,i  #aaeth ,,congress  #ast ,session    
,h4 ,r4 #gdi  ,,in ,,the ,,house ,,of   
,,representatives  ,january #cj1        
#bjag,mr4 ,schrader 7for himself1 ,mr4  
,bilirakis1 ,mr4 ,lipinski1 ,mr4        
,moulton1 ,mr4 ,bera1 ,ms4 ,sinema1 ,mr4
 ,cooper1 ,mr4 ,posey1 ,mr4 ,costa1 and 
,mr4 ,peters7 introduced the following  
bill2 which was referred to the         
,committee on ,energy and ,commerce  ,a 
,,bill  ,to increase competition in the 
pharmaceutical industry4  #a4 ,short    
title ,this ,act may be cited as the    
,lower ,drug ,costs through ,competition
 ,act4  #b4 ,findings ,congress finds   
the following3  7#a7 ,as part of the    
,food and ,drug ,administration's       
mission to protect the public health1   
the ,food and ,drug ,administration     
approves generic drugs that help        
establish competitive markets for       
treatments that improve the lives of    
millions of patients in the ,united     
,states4  7#b7 ,rising health care      
costs1 including prescription drug      

costs1 continue to be a major concern   
for patients in the ,united ,states4    
7#c7 ,eighty-eight percent of           
prescription drugs dispensed in the     
,united ,states1 or nearly #i out of    
every #aj prescriptions dispensed1 are  
generic drugs4  7#d7 ,studies suggest   
that generic drugs account for only #bh 
percent of total prescription drug      
spending and were responsible for       
#a1fhj1jjj1jjj1jjj in estimated savings 
over the period of #bjje to #bjad4  7#e7
 ,increasing generic competition can be 
an effective way to help keep           
prescription drug costs low for         
patients1 the health care system1 and   
,federal and ,state government4  7#f7   
,while the ,food and ,drug              
,administration has made progress toward
 a more consistent timeline for generic 
drug approvals since the enactment of   
the ,generic ,drug ,user ,fee           
,amendments of #bjab 7#ba ,u4,s4,c4     
#cgi;j-#da et seq471 a significant      
backlog of abbreviated new drug         

applications for generic drugs remains4 
7#g7 ,the sudden1 aggressive price hikes
 for a variety of recently acquired     
off-patent drugs that have been used    
widely for decades1 for which there is  
no generic drug competitor1 also affects
 access to affordable prescriptions for 
patients and the overall cost of health 
care in the ,united ,states4  7#h7      
,improving the review of abbreviated new
 drug applications and the approval of  
generic drugs would help to improve     
competition and lower prices for        
patients4  7#i7 ,establishing a clear   
timeframe for the ,food and ,drug       
,administration to expedite the review  
of certain applications for generic     
drugs would also help keep drug prices  
down and improve timely access for      
patients4  ,i ,removing regulatory      
barriers to competition  #aja4          
,improving generic access ,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 review1 
and act not later than #ahj calendar    
days after the date of the submission of
 an application1 on an application that 
has been submitted and accepted for     
review under this subsection1 or on a   
supplement to such an application1 that 
is for a drug that--  7i7 has been      
introduced into interstate commerce by  
not more than one manufacturer or       
sponsor1 as applicable1 in the last #c  
months and with respect to which        
tentative approval under paragraph 7#e7 
has been granted for not more than #b   
applications2 or  7ii7 has been included
 on the list under section #ejf;,e4     
7,b7 ,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  4  #ajb4 ,reporting 
on pending generic drug applications    
,not later than #ahj calendar days after
 the date of enactment of this ,act1 and

 every #ahj calendar days thereafter    
until ,october #a1 #bjbc1 the ,secretary
 of ,health and ,human ,services shall  
submit to the ,committee on ,health1    
,education1 ,labor1 and ,pensions of the
 ,senate1 the ,special ,committee on    
,aging of the ,senate1 and the          
,committee on ,energy and ,commerce of  
the ,house of ,representatives a report 
that provides--  7#a7 the number of     
applications that were filed under      
section #eje7;j7 of the ,federal ,food1 
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee7;j77 prior to ,october #a1 #bjag1 
that are pending at the time the report 
is submitted2  7#b7 the average and     
median total time such applications have
 been pending2  7#c7 the number of such 
applications that contain certifications
 under section                          
#eje7;j77#b77;,a77vii77,,iv7 of such    
,act2 and  7#d7 the number of such      
applications that are subject to        
priority review4  ,,ii ,incentivizing   
competition  #bja4 ,generic priority    

review voucher ,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;,f the following3  #ejf;,g4        
,generic priority review voucher  7a7   
,definitions ,in this section3 7#a7 ,the
 term priority review with respect to an
 application under section #eje7;j7     
means review and action by the          
,secretary on such application by the   
,secretary not later than #ahj calendar 
days after such application has been    
submitted and accepted for review4  7#b7
 ,the term priority review voucher means
 a voucher for priority review for an   
application under section #eje7;j74     
,such voucher shall be awarded upon the 
approval of the application described in
 #eje7;j77#aa77;,a71 unless such        
application contains a certification    
under section                           
#eje7;j77#b77;,a77vii77,,iv74  7b7      
,generic ,priority ,review ,vouchers1 in
 general ,beginning on ,october #a1     

