,i  #aaeth ,,congress  #b;d ,session    
,h4 ,r4 #egci  ,,in ,,the ,,house ,,of  
,,representatives  ,may #i1 #bjah,ms4   
,de,lauro 7for herself1 ,mr4 ,doggett1  
and ,ms4 ,moore7 introduced the         
following bill2 which was referred to   
the ,committee on ,energy and ,commerce1
 and in addition to the ,committees on  
,ways and ,means1 and the ,judiciary1   
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     
establish within the ,department of     
,health and ,human ,services the        
,prescription ,drug and ,medical ,device
 ,price ,review ,board to regulate the  
prices of certain prescription drugs and
 medical devices1 and for other         
purposes4  #a4 ,short title ,this ,act  
may be cited as the ,prescription ,drug 
and ,medical ,device ,price ,review     
,board ,act of #bjah4  #b4              
,establishment ,there is established in 

the ,department of ,health and ,human   
,services a board to be known as the    
,prescription ,drug and ,medical ,device
 ,price ,review ,board 7in this ,act    
referred to as the ,board74  #c4        
,membership2 staff  7a7 ,members ,the   
,board shall be composed of #e members  
as follows3 7#a7 ,the ,assistant        
,secretary for ,planning and ,evaluation
 of the ,department of ,health and      
,human ,services 7or the ,assistant     
,secretary's designee74  7#b7 ,the      
,administrator of the ,centers for      
,medicare  ,medicaid ,services 7or the  
,administrator's designee74  7#c7 ,the  
,assistant ,director for the ,health    
,services ,division of the ,federal     
,bureau of ,prisons 7or the ,assistant  
,director's designee74  7#d7 ,the       
,secretary of ,defense 7or the          
,secretary's designee74  7#e7 ,the      
,secretary of ,veterans ,affairs 7or the
 ,secretary's designee74  7#f7 ,the     
,commissioner of ,food and ,drugs 7or   
the ,commissioner's designee74  7b7     

,chairperson ,the ,board shall designate
 #a member of the ,board to serve as the
 chairperson4  7c7 ,director and staff  
7#a7 ,director ,the ,board shall have a 
director who shall be appointed by the  
chairperson of the ,board1 subject to   
rules prescribed by the ,board4  7#b7   
,staff ,the director may appoint and fix
 the pay of such additional personnel as
 the chairperson considers appropriate1 
subject to rules prescribed by the      
,board4  7#c7 ,applicability of certain 
civil service laws ,the director and    
staff of the ,board shall be appointed  
subject to the provisions of title #e1  
,united ,states ,code1 governing        
appointments in the competitive service1
 and shall be paid in accordance with   
the requirements of chapter #ea and     
subchapter ,,iii of chapter #ec of such 
title relating to classification and    
,general ,schedule pay rates2 except    
that an individual so appointed may not 
receive pay in excess of the maximum    
annual rate of basic pay payable for    

grade ,,gs-#ae of the ,general          
,schedule4  7d7 ,assistance for the     
board ,subject to section #g7;g71 in    
carrying out this ,act1 the ,board--    
7#a7 may seek assistance from outside   
experts in the fields of consumer       
advocacy1 medicine1 pharmacology1       
pharmacy1 and prescription drug         
reimbursement2 and  7#b7 shall establish
 and maintain an advisory group and a   
stakeholder group for purposes of       
seeking such assistance4  7e7 ,initial  
meeting ,the ,board shall hold its      
initial meeting not later than #ij days 
after the date of the enactment of this 
,act4  #d4 ,reporting requirements  7a7 
,reporting by manufacturers ,the ,board 
shall require each manufacturer of a    
prescription drug or medical device that
 is sold in the ,united ,states to      
submit to the ,board on a periodic      
basis1 at a level of specificity        
determined by the ,board to be necessary
 to make a determination under section  
#e1 the following information with      

