,,ii  #aafth ,,congress  #ast ,session  
,s4 #cacc  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,december #ai1 
#bjai,mr4 ,braun introduced the         
following bill2 which was read twice and
 referred to the ,committee on ,health1 
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to amend the ,federal ,food1   
,drug1 and ,cosmetic ,act to establish a
 time-limited conditional approval      
pathway1 subject to specific            
obligations1 for certain drugs1 and for 
other purposes4  #a4 ,short title ,this 
,act may be cited as the ,conditional   
,approval ,act4  #b4 ,conditional       
approval of new human drugs  7a7 ,in    
general ,subchapter ,a of chapter ,v of 
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cea et seq47 is   
amended by adding at the end of the     
following3  #ebd;,b4 ,conditional and   
time limited approval pathway for new   
drugs  7a7 ,pathway requirements ,the   
,secretary shall1 at the request of the 
sponsor of a new drug1 grant provisional

 and time-limited approval of such drug 
under this section1 if the ,secretary   
determines that--  7#a7 it is likely    
that the sponsor will be able to provide
 comprehensive clinical data after such 
drug is conditionally approved2  7#b7   
such drug is intended for the treatment1
 prevention1 or medical diagnosis of a  
seriously debilitating disease1 a       
life-threatening disease1 or a chronic  
condition2  7#c7 the expected benefits  
of the drug outweigh the potential risks
 to patients1 taking into account the   
fact that additional data are still     
required to assess the drug and the     
severity of the underlying disease or   
condition the drug is intended to treat2
  7#d7 there are no existing meaningful 
treatments for the disease or condition 
that the drug is intended to treat2     
7#e7 confirmatory clinical trials are   
difficult or costly to conduct2 and     
7#f7 such drug is intended to treat a   
disease or condition for which no more  
than #b meaningful treatments currently 

exist4  7b7 ,approval requirements  7#a7
 ,in general ,not later than #ahj days  
after the date on which the ,secretary  
receives a request for conditional      
approval under subsection 7a7 with      
respect to a new drug1 the ,secretary   
shall require the sponsor of such drug  
to--  7,a7 complete in a timely manner  
clinical investigations to provide full 
demonstration of safety and             
effectiveness as described in section   
#eje of the ,federal ,food1 ,drug1 and  
,cosmetic ,act or section #cea of the   
,public ,health ,service ,act1 as       
applicable2  7,b7 conduct clinical      
trials other than confirmatory trials1  
to demonstrate a certain degree of      
safety and efficacy of the drug2 and    
7,c7 demonstrate that necessary         
post-market surveillance and            
risk-management tools are in place with 
respect to the drug4  7#b7 ,period of   
conditional approval ,the period of     
conditional approval for a drug under   
this subsection is effective for #a     

year1 and is renewable by the ,secretary
 for up to #d additional #a-year terms4 
,a conditional approval shall be in     
effect for not more than #e years from  
the date on which conditional approval  
is first granted4  7#c7 ,time limitation
 ,if any conditionally drug approved    
under this section is not brought to    
market within #c years of the           
conditional approval1 any conditional   
approval granted under this section with
 respect to such drug shall be deemed   
invalid4  7#d7 ,requirements ,as a      
condition on receipt of conditional     
approval under this section1 the        
,secretary shall require the sponsor of 
the drug to agree to the following3     
7,a7 ,complete in a timely manner such  
clinical investigations to provide a    
full demonstration of effectiveness as  
the ,secretary determines to be         
necessary for approval of the drug under
 section #eje of this ,act or section   
#cea of the ,public ,health ,service    
,act1 as applicable4  7,b7 ,submit to   

the ,secretary an annual report on the  
progress of the sponsor in conducting   
the clinical investigations required    
under this section4  7,c7 ,ensure that  
all labeling and promotional materials  
for the drug bear the statement         
conditionally approved by the ,,fda     
pending a full demonstration of         
effectiveness under applicable          
7specifying the application number      
assigned by the ,secretary in place of  
the blank74  7#e7 ,applying for full    
approval ,the sponsor of a drug granted 
conditional approval pursuant to this   
subsection may1 at any point1 submit an 
application for full approval as        
described under section #eje of the     
,federal ,food1 ,drug1 and ,cosmetic    
,act or section #cea of the ,public     
,health ,service ,act1 as applicable4   
7#f7 ,utilization of real world evidence
 to support full approval ,the          
,secretary shall allow the use of real  
world evidence1 as defined in section   
#eje;,f7b71 and collected by the sponsor

 of a drug during the duration of       
conditional approval granted approval to
 this subsection1 to supplement an      
application for full approval1 in       
addition to other post-approval studies4
  7c7 ,limitation on liability  7#a7 ,in
 general ,with respect to any claim     
under ,state law alleging that a drug   
sold or otherwise made available        
pursuant to a grant of conditional      
approval under this subsection is unsafe
 or ineffective1 no liability in a cause
 of action shall lie against a sponsor  
or manufacturer1 unless the relevant    
conduct constitutes reckless or willful 
misconduct1 gross negligence1 or an     
intention tort under any applicable     
,state law4  7#b7 ,rule of construction 
,except as set forth in subparagraph    
7,a71 nothing in this subsection shall  
be construed to modify or otherwise     
affect the right of any person to bring 
private action under any ,federal or    
,state product liability1 tort1 consumer
 protection1 or warranty law4  7d7      

,definitions ,in this section3 7#a7     
,seriously debilitating disease ,the    
term severely debilitating disease means
 a disease or condition that causes     
major irreversible morbidity4  7#b7     
,life-threatening disease ,the term     
life-threatening disease means-- 7,a7 a 
disease or condition where the          
likelihood of death is high unless the  
course of the disease is interrupted2 or
  7,b7 a disease or condition with      
potentially fatal outcomes1 where the   
end point of clinical trial analysis is 
survival4  7#c7 ,chronic condition ,the 
term chronic condition means a disease  
or condition that-- 7,a7 usually lasts  
for #c months or longer2 and  7,b7 7i7  
requires ongoing medical attention2 or  
7ii7 limits activities of daily living4 
4  7b7 ,regulations and guidance ,not   
later than #a year after the date of the
 enactment of this ,act1 the ,secretary 
of ,health and ,human ,services shall   
issue final regulations and guidance for
 carrying out section #ebd;,b of the    

,federal ,food1 ,drug1 and ,cosmetic    
,act1 as added by subsection 7a74  7c7  
,conforming amendment ,section #eje7;a7 
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;a77 
is amended by inserting 1 or there is in
 effect a conditional approval under    
section #ebd;,b with respect to such    
drug before the period4