,i  #aacth ,,congress  #b;d ,session    
,h4 ,r4 #ehgd  ,,in ,,the ,,house ,,of  
,,representatives  ,december #aa1 #bjad 
,mr4 ,israel introduced the following   
bill2 which was referred to the         
,committee on ,energy and ,commerce  ,a 
,,bill  ,to amend the ,federal ,food1   
,drug1 and ,cosmetic ,act to increase   
criminal penalties for the sale or trade
 of prescription drugs knowingly caused 
to be adulterated or misbranded1 to     
establish recall authority regarding    
drugs1 and for other purposes4  #a4     
,short title ,this ,act may be cited as 
,tim ,fagan's ,law or the ,counterfeit  
,drug ,enforcement ,act of #bjad4  #b4  
,sale or trade of prescription drugs    
knowingly caused to be adulterated or   
misbranded2 misrepresentation as        
approved drugs  7a7 ,criminal penalty   
,section #cjc7;a7 of the ,federal ,food1
 ,drug1 and ,cosmetic ,act 7#ba         
,u4,s4,c4 #ccc7;a77 is amended by adding
 at the end the following paragraphs3   
7#c7 ,notwithstanding paragraph 7#a7 or 

7#b71 in the case of a person who       
violates subsection 7a71 7b71 or 7c7 of 
section #cja with respect to a drug that
 is subject to section                  
#ejc7;b77#a77;,b71 if the person        
knowingly caused the drug to be         
adulterated or misbranded and sells or  
trades the drug1 or the person purchases
 or trades for the drug knowing or      
having reason to know that the drug was 
knowingly caused to be adulterated or   
misbranded1 the person shall be fined in
 accordance with title #ah1 ,united     
,states ,code1 or imprisoned for any    
term of years or for life1 or both4     
7#d7 ,notwithstanding paragraph 7#a7 or 
7#b71 in the case of a person who       
violates section #cja7;d7 with respect  
to a drug1 if the person caused the drug
 to be misrepresented as a drug that is 
subject to section #ejc7;b77#a77;,b7 and
 for which an approved application is in
 effect under section #eje and the      
person sells or trades the drug1 or the 
person purchases or trades for the drug 

knowing or having reason to know that   
the drug was knowingly caused to be so  
misrepresented1 the person shall be     
fined in accordance with title #ah1     
,united ,states ,code1 or imprisoned for
 any term of years or for life1 or both4
  4  7b7 ,notification of ,food and     
,drug ,administration by manufacturers  
,section #eje7k7 of the ,federal ,food1 
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee7k77 is amended by adding at the   
end the following paragraph3  7#f7 ,a   
manufacturer of a drug that receives or 
otherwise becomes aware of information  
that reasonably suggests that a         
violation described in paragraph 7#c7 or
 7#d7 of section #cjc7;a7 may have      
occurred with respect to the drug shall 
report such information to the          
,secretary not later than #dh hours     
after first receiving or otherwise      
becoming aware of the information4  4   
#c4 ,use of technologies for preventing 
counterfeiting of drugs ,section #ejb of
 the ,federal ,food1 ,drug1 and         

,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is  
amended by adding at the end the        
following3  7dd7 ,if it is a drug and it
 is not manufactured in accordance with 
any regulations of the ,secretary       
requiring the use of technologies that  
the ,secretary has determined are       
technically feasible and will assist in 
preventing violations of this ,act to   
which paragraphs 7#c7 and 7#d7 of       
section #cjc7;a7 apply 7relating to the 
knowing adulteration or misbranding of  
drugs and the knowing misrepresentation 
of drugs74  4  #d4 ,counterfeit drugs2  
increased funding for inspections1      
examinations1 and investigations ,for   
the purpose of increasing the capacity  
of the ,food and ,drug ,administration  
to conduct inspections1 examinations1   
and investigations under the ,federal   
,food1 ,drug1 and ,cosmetic ,act with   
respect to violations described in      
paragraphs 7#c7 and 7#d7 of section     
#cjc7;a7 of such ,act1 there is         
authorized to be appropriated           