respect to the reporting period3  7#a7  
,each type of prescription drug and     
medical device that is sold by the      
manufacturer or an affiliate of the     
manufacturer--  7,a7 in the ,united     
,states2 or  7,b7 in a country that is a
 member of the ,organization for        
,economic ,co-operation and             
,development4  7#b7 ,the price charged  
by the manufacturer and the affiliate   
for the prescription drug or medical    
device in the ,united ,states and in any
 such country1 as applicable4  7#c7 ,the
 costs of the manufacturer and the      
affiliate to produce and market the     
prescription drug or medical device for 
sale in the ,united ,states and in any  
such country1 as applicable4  7b7       
,reporting by ,,cbo ,the ,director of   
the ,congressional ,budget ,office shall
 submit an annual report to the ,board  
on trends in the prices charged for     
prescription drugs and medical devices4 
#e4 ,prohibition against excessive price
  7a7 ,prohibition ,beginning on the    

effective date of the regulation        
required by subsection 7b71 the         
manufacturer of a prescription drug or  
medical device shall not charge an      
excessive price1 as determined pursuant 
to such regulation1 for such drug or    
device4  7b7 ,formula ,the ,board shall 
by regulation prescribe a formula for   
determining whether the average         
manufacturer price of such drug or      
device over an annual quarter is an     
excessive price4  7c7 ,determination of 
excessive price ,if the ,board          
determines1 on its own initiative or in 
response to a petition submitted under  
subsection 7d71 that the manufacturer of
 a prescription drug or medical device  
charges an excessive price for such drug
 or device in violation of subsection   
7a7--  7#a7 the ,board shall give the   
manufacturer-- 7,a7 notice of such      
violation2 and  7,b7 subject to         
subsection 7d71 a period to correct such
 violation2 and  7#b7 if the            
manufacturer fails to correct the       

violation by the end of such period1 the
 manufacturer shall be subject to       
section #f of this ,act1 section        
#aibg7;c77#b77;,e7 of the ,social       
,security ,act1 as added by subsection  
7c7 of such section #f1 and section     
#daib of the ,internal ,revenue ,code of
 #aihf1 as added by subsection 7d7 of   
such section #f4  7d7 ,petitions ,any   
person may petition the ,board to make a
 determination under subsection 7c7     
regarding the pricing of a prescription 
drug or medical device4 ,not later than 
#ij days after the date of receipt of   
such a petition1 the ,board shall--     
7#a7 make a determination under         
subsection 7c7 regarding such pricing2  
or  7#b7 decline to make such a         
determination4  7e7 ,continuing         
violation ,the ,board shall not be      
required to give a manufacturer an      
opportunity to correct a violation1 as  
described in subsection 7c77#a77;,b71   
before the manufacturer becomes subject 
to the provisions described in          

subsection 7c77#b7 for such violation1  
if--  7#a7 the ,board has already       
provided such an opportunity to correct 
to the manufacturer2 and  7#b7 the      
,board finds that the violation of      
subsection 7a7 is a continuation of an  
earlier violation with respect to which 
such an opportunity was provided4  7f7  
,considerations ,the formula required by
 subsection 7a7 shall at a minimum take 
into consideration-- 7#a7 the average   
manufacturer price of the prescription  
drug or medical device over the         
respective annual quarter or quarters2  
7#b7 the average manufacturer price of  
other prescription drugs or medical     
devices in the same therapeutic class   
over the same quarter or quarters2  7#c7
 the average price at which the         
prescription drug or medical device and 
other prescription drugs and medical    
devices in the same therapeutic class   
have been sold by manufacturers in      
countries other than the ,united        
,states2  7#d7 the costs associated with

 producing and marketing the            
prescription drug or medical device1 the
 value of the drug or device to patients
 where sufficient data is available to  
determine such value1 the total ,federal
 investment in the development of the   
drug or device1 the size of the patient 
population receiving the drug or device1
 and other factors determinative as to  
the true cost of production2 and  7#e7  
whether the price of the prescription   
drug or medical device increased during 
any annual quarter by a percentage that 
is more than #b percent greater than the
 ,,cpi increase percentage 7as defined  
in section #bae7;i7 of the ,social      
,security ,act 7#db ,u4,s4,c4 #dae77 for
 the respective annual quarter4  #f4    
,enforcement provisions  7a7 ,reduced   
patent term ,if the ,board finds that   
the manufacturer of a prescription drug 
or medical device1 who is also an owner 
of a patent for such drug or device1    
charged an excessive price for such drug
 or device in violation of section      

