,,ii  #aagth ,,congress  #ast ,session  
,s4 #bihc  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,october #g1   
#bjba,mr4 ,braun introduced the         
following bill2 which was read twice and
 referred to the ,committee on ,health1 
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to provide for an accelerated  
approval pathway for certain drugs that 
are authorized to be lawfully marketed  
in other countries4  #a4 ,short title   
,this ,act may be cited as the          
,accelerated ,drug ,approval for        
,prescription ,therapies for            
,coronavirus ,act or the ,,adapt for    
,,covid ,act4  #b4 ,accelerated approval
 of certain drugs that are authorized to
 be lawfully marketed in other countries
 ,chapter ,v of the ,federal ,food1     
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cea et seq47 is amended by inserting  
after section #ejf the following3       
#ejf-a4 ,accelerated approval of certain
 drugs that are authorized to be        
lawfully marketed in other countries    

7a7 ,in general ,the ,secretary may     
approve an application for approval for 
a drug under subsection 7c7 or 7j7 of   
section #eje that is currently          
authorized to be marketed in one or more
 of the countries included in the list  
under section #hjb7;b77#a71 upon a      
determination by the ,secretary that the
 sponsor has submitted evidence         
sufficient to demonstrate all of the    
criteria under subsection 7b77#a74  7b7 
,criteria  7#a7 ,in general ,the        
,secretary may approve a drug under     
subsection 7a7 only if the ,secretary   
determines that there is evidence that--
 7,a7 at the time of application1 the   
drug is authorized to be marketed in a  
country included in the list under      
section #hjb7;b77#a72  7,b7 the drug is 
safe and clinically effective2  7,c7 the
 manufacturer is capable of             
manufacturing the drug safely and       
consistently1 and can assure the safety 
of the supply chain outside the ,united 
,states2  7,d7 all relevant ,united     

,states patents or legal exclusivities  
are expired2  7,e7 absent reciprocal    
marketing approval1 the drug is not     
approved for marketing in the ,united   
,states2  7,f7 the ,secretary has not1  
because of any concern relating to      
safety or effectiveness1 rescinded or   
withdrawn any such approval2 and  7,g7  
the drug is intended for the treatment  
or prevention of coronavirus or another 
disease of epidemic potential4  7#b7    
,limitation ,approval of a drug under   
this section may1 as the ,secretary     
determines appropriate1 be subject to #a
 or both of the following requirements3 
7,a7 ,the sponsor shall conduct         
appropriate postapproval studies to     
verify and describe the predicted effect
 on irreversible morbidity or mortality 
or other clinical benefit of the drug4  
7,b7 ,the sponsor shall submit copies of
 all promotional materials related to   
the product during the preapproval      
review period and1 following approval   
and for such period thereafter as the   

,secretary determines to be appropriate1
 at least #cj days prior to             
dissemination of the materials4  7c7    
,timeline ,the ,secretary shall make a  
determination on an application         
described in subsection 7a7 not later   
than #ahj days after the date of        
submission of such application4  7d7    
,definition ,in this section1 the term  
coronavirus means ,,sars-,co,v-#b1      
,,covid-#ai1 or another coronavirus4  4