#fj1jjj1jjj for each of the fiscal years
 #bjae through #bjah1 in addition to    
other authorizations of appropriations  
that are available for such purpose4    
#e4 ,public education regarding         
counterfeit drugs  7a7 ,in general ,the 
,secretary of ,health and ,human        
,services shall carry out a program to  
educate the public and health care      
professionals on counterfeit drugs1     
including techniques to identify drugs  
as counterfeit4  7b7 ,authorization of  
appropriations ,for the purpose of      
carrying out subsection 7a71 there is   
authorized to be appropriated #e1jjj1jjj
 for each of the fiscal years #bjae     
through #bjah1 in addition to other     
authorizations of appropriations that   
are available for such purpose4  #f4    
,recall authority regarding drugs       
,subchapter ,a of 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 following section3  #ejf;,g4

 ,recall authority  7a7 ,order ,to cease
 distribution of drug2 notification of  
health professionals  7#a7 ,in general  
,if the ,secretary finds that a drug    
intended for human use may constitute a 
threat to the public health1 the        
,secretary shall issue an order         
requiring the appropriate person        
7including the manufacturers1 importers1
 distributors1 or retailers of the      
drug7--  7,a7 to immediately cease      
distribution of the drug2 and  7,b7 to  
immediately notify health professionals 
of the order and to instruct such       
professionals to cease administering1   
distributing1 selling1 or prescribing   
the drug4  7#b7 ,informal hearing ,an   
order under paragraph 7#a7 shall provide
 the person subject to the order with an
 opportunity for an informal hearing1 to
 be held not later than #aj days after  
the date of the issuance of the order1  
on the actions required by the order and
 on whether the order should be amended 
to require a recall of the drug         

involved4 ,if1 after providing an       
opportunity for such a hearing1 the     
,secretary determines that inadequate   
grounds exist to support the actions    
required by the order1 the ,secretary   
shall vacate the order4  7b7 ,order ,to 
recall drug  7#a7 ,in general ,if1 after
 providing an opportunity for an        
informal hearing under subsection       
7a77#b71 the ,secretary determines that 
the order should be amended to include a
 recall of the drug with respect to     
which the order was issued1 the         
,secretary shall1 except as provided in 
paragraphs 7#b7 and 7#c71 amend the     
order to require a recall4 ,the         
,secretary shall specify a timetable in 
which the drug recall will occur and    
shall require periodic reports to the   
,secretary describing the progress of   
the recall4  7#b7 ,certain actions ,an  
amended order under paragraph 7#a7--    
7,a7 shall not require recall of a drug 
from individuals2 and  7,b7 shall       
provide for notice to individuals       

subject to the risks associated with the
 use of the drug4  7#c7 ,assistance of  
health professionals ,in providing the  
notice required by paragraph 7#b77;,b71 
the ,secretary may use the assistance of
 health professionals who administered  
the drug involved to individuals or     
prescribed the drug for individuals4 ,if
 a significant number of such           
individuals cannot be identified1 the   
,secretary shall notify such individuals
 pursuant to section #gje7;b74  4  #g4  
,authority to issue subpoenas with      
respect to preventing threats to the    
public health ,section #cjc of the      
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #ccc7;a77 is amended
 by adding at the end the following     
subsection3  7h7 ,the ,secretary and the
 ,attorney ,general shall develop and   
implement a procedure through which the 
,chief ,counsel in the ,food and ,drug  
,administration is authorized to issue  
subpoenas regarding investigations under
 this ,act of acts or omissions that may

 constitute a threat to the public      
health1 including investigations of     
alleged violations to which paragraph   
7#c7 or 7#d7 of subsection 7a7 apply and
 alleged violations with respect to     
which the ,secretary is considering the 
use of authorities under section #cjd4  
4