#e7;a71 the ,board may--  7#a7 reduce   
the term1 by not more than #e years1 of 
any patent issued under title #ce1      
,united ,states ,code1 relating to such 
drug or device2 or  7#b7 if the term of 
each patent for such drug or device has 
expired1 reduce the term1 by not more   
than #e years1 of another patent owned  
by the patent owner relating to a       
prescription drug or medical device4    
7b7 ,civil penalties ,if the ,board     
determines under section #e7;c7 that a  
manufacturer of a prescription drug or  
medical device charged an excessive     
price for a prescription drug or medical
 device in violation of section #e7;a71 
the ,board may impose a civil penalty on
 the manufacturer of not more than #aj  
percent of the manufacturer's gross     
sales of the drug or device during the  
period beginning on the date on which an
 excessive price is first charged and   
ending on the date on which the         
manufacturer ceases to charge an        
excessive price4  7c7 ,enforcement      

through increased ,medicaid rebates     
7#a7 ,in general ,section #aibg7;c77#b7 
of the ,social ,security ,act 7#db      
,u4,s4,c4 #acifr-#h7;c77#b77 is         
amended-- 7,a7 in subparagraph 7,a71 by 
inserting 1 subject to subparagraph     
7,e71 after increased by2 and  7,b7 by  
adding at the end the following new     
subparagraph3  7,e7 ,discouraging       
excessive prices  7i7 ,in general ,in   
the case of a manufacturer of a single  
source drug or an innovator multiple    
source drug with a rebate agreement     
under this section1 if the ,prescription
 ,drug and ,medical ,device ,price      
,review ,board established under section
 #b of the ,prescription ,drug and      
,medical ,device ,price ,review ,board  
,act of #bjah determines under section  
#e7;a7 of such ,act that such           
manufacturer charged1 with respect to a 
#cj-;day period1 an excessive price for 
such drug1 and the ,board determines    
under clause 7ii7 to apply an increased 
amount described in such clause with    

respect to such manufacturer and drug1  
the amount of the rebate determined     
under subparagraph 7,a7 for such        
manufacturer and drug shall be1 subject 
to subparagraph 7,d71 increased by such 
amount for the #d rebate periods        
following such #cj-;day period4  7ii7   
,increased amount determination ,for    
purposes of clause 7i71 if the ,board   
described in such clause makes such a   
determination under such section #e7;a71
 with respect to a manufacturer and drug
 described in such clause1 the ,board   
may determine an increased amount to    
apply with respect to such manufacturer 
and drug and rebate period described in 
such clause4 ,such increased amount may 
not exceed the rebate amount that would 
otherwise be applied to such            
manufacturer and drug under this section
 for such rebate period1 without regard 
to this subparagraph4  4  7#b7          
,effective date ,this subsection and the
 amendments made by this subsection     
shall apply with respect to rebate      

agreements entered into after the date  
that is #fj days after the date of the  
enactment of this ,act4  7d7 ,tax on    
excess prescription drug and medical    
device profits  7#a7 ,determination of  
amount ,if the ,board determines under  
section #e7;a7 that a manufacturer1     
producer1 or importer of a prescription 
drug or medical device charged an       
excessive price for such prescription   
drug or medical device during a taxable 
year1 the ,board may determine under    
this paragraph a reasonable price for   
such drug or device for such taxable    
year4  7#b7 ,imposition of tax  7,a7 ,in
 general ,the ,internal ,revenue ,code  
of #aihf is amended by inserting after  
section #daia the following new section3
  #daib4 ,excessive prescription drug   
and medical device price  7a7 ,in       
general ,there is hereby imposed on the 
sale of any prescription drug or medical
 device by the manufacturer1 producer1  
or importer a tax equal to the          
difference between the price at which   

