,i  #aafth ,,congress  #ast ,session    
,h4 ,r4 #ejci  ,,in ,,the ,,house ,,of  
,,representatives  ,november #ab1       
#bjai,mr4 ,lipinski introduced the      
following bill2 which was referred to   
the ,committee on ,energy and ,commerce1
 and in addition to the ,committee on   
,ways and ,means1 for a period to be    
subsequently determined by the ,speaker1
 in each case for consideration of such 
provisions as fall within the           
jurisdiction of the committee concerned 
,a ,,bill  ,to lower the prices of      
excessively costly life-sustaining      
prescription drugs under part ,d of the 
,medicare program by requiring the      
,secretary of ,health and ,human        
,services to negotiate their prices1 and
 for other purposes4  #a4 ,short title  
,this ,act may be cited as the          
,life-,sustaining ,prescription ,drug   
,price ,relief ,act of #bjai4  #b4      
,identification of excessively priced   
life-sustaining prescription drugs  7a7 
,in general ,the ,secretary1 not later  

than #a year after the date of enactment
 of this ,act1 shall establish a process
 to conduct a review of all             
life-sustaining prescription drugs1 not 
less frequently than once per calendar  
year1 under which the ,secretary        
determines under subsection 7b7 whether 
the price of each such drug is          
excessive4  7b7 ,excessive price        
determinations  7#a7 ,international     
reference price  7,a7 ,in general ,the  
,secretary shall determine that any     
life-sustaining prescription drug for   
which the domestic average manufacturing
 price exceeds #aaj percent of the      
average price charged for such drug in  
the #e reference countries to have an   
excessive price4 ,in assessing the      
extent to which the price is excessive1 
the ,secretary shall consider the       
factors described in paragraph 7#b74    
7,b7 ,reference ,countries ,in this     
,act1 the term reference countries means
 ,canada1 the ,united ,kingdom1         
,germany1 ,france1 and ,japan4  7,c7    

,requirement with respect to drugs for  
which certain reference country         
information is not available ,the       
,secretary shall make a determination   
under paragraph 7#a7 for every          
life-sustaining prescription drug for   
which pricing information is available  
for at least #c of the #e reference     
countries4  7#b7 ,determinations based  
on other factors ,with respect to any   
life-sustaining prescription drug that  
is not determined to have an excessive  
price by operation of paragraph 7#a7    
7including any drug for which there is  
insufficient data to make such a        
determination under such paragraph71 the
 ,secretary shall determine that such   
drug has an excessive price if the price
 of the drug is higher than reasonable  
taking into account the following       
factors3  7,a7 ,the size of the affected
 patient population4  7,b7 ,the risk    
adjusted value of ,federal ,government  
subsidies and investments related to the
 drug4  7,c7 ,the costs associated with 

development of the drug4  7,d7 ,whether 
the drug provided a significant         
improvement in health outcomes1 compared
 to other therapies available at the    
time of its approval4  7,e7 ,the        
cumulative global revenues generated by 
the drug4  7,f7 ,whether the domestic   
average manufacturer price of the drug  
increased during any annual quarter by a
 percentage that is more than the       
percentage increase in the consumer     
price index for all urban consumers for 
the respective annual quarter4  7,g7    
,other factors the ,secretary determines
 appropriate4  7c7 ,petition for        
determination  7#a7 ,in general ,any    
person may petition the ,secretary1 in  
accordance with section #eec7;e7 of     
title #e1 ,united ,states ,code1 to make
 an excessive drug price determination  
for an applicable drug under subsection 
7b77#b74 ,not later than #ij days after 
the date of receipt of such a petition1 
subject to paragraph 7#b71 the          
,secretary shall--  7,a7 make a         