#bjah1 the ,secretary shall award a     
priority review voucher to the sponsor  
of an application described in section  
#eje7;j77#aa77;,a7 upon--  7#a7 approval
 by the ,secretary of such application2 
7#b7 marketing of the drug subject to   
such application2 and  7#c7             
determination by the ,secretary that the
 drug has a sustained market presence4  
7c7 ,transferability  7#a7 ,in general  
,the recipient of a priority review     
voucher under subsection 7a7 may        
transfer 7including by sale7 the        
entitlement to such voucher4 ,there is  
no limit on the number of times a       
priority review voucher may be          
transferred before such voucher is used4
  7#b7 ,notification to the ,secretary  
,each person to whom a voucher is       
transferred shall notify the ,secretary 
of such change in ownership of such     
voucher not later than #cj calendar days
 after such transfer4  7d7 ,notification
 ,the sponsor shall notify the          
,secretary not later than #cj calendar  

days prior to the submission of a human 
drug application that is intended to be 
the subject of a priority review        
voucher1 except in the case of such an  
application that was pending as of      
,october #a1 #bjah1 in which case the   
sponsor of such pending application     
shall notify the ,secretary not later   
than #cj days after the date on which   
such voucher is awarded4  7e7 ,fees     
7#a7 ,in general ,the sponsor of an     
application that is the subject of a    
priority review voucher shall be subject
 to the fees required under subchapter  
,c of chapter ,,vii4  7#b7 ,priority    
review user fee  7,a7 ,in general ,the  
,secretary shall establish a user fee   
program under which a sponsor of a human
 drug application that is the subject of
 a priority review voucher shall pay to 
the ,secretary a fee determined under   
subparagraph 7,b74 ,such fee shall be in
 addition to any fee required to be     
submitted by the sponsor under          
subchapter ,c of chapter ,,vii4  7,b7   

,fee amount ,the amount of the priority 
review user fee shall be determined each
 fiscal year by the ,secretary1 based on
 twice the difference between--  7i7 the
 average cost incurred by the ,food and 
,drug ,administration in the review of a
 human drug application subject to      
priority review under this section in   
the previous fiscal year2 and  7ii7 the 
average cost incurred by the ,food and  
,drug ,administration in the review of a
 human drug application under section   
#eje7;j7 that is not subject to priority
 review under this section in the       
previous fiscal year4  7,c7 ,annual fee 
setting ,the ,secretary shall establish1
 before the beginning of each fiscal    
year beginning after ,september #cj1    
#bjah1 and in accordance with           
subparagraph 7,b71 the amount of the    
priority review user fee for that fiscal
 year4  7,d7 ,payment  7i7 ,in general  
,the priority review user fee required  
by this paragraph shall be due upon the 
notification by a sponsor of the intent 

of such sponsor to use the voucher1 as  
specified in subsection 7d74 ,all other 
user fees associated with the human drug
 application shall be due as required by
 the ,secretary or under applicable law4
  7ii7 ,complete application ,an        
application described in clause 7i7 for 
which the sponsor requests the use of a 
priority review voucher shall be        
considered incomplete if the fee        
required by this paragraph and all other
 applicable user fees are not paid in   
accordance with the ,secretary's        
procedures for paying such fees4  7iii7 
,no waivers1 exemptions1 reductions1 or 
refunds ,the ,secretary may not grant a 
waiver1 exemption1 reduction1 or refund 
of any fees due and payable under this  
paragraph4  7,e7 ,offsetting collections
 ,fees collected pursuant to this       
paragraph for any fiscal year-- 7i7     
shall be deposited and credited as      
offsetting collections to the account   
providing appropriations to the ,food   
and ,drug ,administration2 and  7ii7    

shall not be collected for any fiscal   
year except to the extent provided in   
advance in appropriations ,acts4  7f7   
,clarification ,nothing in this section 
affects any period of exclusivity under 
this ,act or the protection of any      
patent4  7g7 ,sunset ,the authority of  
the ,secretary to carry out the generic 
priority review voucher program under   
this section shall terminate on ,october
 #a1 #bjbc4  4  #bjb4 ,tropical disease 
product application ,section            
#ebd7;a77#d77;,a7 of the ,federal ,food1
 ,drug1 and ,cosmetic ,act 7#ba         
,u4,s4,c4 #cfjn7a77#d77;,a77 is         
amended--  7#a7 in clause 7i71 by       
striking and2  7#b7 in clause 7ii71 by  
adding and after the semicolon2 and     
7#c7 by adding at the end the following3
  7iii7 that contains reports of new    
clinical investigations 7other than     
bioavailability studies7 essential to   
the approval of the application and     
conducted or sponsored by the applicant2
  4  ,,iii ,study on ,,rems  #cja4      

