,i  #aacth ,,congress  #ast ,session    
,h4 ,r4 #cgdb  ,,in ,,the ,,house ,,of  
,,representatives  ,december #ab1       
#bjac,mr4 ,gingrey of ,georgia 7for     
himself1 ,mr4 ,gene ,green of ,texas1   
,mr4 ,shimkus1 ,ms4 ,eshoo1 ,mr4        
,whitfield1 ,ms4 ,de,gette1 ,mrs4       
,blackburn1 ,mr4 ,engel1 ,mr4 ,griffith 
of ,virginia1 and ,mr4 ,butterfield7    
introduced the following bill2 which was
 referred to the ,committee on ,energy  
and ,commerce  ,a ,,bill  ,to provide   
for approval of certain drugs and       
biological products indicated for use in
 a limited population of patients in    
order to address increases in bacterial 
and fungal resistance to drugs and      
biological products1 and for other      
purposes4  #a4 ,short title ,this ,act  
may be cited as the ,antibiotic         
,development to ,advance ,patient       
,treatment ,act of #bjac4  #b4 ,approval
 of certain drugs for use in a limited  
population of patients  7a7 ,approval of
 certain antibacterial and antifungal   

drugs ,section #eje of the ,federal     
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cee7 is amended by adding at 
the end the following3  7x7 ,approval of
 certain antibacterial and antifungal   
drugs for use in a limited population of
 patients  7#a7 ,approval ,at the       
request of the sponsor of an            
antibacterial or antifungal drug that is
 intended to treat a serious or         
life-threatening disease or condition1  
the ,secretary-- 7,a7 may approve the   
drug under subsection 7c7 to treat a    
limited population of patients for which
 there is an unmet medical need2  7,b7  
in determining whether to grant such    
approval for a limited population of    
patients1 may rely on traditional       
endpoints1 alternative endpoints1 or a  
combination of traditional and          
alternative endpoints2 datasets of      
limited size2 pharmacologic or          
pathophysiologic data2 data from phase  
#b clinical studies2 and such other     
confirmatory evidence as the ,secretary 

deems necessary2 and  7,c7 shall require
 the labeling of drugs approved pursuant
 to this subsection to prominently      
include in the prescribing information  
required by section #bja4eg of title    
#ba1 ,code of ,federal ,regulations 7or 
any successor regulation7 the following 
statement3 ,this drug is indicated for  
use in a limited and specific population
 of patients44  7#b7 ,promotional       
materials ,the provisions of section    
#ejf7;c77#b77;,b7 shall apply with      
respect to approval under this          
subsection to the same extent and in the
 same manner as such provisions apply   
with respect to accelerated approval    
under section #ejf7;c77#a74  7#c7       
,withdrawal of limited population       
approval requirements ,if a drug is     
approved pursuant to this subsection to 
treat a limited population of patients  
and is subsequently approved or licensed
 under this section or section #cea of  
the ,public ,health ,service ,act1      
respectively1 without such a limitation1

 the ,secretary may remove any labeling 
requirements or postmarketing conditions
 made applicable to the drug during the 
earlier approval process4  7#d7         
,relation to other provisions ,nothing  
in this subsection shall be construed to
 prohibit designation and expedited     
review of a drug as a breakthrough      
therapy under section #ejf7;a71         
designation and treatment of a drug as a
 fast track product under section       
#ejf7;b71 or accelerated approval of the
 drug under section #ejf7;c71 in        
combination with approval of the drug   
for use in a limited population of      
patients under this subsection4  7#e7   
,rule of construction ,nothing in this  
subsection shall be construed to alter  
the standards of evidence under         
subsection 7c7 or 7d7 7including the    
substantial evidence standard in        
subsection 7d774 ,subsections 7c7 and   
7d7 and such standards of evidence apply
 to the review and approval of drugs    
under this subsection1 including whether

 a drug is safe and effective4 ,nothing 
in this subsection shall be construed to
 limit the authority of the ,secretary  
to approve products pursuant to this    
,act and the ,public ,health ,service   
,act as authorized prior to the date of 
enactment of this subsection4  7#f7     
,effective immediately ,the ,secretary  
shall have the authorities vested in the
 ,secretary by this subsection beginning
 on the date of enactment of this       
subsection1 irrespective of when and    
whether the ,secretary promulgates final
 regulations to carry out this          
subsection4  4  7b7 ,licensure of       
certain biological products ,section    
#cea7;j7 of the ,public ,health ,service
 ,act 7#db ,u4,s4,c4 #bfb7;j77 is       
amended-- 7#a7 by striking 7j7 and      
inserting 7j77#a72  7#b7 by inserting   
#eje7x71 after #eje7p712 and  7#c7 by   
adding at the end the following3  7#b7  
,in applying section #eje7x7 of the     
,federal ,food1 ,drug1 and ,cosmetic    
,act to the licensure of biological     

