,,ii  #aaeth ,,congress  #ast ,session  
,s4 #aaae  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,may #aa1      
#bjag,ms4 ,collins 7for herself1 ,mrs4  
,mc,caskill1 ,mr4 ,cotton1 and ,mr4     
,franken7 introduced the following bill2
 which was read twice and referred to   
the ,committee on ,health1 ,education1  
,labor1 and ,pensions  ,a ,,bill  ,to   
improve access to prescription drugs4   
#a4 ,short title ,this ,act may be cited
 as the ,making ,pharmaceutical ,markets
 ,more ,competitive ,act4  ,i ,removing 
regulatory barriers to competition      
#aja4 ,improving access to generic drugs
 ,section #eje7;j7 of the ,federal      
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cee7;j77 is amended by adding
 at the end the following3  7#aa7 7,a7  
,the ,secretary shall prioritize the    
review of1 and act within #bdj calendar 
days of the date of the submission of1  
an original abbreviated new drug        
application submitted for review under  
this subsection1 or on a supplement to  

such an application1 that is for a      
drug--  7i7 for which there are not more
 than #c approved drugs listed under    
paragraph 7#g71 except that the review  
of an application submitted more than   
#cj months in advance of the last       
applicable expiration date for a patent 
for which a certification under         
paragraph 7#b77;,a77vii77,,iii7 has been
 submitted1 or of the expiration date   
for an applicable period of exclusivity 
under this ,act1 will not be expedited2 
or  7ii7 that has been included on the  
list under section #ejf;,e4  7,b7 ,the  
,secretary shall require the applicant1 
not later than #fj days prior to the    
submission of an application described  
in subparagraph 7,a71 to provide        
complete1 accurate information regarding
 facilities involved in manufacturing   
processes and testing1 including        
facilities in corresponding ,type ,,ii  
active pharmaceutical ingredients drug  
master files submitted with an          
application and sites or organizations  

involved in bioequivalence and clinical 
studies used to support the application1
 in order to make a determination       
regarding whether an inspection of an   
establishment is necessary4  7,c7 ,the  
,secretary may expedite an inspection or
 reinspection under section #gjd of an  
establishment that proposes to          
manufacture a drug described in         
subparagraph 7,a74  7,d7 ,nothing in    
this paragraph shall prevent the        
,secretary from prioritizing the review 
of other applications as the ,secretary 
determines appropriate4  7#ab7 ,the     
,secretary shall provide review status  
updates to applicants regarding         
applications under this subsection1 as  
appropriate1 including when the         
application is awaiting final regulatory
 action by the office charged with      
review4  7#ac7 ,the ,secretary shall    
publish on the ,internet website of the 
,food and ,drug ,administration a list  
of all drugs approved under subsection  
7b7 for which all patents and periods of

 exclusivity under this ,act have       
expired4 ,such list shall be updated at 
least once every #ahj days4  4  #ajb4   
,reporting on pending generic drug      
applications1 priority review           
applications1 and inspections  7a7 ,in  
general ,not later than #ahj calendar   
days after the date of enactment of this
 ,act1 and quarterly thereafter until   
,october #a1 #bjbb1 the ,secretary of   
,health and ,human ,services 7referred  
to in this section as the ,secretary7   
shall post on the ,internet website of  
the ,food and ,drug ,administration a   
report that provides--  7#a7 the number 
of applications filed under section     
#eje7;j7 of the ,federal ,food1 ,drug1  
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#cee7;j77 awaiting action by the        
applicant1 including such applications  
that were filed prior to ,october #a1   
#bjad2  7#b7 the number of applications 
filed under section #eje7;j7 of the     
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7;j77 awaiting  

action by the ,secretary1 including such
 applications that were filed prior to  
,october #a1 #bjad2  7#c7 the number of 
applications filed under section        
#eje7;j7 of the ,federal ,food1 ,drug1  
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#cee7;j77 and prior approval supplements
 withdrawn in each month covered by the 
report2  7#d7 the mean and median       
approval and tentative approval times   
for applications covered by the report2 
7#e7 the number of applications         
described in paragraphs 7#a71 7#b71 and 
7#c7 that are subject to priority       
review2 and  7#f7 the number of such    
applications on which the ,secretary has
 taken action pursuant to section       
#ejf;,h7b7 of the ,federal ,food1 ,drug1
 and ,cosmetic ,act1 as added by section
 #aja4  7b7 ,annual report on priority  
review applications  7#a7 ,in general   
,the ,secretary shall submit to the     
,committee on ,health1 ,education1      
,labor1 and ,pensions and the ,special  
,committee on ,aging of the ,senate and 