such drug or device is so sold and the  
reasonable price determined by the      
,prescription ,drug and ,medical ,device
 ,price ,review ,board under section    
#f7;d77#a7 of the ,prescription ,drug   
and ,medical ,device ,price ,review     
,board ,act of #bjah for such drug or   
device for the taxable year for sales   
after the determination4  7b7           
,prescription ,drug or ,medical ,device 
,for purposes of this section1 the term 
prescription drug or medical device     
means any prescription drug 7as defined 
in section #ijjh of the ,patient        
,protection and ,affordable ,care ,act7 
or device 7as defined in section        
#bja7;h7 of the ,federal ,food1 ,drug1  
and ,cosmetic ,act7 intended for humans4
  4  7,b7 ,clerical amendment ,the table
 of parts for chapter #cb of such ,code 
is amended-- 7i7 in the item relating to
 subchapter ,e1 by striking ,medical and
 inserting ,drugs and medical1 and  7ii7
 by inserting after the item relating to
 section #daia the following new item3  

,sec4 #daib4 ,excessive prescription    
drug and medical device price4  4  7#c7 
,effective date ,this subsection and the
 amendments made by this subsection     
shall apply with respect to sales after 
,december #ca1 #bjah4  7e7 ,safe and    
affordable drugs from approved countries
 ,chapter ,,viii of the ,federal ,food1 
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cha et seq47 is amended by adding at  
the end the following3  #haj4           
,importation by individuals of          
prescription drugs1 and devices1 from an
 approved country if manufacturers are  
charging an excessive price for         
comparable products in the ,united      
,states  7a7 ,in general                
,notwithstanding any other provision of 
this ,act1 not later than #ahj days     
after the date of enactment of this     
section1 the ,prescription ,drug and    
,medical ,device ,price ,review ,board  
7in this section referred to as the     
,board7 shall promulgate regulations    
permitting individuals to safely import 

from an approved country into the       
,united ,states prescription drugs1 and 
devices1 that are comparable to         
prescription drugs1 and devices1 for    
which the ,board makes a final          
determination that the manufacturer is  
charging or has charged an excessive    
price in violation of section #e7;a7 of 
the ,prescription ,drug and ,medical    
,device ,price ,review ,board ,act of   
#bjah4  7b7 ,comparable defined ,for    
purposes of this section1 the term      
comparable means-- 7#a7 with respect to 
a drug1 having the same active          
ingredient or ingredients1 route of     
administration1 dosage form1 and        
strength2 and  7#b7 with respect to a   
device1 being substantially equivalent4 
7c7 ,assurance of safety ,for purposes  
of this section1 the term approved      
country means a country that is         
determined by the ,secretary to have in 
effect standards to ensure the safety of
 prescription drugs1 and of devices1    
that are at least as protective as the  

standards applicable under ,federal law 
in the ,united ,states4  4  #g4         
,authority  7a7 ,obtaining official data
 ,the chairperson of the ,board may     
secure directly from any ,federal agency
 information necessary to enable the    
,board to carry out its duties4 ,upon   
request of the chairperson1 the head of 
the agency shall furnish such           
information to the ,board to the extent 
such information is not prohibited from 
disclosure by law4  7b7 ,mails ,the     
,board may use the ,united ,states mails
 in the same manner and under the same  
conditions as other ,federal agencies4  
7c7 ,administrative support services    
,upon the request of the chairperson of 
the ,board1 the ,administrator of       
,general ,services shall provide to the 
,board1 on a reimbursable basis1 the    
administrative support services         
necessary for the ,board to carry out   
its duties4  7d7 ,contract authority    
,the ,board may contract with and       
compensate government and private       

agencies or persons for the purpose of  
conducting research1 surveys1 and other 
services necessary to enable the ,board 
to carry out its duties4  7e7           
,investigations ,the ,board may make    
such investigations as it considers     
necessary to determine whether there is 
or may be a violation of any regulation 
promulgated under this ,act and may     
require or permit any person to file    
with it a statement in writing1 under   
oath or otherwise as the ,board shall   
determine1 as to all the facts and      
circumstances concerning the matter to  
be investigated4  7f7 ,subpoena power   
7#a7 ,in general ,the ,board may issue  
subpoenas requiring the attendance and  
testimony of witnesses and the          
production of any evidence relating to  
any matter under investigation by the   
,board4 ,the attendance of witnesses and
 the production of evidence may be      
required from any place within the      
,united ,states at any designated place 
of hearing within the ,united ,states4  