products under this section-- 7,a7      
references to an antibacterial or       
antifungal drug that is intended to     
treat a serious or life-threatening     
disease or condition shall be construed 
to refer to biological products intended
 to treat a bacterial or fungal         
infection associated with a serious or  
life-threatening disease2 and  7,b7     
references to approval of a drug under  
section #eje7;c7 of such ,act shall be  
construed to refer to licensure of a    
biological product under subsection 7a7 
of this section4  4  7c7 ,monitoring    
,title ,,iii of the ,public ,health     
,service ,act is amended by inserting   
after section #cag,t 7#db ,u4,s4,c4     
#bdg;b-#bb7 the following3  #cag,u4     
,monitoring antibacterial and antifungal
 drug use and resistance  7a7           
,monitoring ,the ,secretary1 acting     
through the ,director of the ,centers   
for ,disease ,control and ,prevention1  
shall use the ,national ,healthcare     
,safety ,network or another appropriate 

monitoring system to monitor-- 7#a7 the 
use of antibacterial and antifungal     
drugs1 including those receiving        
approval or licensure for a limited     
population pursuant to section #eje7x7  
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act2 and  7#b7 changes in    
bacterial and fungal resistance to      
drugs4  7b7 ,public availability of data
 ,the ,secretary1 acting through the    
,director of the ,centers for ,disease  
,control and ,prevention1 shall make the
 data derived from monitoring under this
 section publicly available for the     
purposes of-- 7#a7 improving the        
monitoring of important trends in       
antibacterial and antifungal resistance2
 and  7#b7 ensuring appropriate         
stewardship of antibacterial and        
antifungal drugs1 including those       
receiving approval or licensure for a   
limited population pursuant to section  
#eje7x7 of the ,federal ,food1 ,drug1   
and ,cosmetic ,act4  4  #c4             
,susceptibility test interpretive       

criteria for microbial organisms  7a7   
,in general ,section #eaa of the        
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cfj;a7 is amended  
to read as follows3  #eaa4              
,susceptibility test interpretive       
criteria for microbial organisms  7a7   
,in general ,the ,secretary shall       
identify upon approval and subsequently 
update susceptibility test interpretive 
criteria for antibacterial drugs        
7including biological products intended 
to treat a bacterial infection and other
 types of antimicrobial drugs1 as deemed
 appropriate by the ,secretary71        
including qualified infectious disease  
products1 by relying upon1 to the extent
 available-- 7#a7 preclinical and       
clinical data1 including                
pharmacokinetic1 pharmacodynamic1 and   
epidemiological data2  7#b7 ,bayesian   
and pharmacometric statistical          
methodologies2 and  7#c7 such other     
confirmatory evidence as the ,secretary 
deems necessary4  7b7 ,responding to    

susceptibility test interpretive        
criteria identified or updated by       
private entities  7#a7 ,in general ,each
 quarter of each fiscal year1 the       
,secretary shall-- 7,a7 evaluate any    
appropriate new or updated              
susceptibility test interpretive        
criteria published by a nationally or   
internationally recognized standard     
development organization2 and  7,b7     
publish on the public ,website of the   
,food and ,drug ,administration a       
notice-- 7i7 adopting the new or updated
 interpretive criteria2  7ii7 declining 
to adopt the new or updated interpretive
 criteria and explaining the reason for 
such decision2 or  7iii7 adopting one or
 more parts of the new or updated       
interpretive criteria1 declining to     
adopt the remainder of such criteria1   
and explaining the reason for so        
declining4  7#b7 ,annual compilation of 
notices ,each year1 the ,secretary shall
 compile the notices published under    
paragraph 7#a77;,b7 and publish such    

compilation in the ,federal ,register4  
7#c7 ,relation to section #ead7;c7 ,any 
susceptibility test interpretive        
criterion for which an approval is in   
effect under paragraph 7#a7 may be      
recognized as a standard by the         
,secretary under section #ead7;c77#a74  
7#d7 ,use of non-adopted criteria       
,nothing in this section prohibits the  
sponsor of a drug or device from seeking
 approval or clearance of the drug or   
device1 or changes to the drug1 the     
device1 or its labeling1 on the basis of
 susceptibility test interpretive       
criteria which differ from those adopted
 pursuant to paragraph 7#a74  7c7       
,definitions ,in this section3 7#a7 ,the
 term qualified infectious disease      
product means a qualified infectious    
disease product designated under        
#eje;,e7d74  7#b7 ,the term             
susceptibility test interpretive        
criteria means one or more specific     
values which characterize the degree to 
which bacteria or other microbes are    

resistant to the drug 7or drugs7 tested1
 such as clinically susceptible1        
intermediate1 or resistant4  4  7b7     
,conforming amendment ,section #aaaa of 
the ,food and ,drug ,administration     
,amendments ,act of #bjjg 7#db ,u4,s4,c4
 #bdg;d-#e;a2 relating to identification
 of clinically susceptible              
concentrations of antimicrobials7 is    
repealed4  7c7 ,report to ,congress ,not
 later than one year after the date of  
enactment of this ,act1 the ,secretary  
of ,health and ,human ,services shall   
submit to the ,committee on ,energy and 
,commerce of the ,house of              
,representatives and the ,committee on  
,health1 ,education1 ,labor1 and        
,pensions of the ,senate a report on the
 progress made in implementing section  
#eaa of the ,federal ,food1 ,drug1 and  
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;a71  
as amended by this section4  #d4 ,no    
effect on health care practice ,nothing 
in the ,antibiotic ,development to      
,advance ,patient ,treatment ,act of    

#bjac 7including the amendments made    
thereby7 shall be construed to restrict1
 in any manner1 the prescribing of      
antibiotics or other products by health 
care professionals1 or to limit the     
practice of health care4