the ,committee on ,energy and ,commerce 
of the ,house of ,representatives an    
annual report1 not later than ,march #ca
 of each year1 on the following3  7,a7  
,the number of applications filed under 
section #eje7;j7 of the ,federal ,food1 
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee7;j77 that are subject to priority 
review during the most recent calendar  
year and are awaiting action by the     
applicant4  7,b7 ,the number of         
applications filed under section        
#eje7;j7 of the ,federal ,food1 ,drug1  
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#cee7;j77 that are subject to priority  
review during the most recent calendar  
year and are awaiting action by the     
,secretary4  7,c7 ,the number of        
applications filed under section        
#eje7;j7 of the ,federal ,food1 ,drug1  
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#cee7;j77 that are subject to priority  
review during the most recent calendar  
year and have been approved by the      
,secretary4  7,d7 ,for each of          

subparagraphs 7,a7 through 7,c71 the    
number of such applications-- 7i7 for   
which there are not more than #c        
approved drugs listed under section     
#eje7;j77#g7 of the ,federal ,food1     
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee7;j77#g772 and  7ii7 the number of 
such applications that are for a drug on
 the drug shortage list under section   
#ejf;,e of the ,federal ,food1 ,drug1   
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#cef;e74  7c7 ,annual report on         
inspections ,not later than ,march #a of
 each year1 the ,secretary shall post on
 the ,internet website of the ,food and 
,drug ,administration--  7#a7 the       
average and median amount of time1      
following a request by staff of the     
,food and ,drug ,administration         
reviewing an application or report      
submitted under an applicable section   
described in subparagraph 7,a71 7,b71 or
 7,c71 to schedule and complete         
inspections of facilities necessary     
for--  7,a7 approval of a drug under    

section #eje of the ,federal ,food1     
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee72  7,b7 approval of a device under
 section #eae of such ,act 7#ba         
,u4,s4,c4 #cfj;e72 and  7,c7 clearance  
of a device under section #eaj7k7 of    
such ,act 7#ba ,u4,s4,c4 #cfj7k772 and  
7#b7 the average and median amount of   
time to schedule and complete for-cause 
inspections of facilities of drugs and  
devices4  ,,ii ,incentivizing           
competition  #bja4 ,expediting generic  
competition ,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;,g the     
following3  #ejf;,h4 ,expediting generic
 drug development  7a7 ,in general ,the 
,secretary shall1 at the request of an  
applicant1 expedite the development and 
review of an application under          
subsection 7j7 of section #eje for a    
drug--  7#a7 for which there are not    
more than #c approved drug products     
listed under section #eje7;j77#g72 or   

7#b7 that is included on the list under 
section #ejf;,e4  7b7 ,request from     
sponsors ,a request to expedite the     
development and review of an application
 under subsection 7a7 shall be submitted
 by the applicant prior to the          
submission of such application4  7c7    
,other applications ,nothing in this    
section shall prevent the ,secretary    
from expediting the development and     
review of other applications as the     
,secretary determines appropriate4  7d7 
,additional communication ,the          
,secretary shall take such actions as   
are appropriate to expedite the         
development and review of the           
application for approval of a drug      
described in subsection 7a71 including1 
as appropriate--  7#a7 holding meetings 
with the sponsor and the review team    
throughout the development of the drug  
prior to submission of the application2 
7#b7 providing timely advice to1 and    
interactive communication with1 the     
sponsor regarding the development of the