7#b7 ,failure to obey a subpoena ,if a  
person refuses to obey a subpoena issued
 under paragraph 7#a71 the ,board may   
apply to a ,united ,states district     
court for an order requiring that person
 to appear before the ,board to give    
testimony1 produce evidence1 or both1   
relating to the matter under            
investigation4 ,the application may be  
made within the judicial district where 
the hearing is conducted or where that  
person is found1 resides1 or transacts  
business4 ,any failure to obey the order
 of the court may be punished by the    
court as civil contempt4  7#c7 ,service 
of subpoenas ,the subpoenas of the      
,board shall be served in the manner    
provided for subpoenas issued by a      
,united ,states district court under the
 ,federal ,rules of ,civil ,procedure   
for the ,united ,states district courts4
  7#d7 ,service of process ,all process 
of any court to which application is    
made under paragraph 7#b7 may be served 
in the judicial district in which the   

person required to be served resides or 
may be found4  7#e7 ,notice ,upon       
issuing any subpoena under this         
subsection1 the ,board shall give notice
 of such issuance to the appropriate    
committees of ,congress1 including the  
,committee on ,appropriations of the    
,house of ,representatives and the      
,committee on ,appropriations of the    
,senate4  7g7 ,confidentiality ,nothing 
in this ,act shall be construed as      
authorizing the ,board to disclose any  
information that is a trade secret or   
confidential information subject to     
section #eeb7;b77#d7 of title #e1       
,united ,states ,code1 or section #aije 
of title #ah1 ,united ,states ,code4    
#h4 ,regulations  7a7 ,in general ,not  
later than #a year after the date of the
 initial meeting held under section     
#c7;e71 the ,board shall issue final    
regulations to carry out this ,act4  7b7
 ,notice and comment requirement ,the   
regulations developed under subsection  
7a7 shall be issued in accordance with  

the notice and comment procedures       
established under section #eec of title 
#e1 ,united ,states ,code4  #i4 ,report 
to ,federal agencies ,not later than #a 
year after the effective date of the    
regulations under section #h and        
annually thereafter1 the ,board shall   
submit to each ,federal agency that     
dispenses or makes payments for the     
dispensing of prescription drugs or     
medical devices a report containing--   
7#a7 a list of each prescription drug   
and medical device for which an         
excessive price was charged during the  
preceding calendar year1 as determined  
by the ,board under section #e2  7#b7   
recommendations to the ,federal agency  
against dispensing or making payments   
for the dispensing of the prescription  
drug or medical device2 and  7#c7       
recommendations to the ,federal agency  
to substitute1 in place of any drug or  
device listed pursuant to paragraph     
7#a71 a similar prescription drug or    
medical device that is not sold at an   

excessive price4  #aj4 ,report to       
,congress ,not later than #a year after 
the initial meeting of the ,board under 
section #c7;e71 and annually thereafter1
 the ,board shall submit to the         
,congress a report describing the       
activities of the ,board for the        
preceding year4  #aa4 ,definitions ,in  
this ,act3 7#a7 ,the term affiliate     
means1 with respect to a manufacturer1  
any entity that controls1 is controlled 
by1 or is under common control with such
 manufacturer4  7#b7 ,the term average  
manufacturer price means the average    
price charged by the manufacturer of a  
prescription drug or medical device1 as 
applicable1 for sales of the drug or    
device by the manufacturer in the       
,united ,states over the respective     
annual quarter4  7#c7 ,the term medical 
device means a device 7as defined in    
section #bja of the ,federal ,food1     
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cba774  7#d7 ,the term prescription   
drug means a drug 7as defined in section

 #bja of the ,federal ,food1 ,drug1 and 
,cosmetic ,act 7#ba ,u4,s4,c4 #cba77    
that is subject to section #ejc7;b77#a7 
of such ,act 7#ba ,u4,s4,c4             
#cec7;b77#a774