determination under subsection 7b77#b7  
regarding such drug2 or  7,b7 7i7       
decline to make such a determination2   
and  7ii7 make public the reasons why   
the ,secretary has declined to make such
 a determination4  7#b7 ,exception ,the 
,secretary shall not make a             
determination under subsection 7b77#b7  
for a drug in response to a petition    
under this section more frequently than 
once per calendar year4  7#c7 ,public   
availability ,the ,secretary shall make 
any petitions submitted under this      
subsection1 together with any           
documentation related to the petitions  
and the ,secretary's determinations on  
such petitions and rationale for such   
determinations1 publicly available1     
including by posting such information on
 the database under section #e4  #c4    
,abolishing the prohibition on ,medicare
 negotiation of drug prices and         
requiring the ,secretary of ,health and 
,human ,services to negotiate prices of 
life-sustaining prescription drugs      

furnished under ,part ,d of the         
,medicare program ,section #ahfj;,d-#aa 
of the ,social ,security ,act 7#db      
,u4,s4,c4 #aciew-#aaa7 is amended by    
striking subsection 7i7 and inserting   
the following new subsection3  7i7      
,requirement ,to negotiate prices with  
respect to certain life-,sustaining     
prescription drugs  7#a7 ,in general    
,with respect to any life-sustaining    
prescription drug 7as defined in section
 #f7d7 of the ,life-,sustaining         
,prescription ,drug ,price ,relief ,act 
of #bjai71 if the ,secretary determines 
under section #b of such ,act that the  
price of the drug is excessive1 the     
,secretary shall1 notwithstanding any   
other provision of law1 negotiate with  
manufacturers1 prescription drug plan   
sponsors1 and ,,ma organizations the    
total payment 7including any discounts1 
rebates1 and other price concessions7   
that may be made by such sponsors and   
organizations during a negotiated price 
period 7as specified by the ,secretary7 

for such drugs with respect to such     
drugs furnished to individuals who are  
enrolled under a prescription drug plan 
or under an ,,ma-,,pd plan offered by   
such sponsor or organization1           
respectively4  7#b7 ,price limitation   
,in the case of a life-sustaining       
prescription drug that is negotiated by 
the ,secretary pursuant to paragraph    
7#a71 the total payment described in    
such paragraph may not exceed #aaj      
percent of the average price charged for
 such drug in the #e reference countries
 described in section #b7;b77#a77;,b7 of
 such ,act 7in this section referred to 
as the international reference price74  
7#c7 ,enforcement  7,a7 ,in general ,in 
the case of a manufacturer of a         
life-sustaining prescription drug for   
which the ,secretary has made a         
determination described in paragraph    
7#a7 that fails to enter into a         
negotiation and agree on a total payment
 with respect to such drugs as described
 in such paragraph within #i months of  

such determination--  7i7 if such drug  
has an international reference price1   
the ,secretary shall assess a civil     
monetary penalty equal to #b times the  
difference between the total revenue for
 such drug from all sales in the ,united
 ,states made beginning after the date  
that is #i months after such            
determination and the total revenue for 
such drug from all such sales made after
 such date that would have been received
 if the manufacturer charged the        
international reference price for such  
drug2 and  7ii7 if such drug has an     
international reference price1 the      
,secretary shall assess a civil monetary
 penalty equal to #ej percent of the    
revenue from all ,united ,states sales  
of the drug in the first #ij days after 
the date that is #i months after such   
determination1 #ge percent of the value 
of all revenue from such sales during   
the following #ij days1 and #ie percent 
of all revenue from such sales in       
subsequent days until such time as an   

agreement is reached or an international
 reference price is available4  7,b7    
,deposit into trust fund ,civil monetary
 penalties collected pursuant to        
subparagraph 7,a7 shall be deposited    
into the ,federal ,hospital ,insurance  
,trust ,fund4  4  #d4 ,public excessive 
drug price database  7a7 ,excessive drug
 price database  7#a7 ,in general ,the  
,secretary shall establish and maintain 
a comprehensive1 up-to-date database of 
life-sustaining prescription drugs and  
the excessive price determinations for  
such drugs under section #b4  7#b7      
,contents ,the database shall include1  
at a minimum1 for each life-sustaining  
prescription drug1 for the applicable   
calendar year--  7,a7 the name of the   
drug2  7,b7 the manufacturer2  7,c7     
whether the drug was determined under   
section #b7;b7 to have an excessive     
price2 and  7,d7 the number of petitions
 the ,secretary received under section  
#b7;c7 to make an excessive price       
determination for the drug1 together    

