,,ii  #aae? ,,congress  #a/ ,session    
,s4 #ajdh  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,may #d1 #bjag ,mr4    
,hat* 7= himself1 ,mr4 ,b5net1 ,mr4     
,burr1 & ,mr4 ,casey7 introduc$ ! foll[+
 bill2 :i* 0 read twice & ref]r$ to !   
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions  ,a ,,bill  ,to exp& 
pati5t access to exp]im5tal treatm5ts 9 
cl9ical trials1 & = o!r purposes4  #a4  
,%ort title  ,?is ,act may be cit$ z !  
,enhanc$ ,cl9ical ,trial ,design ,act ( 
#bjag4  #b4 ,pati5t access to exp]im5tal
 treatm5ts  7a7 ,public meet+  7#a7 ,9  
g5]al ,! ,secret>y ( ,heal? & ,human    
,s]vices 7ref]r$ to 9 ?is ,act z !      
,secret>y71 act+ ?r\gh ! ,commission] ( 
,food & ,drugs1 9 coord9ation ) !       
,director ( ! ,national ,in/itutes (    
,heal?1 & 9 consultation ) pati5ts1     
heal? c>e provid]s1 drug sponsors1      
bioe?ici/s1 & o!r /akehold]s1 %all1 n   
lat] ?an #ahj days aft] ! date (        
enactm5t ( ?is ,act1 conv5e a public    
meet+ to discuss cl9ical trial inclusion

 & exclusion crit]ia to in=m ! guidance 
"u subsection 7c74 ,! ,secret>y %all    
in=m ! ,comptroll] ,g5]al ( ! ,unit$    
,/ates ( ! date :5 ! public meet+ w take
 place4  7#b7 ,topics ,! ,secret>y %all 
provide a publicly available report on !
 topics discuss$ at ! meet+ describ$ 9  
p>agraph 7#a7 )9 #cj days ( su* meet+4  
,su* topics %all include discussion (-- 
7,a7 ! rationale =1 & pot5tial b>ri]s = 
pati5ts creat$ by1 cl9ical trial        
inclusion & exclusion crit]ia2  7,b7 h[ 
pati5t populations mo/ likely to be     
affect$ by a drug c b5efit f ! results (
 trials t employ alt]native designs1 z  
well z pot5tial risks associat$ )       
alt]native cl9ical trial designs2  7,c7 
b>ri]s to p>ticipation 9 cl9ical trials1
 includ+-- 7i7 in=mation reg>d+ any     
pot5tial risks & b5efits ( p>ticipation2
  7ii7 regulatory1 geographical1 &      
socioeconomic b>ri]s2 &  7iii7 ! impact 
( exclusion crit]ia on ! enrollm5t 9    
cl9ical trials ( infants & *ildr51      
pregnant & lactat+ wom51 s5iors1        

individuals ) advanc$ disease1 &        
individuals ) co-morbid conditions2     
7,d7 cl9ical trial designs & me?ods t   
increase enrollm5t ( m div]se pati5t    
populations :ile facilitat+ ! collection
 ( data to support sub/antial evid5ce ( 
safety & effectiv5ess2 &  7,e7 h[ *anges
 to cl9ical trial inclusion & exclusion 
crit]ia may impact ! complexity ( !     
cl9ical trial design & l5g? ( cl9ical   
trials1 & pot5tial approa*es to mitigat+
 ^? impacts to ensure t ! ability to    
demon/rate safety & effectiv5ess is n   
h9d]$ ?r\gh pot5tial *anges 9           
eligibility crit]ia4  7b7 ,report ,n    
lat] ?an #a ye> aft] ! ,secret>y issues 
a report on ! topics discuss$ at !      
public meet+ "u subsection 7a77#b71 !   
,comptroll] ,g5]al ( ! ,unit$ ,/ates    
%all report to ! ,committee on ,heal?1  
,education1 ,labor1 & ,p5sions ( !      
,s5ate & ! ,committee on ,en]gy &       
,comm]ce ( ! ,h\se ( ,repres5tatives on 
individual access to inve/igational     
drugs ?r\gh ! exp&$ access program "u   