,study on ,,rems  7a7 ,in general ,the  
,comptroller ,general shall conduct a   
review of the implementation and        
effectiveness of section #eje-a of the  
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee-a7 7referred to
 in this section as the ,,rems program71
 which section--  7#a7 authorizes the   
,secretary of ,health and ,human        
,services to require a risk evaluation  
and mitigation strategy 7referred to in 
this section as ,,rems72 and  7#b7      
codifies and expands regulations issued 
by the ,food and ,drug ,administration  
under which the ,food and ,drug         
,administration may impose restrictions 
on distribution necessary to ensure a   
drug is safely used4  7b7 ,contents of  
study ,in conducting the review under   
subsection 7a71 the ,comptroller        
,general shall examine each relevant    
element described in subsection 7c7 with
 respect to each of the following       
categories3  7#a7 ,new drug applications
 under subsection 7b7 of section #eje of

 the ,federal ,food1 ,drug1 and         
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b774
  7#b7 ,abbreviated new drug            
applications under subsection 7j7 of    
such section4  7#c7 ,applications for   
the license of a biological product     
under section #cea of the ,public       
,health ,service ,act 7#db ,u4,s4,c4    
#bfb74  7#d7 ,single1 shared system     
,,rems1 as described in section         
#eje-a7;i7 of the ,food1 ,drug1 and     
,cosmetic ,act 7#ba ,u4,s4,c4           
#cee-a7;i774  7#e7 ,controlled          
substances as defined in section #ajb of
 the ,controlled ,substances ,act 7#ba  
,u4,s4,c4 #hjb74  7#f7 ,r,i,s,k,m,a,ps  
or other risk management processes      
employed by the ,food and ,drug         
,administration4  7c7 ,elements under   
review ,in conducting the review under  
subsection 7a71 the ,comptroller        
,general shall examine each of the      
following elements with respect to each 
relevant category described in          
subsection 7b74  7#a7 ,for each type of 

application1 and by year1 the number of 
,,rems required1 submitted1 voluntarily 
submitted1 modified1 added1 approved1 or
 removed1 and whether those ,,rems      
included elements to assure safe use1   
such as restricted distribution4  7#b7  
,for each type of application1 the      
number of ,,rems in effect at the time  
of the review and the number of years   
that each such ,,rems has been in effect
 at such time4  7#c7 ,if and how the    
,,rems program has improved drug safety1
 as compared to the time before the     
,,rems program became effective1 and how
 the ,food and ,drug ,administration    
tracks such improvements4  7#d7 ,the    
burdens associated with ,,rems1         
including burdens on patients1 health   
care providers1 generic drug            
manufacturers1 brand drug manufacturers1
 pharmacies1 and wholesale distributors4
  7#e7 ,in the case of a ,,rems program 
for a drug containing a controlled      
substance1 the coordination between the 
,food and ,drug ,administration and the 

,drug ,enforcement ,administration4     
7#f7 ,the effect of additional risk     
mitigation strategies1 including        
non-,,rems restricted distribution      
systems1 imposed by companies outside of
 what is required under the ,,rems      
program4  7#g7 ,the standards and       
policies applied by the ,food and ,drug 
,administration to require1 modify1 add1
 or remove a ,,rems1 and how those      
standards and policies have changed     
since the ,,rems program became         
effective4  7#h7 ,the effect of ,,rems  
programs and additional risk mitigation 
strategies1 including non-,,rems        
restricted distribution systems1 on     
generic entry into the marketplace4     
7#i7 ,the effect of ,,rems programs and 
additional risk mitigation strategies1  
including non-,,rems restricted         
distribution systems1 on pharmaceutical 
prices4  7d7 ,report ,not later than    
,may #a1 #bjah1 the ,comptroller        
,general shall submit a report to the   
,committee on ,health1 ,education1      

,labor1 and ,pensions of the ,senate1   
the ,special ,committee on ,aging of the
 ,senate1 and the ,committee on ,energy 
and ,commerce of the ,house of          
,representatives1 containing the results
 of the review described in this        
section4