with the information described in       
section #b7;c77#c74  7#c7 ,certain      
determinations ,with respect to a       
determination made under section        
#b7;b77#a71 the ,secretary shall publish
 on the database such determination in  
accordance with paragraph 7#a7 within   
#cj days of receiving domestic and      
international pricing information from  
manufacturers under section #f4  7b7    
,annual reports to ,congress ,not later 
than #fj days after the first excessive 
price review under section #b is        
complete1 and annually thereafter1 the  
,secretary shall submit to ,congress a  
report describing the excessive drug    
price review for the preceding year4    
,the report shall contain summary data  
regarding--  7#a7 the total number of   
drugs that were reviewed2  7#b7 the     
total number of drugs determined to be  
excessively priced under each of        
paragraphs 7#a7 and 7#b7 of section     
#b7;b71 and the name and manufacturer of
 each such drug2  7#c7 the total number 

of drugs determined to be excessively   
priced1 listed by manufacturer2  7#d7   
the extent to which the prices of the   
drugs identified under section #b were  
higher than reasonable1 on average2     
7#e7 the total number of petitions the  
,secretary received under section #b7;c7
 to make excessive price determinations 
for drugs2  7#f7 a list of any          
manufacturers who failed to report      
information as required under section   
#f2 and  7#g7 other appropriate         
information1 as the ,secretary          
determines or as ,congress requests4    
7c7 ,public availability ,the ,secretary
 shall make the information in the      
database described in subsection 7a7 and
 the report in subsection 7b7 publicly  
available1 including on the internet    
website of the ,food and ,drug          
,administration1 in a manner that is    
easy to find and understand4  #e4 ,drug 
manufacturer reporting  7a7 ,in general 
,each manufacturer shall submit to the  
,secretary1 in such format as the       

,secretary may require1 an annual report
 that includes the following information
 for each life-sustaining prescription  
drug of the manufacturer1 with respect  
to the previous calendar year3  7#a7    
,the average manufacturer price of the  
drug in the ,united ,states and in the  
reference countries1 for the entire     
year1 and broken down for each quarter  
of the year4  7#b7 ,the wholesale       
acquisition cost of the drug in the     
,united ,states and in the reference    
countries1 for the entire year1 and     
broken down for each quarter of the     
year4  7#c7 ,cumulative global revenues 
generated by the drug4  7#d7 ,annual net
 sales revenue generated by the drug in 
the ,united ,states and in the reference
 countries1 for the entire year1 and    
broken down for each quarter of the     
year4  7#e7 ,total expenditures on      
domestic and foreign drug research and  
development related to the drug1        
itemized by--  7,a7 basic and           
preclinical research2  7,b7 clinical    

research1 reported separately for each  
clinical trial2  7,c7 development of    
alternative dosage forms and strengths  
for the drug molecule or combinations1  
including the molecule2  7,d7 other drug
 development activities1 such as        
nonclinical laboratory studies and      
record and report maintenance2  7,e7    
pursuing new or expanded indications for
 such drug through supplemental         
applications under section #eje of the  
,federal ,food1 ,drug1 and ,cosmetic    
,act2 and  7,f7 carrying out postmarket 
requirements related to such drug1      
including under section #eje7o77#c7 of  
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act4  7#f7 ,total expenditures on     
domestic and foreign marketing and      
advertising related to the drug4  7#g7  
,investments in human clinical trials   
related to the drug1 by each trial and  
each year1 including grants1 research   
contracts1 tax credits or deductions1   
and reimbursements from public or       
private health plans or insurance1 and  