section #efa7;b7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj;bbb7b774 ,! report %all include--  
7#a7 a description ( actions tak5 by    
manufactur]s "u section #efa;,a ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;bbb-#j72  7#b7      
consid]ation ( :e!r ,=m ,,fda #cibf & ! 
guidance docum5t entitl$ ,exp&$ ,access 
to ,inve/igational ,drugs = ,treatm5t   
,use--,que/ions & ,answ]s1 issu$ by !   
,food & ,drug ,adm9i/ration 9 ,june     
#bjaf1 has r$uc$ application burd5 )    
respect to individuals & physicians     
seek+ access to inve/igational new drugs
 pursuant to section #efa7;b7 ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cfj;bbb7 & improv$ cl>ity =  
pati5ts1 physicians1 & drug manufactur]s
 ab\t su* process2  7#c7 consid]ation ( 
:e!r ! guidance or regulations releas$  
or updat$ "u section #efa ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;bbb7 h improv$ access =  
individual pati5ts :o d n qualify =     

cl9ical trials ( su* inve/igational     
drugs1 & :at b>ri]s to su* access rema92
  7#d7 an assessm5t ( h[ pati5ts & heal?
 c>e provid]s navigate diff]5t av5ues to
 engage ) ! ,food & ,drug ,adm9i/ration 
or drug sponsors on exp&$ access2 &     
7#e7 an analysis ( ! ,secret>y's report 
"u subsection 7a77#b74  7c7 ,guidance   
7#a7 ,9 g5]al ,n lat] ?an #ahj days aft]
 ! publication ( ! report "u subsection 
7a7 ! ,secret>y1 act+ ?r\gh !           
,commission] ( ,food & ,drugs1 %all     
issue "o or m draft guidances reg>d+    
eligibility crit]ia = cl9ical trials4 ,n
 lat] ?an #ah mon?s aft] ! public comm5t
 p]iod on ea* su* draft guidance ends1 !
 ,secret>y %all issue a revis$ draft    
guidance or f9al guidance4  7#b7        
,cont5ts ,! guidance docum5ts describ$ 9
 p>agraph 7#a7 %all address             
me?odological approa*es t a manufactur] 
or sponsor ( an inve/igation ( a new    
drug may take to--  7,a7 broad5         
eligibility crit]ia = cl9ical trials1   
especially ) respect to drugs = !       

treatm5t ( s]i\s & life-?reat5+         
conditions or diseases = :i* !re is an  
unmet m$ical ne$2 &  7,b7 develop       
eligibility crit]ia =1 & increase trial 
recruitm5t to1 cl9ical trials s t       
enrollm5t 9 su* trials m accurately     
reflects ! pati5ts mo/ likely to receive
 ! drug1 z applicable & z appropriate1  
:ile support+ f9d+s ( sub/antial evid5ce
 ( safety & effectiv5ess4  #c4 ,improv+ 
in/itutional review bo>d review ( s+le  
pati5t exp&$ access protocol ,n lat] ?an
 #a ye> aft] ! date ( enactm5t ( ?is    
,act1 ! ,secret>y ( ,heal? & ,human     
,s]vices 7ref]r$ to 9 ?is section z !   
,secret>y71 act+ ?r\gh ! ,commission] ( 
,food & ,drugs1 %all issue guidance or  
regulations1 or revise exi/+ guidance or
 regulations1 to /reaml9e ! in/itutional
 review bo>d review = individual        
p$iatric & adult pati5t exp&$ access    
protocol "u #efa7;b7 ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj;bbb7b774 ,su* guidance or          
regulation may include a description ( !

 conditions "u :i* an in/itutional      
review bo>d *air 7or designee7 may      
review individual pati5t exp&$ access   
protocol submitt$ "u section #eje7;i7 ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cee7;i77 = a drug & h[  
c5traliz$ in/itutional review bo>ds may 
facilitate ! use ( exp&$ access         
protocols4 ,! ,secret>y %all update any 
relevant =ms associat$ ) individual     
pati5t exp&$ access protocol z necess>y4
  #d4 ,exp&$ access policy transp>5cy   
,section #efa;,a7f7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj;bbb-#j7;f77 is am5d$-- 7#a7 9 !    
matt] prec$+ p>agraph 7#a71 by /rik+    
lat] & ins]t+ e>li]2  7#b7 by /rik+     
p>agraph 7#a72  7#c7 by r$esignat+      
p>agraph 7#b7 z p>agraph 7#a72  7#d7 9  
p>agraph 7#a7 z s r$esignat$1 by /rik+ !
 p]iod at ! end & ins]t+ 2 or2 &  7#e7  
by add+ at ! end ! foll[+3  7#b7 z      
applicable1 #ae days aft] ! drug        
receives a designation z a break?r\gh   
!rapy1 fa/ track product1 or reg5]ative 

advanc$ !rapy "u subsection 7a71 7b71 or
 7g71 respectively1 ( section #ejf4  4