ,,prc-1 ,,ccp-1 or         
,,pla-affiliated entity2 or  7ii7 within
 #ahj days1 sell the approved           

application for such drug to an entity  
that is not a ,,prc-1 ,,ccp-1 or        
,,pla-affiliated entity4  7,b7          
,requirement  ,the process established  
under subparagraph 7,a7 shall include   
the opportunity to appear before the    
,secretary and introduce testimony4     
7,c7  ,notification  ,if the ,secretary 
is satisfied with the action taken under
 clause 7i7 or 7ii7 of subparagraph     
7,a71 the ,secretary shall notify the   
,commissioner of ,u4,s4 ,customs and    
,border ,protection4  7#d7  ,waiver     
,the ,commissioner of ,u4,s4 ,customs   
and ,border ,protection may waive the   
requirements of paragraph 7#b7 and      
authorize the import of a drug described
 in such paragraph if the ,secretary has
 determined that the refusal of the     
import would create or exacerbate a drug
 shortage in the ,united ,states4  7#e7 
,definition of ,,prc-1 ,,ccp-1 or       
,,pla-affiliated entity  ,in this       
subsection1 the term ,,prc-1 ,,ccp-1 or 
,,pla-affiliated entity has the meaning 

given such term in section #b7;a7 of the
 ,securing ,america's ,drug ,supply from
 ,communist ,china ,act4  4  7e7        
,authorization of ,appropriations ,there
 is authorized to be appropriated to    
carry out this section and the          
amendments made by this section         
#e1jjj1jjj1 to remain available until   
expended4