any other public sector subsidies or    
incentives1 such as the fair market     
value or priority review vouchers or    
other considerations4  7#h7 ,the        
estimated size of the affected patient  
population4  7#i7 ,additional           
information the manufacturer chooses to 
provide related to drug pricing         
decisions1 such as information related  
to the methodology used to set the price
 of the drug4  7#aj7 ,additional        
information as the ,secretary determines
 necessary to carry out this ,act1      
including information for previous      
years4  7b7 ,report due date ,applicable
 manufacturers shall submit the reports 
described in subsection 7a7 not later   
than ,january #ae of the year following 
the date of enactment of this ,act1 and 
of each year thereafter4  7c7 ,penalty  
for noncompliance  7#a7 ,in general ,any
 manufacturer that fails to submit      
information for a drug as required by   
this section on a timely basis or that  
knowingly provides false information    

shall be liable for a civil monetary    
penalty1 as determined by the ,secretary
 under paragraph 7#b71 in addition to   
any other penalty under other applicable
 provisions of law4  7#b7 ,amount of    
penalty ,the amount of a civil penalty  
under paragraph 7#a7 shall be equal to  
the product of-- 7,a7 an amount1 as     
determined appropriate by the           
,secretary1 which is--  7i7 not less    
than #j4e percent of the gross revenues 
from sales for the previous calendar    
year of the drug for which the          
information was not submitted2 and  7ii7
 not greater than #a percent of the     
gross revenues from sales for the       
previous calendar year of such drug2 and
  7,b7 the number of days in the period 
between-- 7i7 the report due date under 
subsection 7b72 and  7ii7 the date on   
which the ,secretary receives the       
information required to be reported by  
the manufacturer under this section4    
7#c7 ,use of civil penalty ,the         
,secretary shall collect the civil      

penalties under this subsection and     
shall use such funds to support         
competitive research grant programs of  
the ,national ,institutes of ,health4   
#f4 ,definitions ,for the purposes of   
this ,act3 7#a7 ,average manufacturer   
price  7,a7 ,in general ,the term       
average manufacturer price1 with respect
 to a drug1 subject to subparagraph     
7,b71 has the meaning given such term in
 section #aibg7k77#a7 of the ,social    
,security ,act 7#db ,u4,s4,c4           
#acifr-#h7k77#a772 or with respect to a 
drug for which there is no average      
manufacturer price as so defined1 such  
term shall mean the wholesale           
acquisition cost 7as defined in section 
#ahdg;,a7c77#f77;,b7 of the ,social     
,security ,act 7#db ,u4,s4,c4           
#aciew-#c;a7c77#f77;,b77 of the drug4   
7,b7 ,application to reference countries
 ,with respect to reference countries1  
the term average manufacturer price1 as 
defined in subparagraph 7,a71 shall be  
determined based on the price of the    

drug in the applicable reference        
country4  7#b7 ,biosimilar biological   
product ,the term biosimilar biological 
product means a biological product      
licensed pursuant to an application     
under section #cea7k7 of the ,public    
,health ,service ,act 7#db ,u4,s4,c4    
#bfb7k774  7#c7 ,generic drug ,the term 
generic drug means a drug approved      
pursuant to an application under section
 7b77#b7 or 7j7 of the ,federal ,food1  
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee74  7#d7 ,life-sustaining          
prescription drug ,the term             
life-sustaining prescription drug means 
a drug that is-- 7,a7 approved under    
subsection 7c7 or 7j7 of section #eje of
 the ,federal ,food1 ,drug1 and         
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or a
 biological product licensed under      
subsection 7a7 or 7k7 of section #cea of
 the ,public ,health ,service ,act 7#db 
,u4,s4,c4 #bfb72  7,b7 subject to       
section #ejc7;b77#a7 of the ,federal    
,food1 ,drug1 and ,cosmetic ,act 7#ba   

,u4,s4,c4 #cec7;b77#a772 and  7,c7      
life-sustaining 7as such term is defined
 in regulation pursuant to section      
#ejf;,c of the ,federal ,food1 ,drug1   
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#cef;c774  7#e7 ,manufacturer ,the term 
manufacturer means the holder of an     
application approved under section #eje 
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or  
of a license issued under section #cea  
of the ,public ,health ,service ,act    
7#db ,u4,s4,c4 #bfb74  7#f7 ,secretary  
,the term ,secretary means the          
,secretary of ,health and ,human        
,services4