 application to ensure that the         
collection of nonclinical and clinical  
data necessary for approval is as       
efficient as practicable2  7#c7 in the  
case of a complex product1 assigning a  
cross-disciplinary project lead for the 
review team to facilitate an efficient  
review of the development program and   
application1 including manufacturing    
inspections2 and  7#d7 in the case of a 
complex product1 including drug-device  
combinations1 involving senior managers 
and experienced review staff1 as        
appropriate1 in a collaborative1        
cross-disciplinary review4  7e7         
,reporting requirement ,a sponsor of a  
drug expedited under this section shall 
report to the ,secretary1 one year      
following approval of an application    
under section #eje7;j71 on whether the  
approved drug has been marketed in      
interstate commerce since approval4  4  
#bjb4 ,list of generic drugs with       
limited competition ,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;,h1 as added by section #bja1 the  
following3  #ejf;,i4 ,drug listing  7a7 
,removal1 withdrawal1 or transfer ,the  
holder of an application approved under 
subsection 7b7 or 7j7 of section #eje   
shall notify the ,secretary within #ahj 
days of removing the drug that is the   
subject of such application from        
interstate commerce1 withdrawing such   
approved application1 or transferring   
such approved application1 and a reason 
for such removal1 withdrawal1 or        
transfer4 ,if compliance with this      
subsection within such #ahj-;day period 
is not practicable1 then the holder     
shall comply as soon as practicable4    
,the ,secretary shall cross-reference   
information listed pursuant to section  
#ejf;,c where applicable to avoid       
duplicative reporting4 ,notification to 
the ,secretary by a manufacturer in     
accordance with section #ejf;,c7a7 shall
 be deemed to be compliance with this   

section4  7b7 ,drugs with limited       
competition  7#a7 ,information ,the     
,secretary shall-- 7,a7 maintain        
information with respect to applications
 approved under section #eje7;j72 and   
7,b7 publish on the ,internet website of
 the ,food and ,drug ,administration    
such information under subparagraph 7,a7
 with respect to drugs for which there  
are three or fewer application holders2 
and  7,c7 update the information        
published pursuant to subparagraph 7,b7 
every #ahj days4  7#b7 ,contents ,the   
public information maintained and       
published under paragraph 7#a77;,b7     
shall include--  7,a7 the name of the   
drug1 name of the holder of the approved
 application1 and the marketing status  
for each drug2 and  7,b7 an indication  
of whether the ,secretary considers the 
drug to be for the treatment or         
prevention of a serious disease or      
medical condition1 for which there is no
 alternative drug that is judged by     
medical professionals to be an adequate 

substitute available in adequate supply4
  7c7 ,public health exception ,the     
,secretary may choose not to make       
information collected under this section
 publicly available if the ,secretary   
determines that disclosure of such      
information would adversely affect the  
public health4  7d7 ,notification ,when 
the ,secretary first publishes the      
information under subsection 7b71 the   
,secretary shall notify relevant        
,federal agencies1 including the        
,centers for ,medicare  ,medicaid       
,services and the ,federal ,trade       
,commission1 that the information has   
been published and will be updated      
regularly4  4  #bjc4 ,suitability       
petitions  7a7 ,in general ,it is the   
sense of the ,senate that the ,food and 
,drug ,administration shall meet the    
requirement under section               
#eje7;j77#b77;,c7 of the ,federal ,food1
 ,drug1 and ,cosmetic ,act 7#ba         
,u4,s4,c4 #cee7;j77#e77;,c77 and section
 #cad4ic7;e7 of title #ba1 ,code of     

,federal ,regulations1 of responding to 
suitability petitions within #ij days of
 submission4  7b7 ,report ,the          
,secretary of ,health and ,human        
,services shall include in the annual   
reports under section #ajb7;b7--  7#a7  
the number of pending petitions under   
section #eje7;j77#b77;,c7 of the        
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,c772 
and  7#b7 the number of such petitions  
pending a substantive response for more 
than #ahj days from the date of receipt4
  #bjd4 ,inspections ,section #eje7;j7  
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j771
 as amended by section #aja1 is further 
amended by adding at the end the        
following3  7#ad7 ,if the ,secretary    
issues feedback pursuant to section     
#gjd7;b77#b7 with respect to information
 submitted in response to a report under
 section #gjd7;b77#a71 and a report that
 was issued under section #gjd7;b77#a7  
is the only obstacle to approval of an  

application under this subsection or the
 ,secretary determines that the public  
health benefit of approving an          
application under this subsection       
outweighs any risk to public health1 the
 ,secretary shall1 within #de days of   
notification by the applicant that      
necessary changes have been made to the 
establishment to address any findings or
 deficiencies identified previously by  
the ,secretary--  7,a7 re-inspect the   
establishment with respect to which the 
report was issued2 or  7,b7 make a      
determination regarding the response to 
such report and review of such          
application4  4