,i  #aafth ,,congress  #ast ,session    
,h4 ,r4 #eaih  ,,in ,,the ,,house ,,of  
,,representatives  ,november #bj1       
#bjai,mr4 ,golden 7for himself and ,mr4 
,carter of ,georgia7 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 regarding the
 patient medication information required
 to be included in the labeling of      
prescription drugs1 and for other       
purposes4  #a4 ,short title ,this ,act  
may be cited as the ,patients' ,right to
 ,know ,their ,medication ,act of #bjai4
  #b4 ,findings ,congress finds the     
following3  7#a7 ,prescription          
medications are important to the health 
and well-being of the ,american public4 
7#b7 ,according to the ,centers for     
,disease ,control and ,prevention       
7,,cdc71 #dh4i percent of ,americans    
used at least one prescription drug in  
the past #cj days4  7#c7 ,the           
utilization of prescription drugs can   

subject patients to adverse drug events2
 therefore1 patient safety is of the    
utmost importance4  7#d7 ,studies       
indicate that paper format patient      
medication information 7,,pmi7 can help 
protect patients and prevent the        
majority of costly adverse drug events4 
7#e7 ,in addition to bolstering patient 
safety1 the mandatory use of a          
standardized ,,pmi provided to all      
patients in nonhospital settings could  
reduce costs associated with emergency  
room visits and hospital admissions     
related to adverse drug events by #ad4f 
to #bf4b billion dollars annually4  7#f7
 ,many patients cannot access electronic
 versions of ,,pmi1 thereby             
necessitating a paper option4  7#g7 ,the
 ,government ,accountability ,office    
found that relying on electronic        
labeling as a complete substitute for   
paper labeling could adversely impact   
public health4  7#h7 ,a congressionally 
mandated paper ,,pmi is needed because  
no standardized ,,pmi in a single page1 

paper copy1 proven patient-friendly     
format is currently available to        
patients or required by the ,federal    
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cja et seq474  #c4 ,patient  
medication information for prescription 
drugs  7a7 ,in general ,chapter ,v of   
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cea et seq47 is   
amended by inserting after section      
#eje;,f 7#ba ,u4,s4,c4 #cee;g7 the      
following3  #eje;,g4 ,patient medication
 information for prescription drugs  7a7
 ,in general ,the ,secretary shall issue
 regulations on the patient medication  
information that is required to be in   
the printed labeling of drugs subject to
 section #ejc7;b77#a71 including        
regulations regarding the authorship1   
content1 format1 color1 printing1 and   
dissemination requirements for such     
patient medication information4 ,the    
,secretary shall issue final regulations
 pursuant to the preceding sentence not 
later than #a year after the date of    

enactment of this section4  7b7 ,content
 ,the regulations promulgated under     
subsection 7a7 shall require that the   
patient medication information with     
respect to a drug--  7#a7 be            
scientifically accurate1 include        
relevant patient safety information1 and
 be approved by the ,secretary2  7#b7   
include understandable plain language1  
and include graphics and pictures when  
applicable1 and be provided in a        
consistent1 standardized format and     
color for all drug products1 and not be 
promotional in tone or content1 and     
contain at least--  7,a7 the established
 name of the drug 7or1 if the drug is a 
biological product1 the proper name of  
the biological product7 and the national
 drug code for the drug2  7,b7          
indications for use approved by the     
,food and ,drug ,administration2  7,c7  
general directions for proper use2  7,d7
 contraindications1 warnings1           
precautions1 the most frequently        
occurring adverse reactions1 and adverse

 reactions that are important for other 
reasons 7such as because they are       
serious71 especially with respect to    
certain subpopulations such as children1
 pregnant women1 and the elderly2  7,e7 
measures patients may be able to take1  
if any1 to reduce the side effects and  
risks of the drug2  7,f7 information    
about when a patient should contact his 
or her health care professional2  7,g7  
instructions not to share medications1  
and1 if applicable1 key storage         
requirements and recommendations        
relating to proper disposal of any      
unused portion of the drug2  7,h7 known 
clinically important interactions with  
other drugs1 food1 and other substances2
  7,i7 a statement of whether sufficient
 data are available concerning the use  
of the drug in specified subpopulations1
 such as women1 pregnant women1         
lactating women1 women and men of       
reproductive age1 and pediatric1        
geriatric1 racial1 and ethnic minority  
groups2  7,j7 the name of the           

manufacturer and a toll-free telephone  
number for consumers to contact the     
manufacturer of the drug2 and  7,k7 a   
current link to ,form ,,fda #cejj;,b for
 voluntary reporting for consumers of   
adverse events1 product problems1 and   
product use errors 7or any successor    
form72 and  7#c7 be provided to a       
patient or agent of a patient in a      
printed format with each prescription   
dispensed1 such that a drug labeled for 
distribution shall be accompanied by    
printed labeling physically on or within
 the packaging from which the drug is to
 be dispensed1 in an adequate supply of 
printed patient medication information  
to accommodate prescriptions dispensed  
therefrom4  7c7 ,timeliness1            
consistency1 accuracy1 and effectiveness
 ,the regulations promulgated under     
subsection 7a7 shall-- 7#a7 provide for 
timely reviews1 approvals1 and updates  
of patient medication information as new
 drugs and new information become       
available2  7#b7 provide for updates    

when appropriate to help communicate    
information that is shared by similar   
products or drugs within classes of     
medication to avoid patient confusion   
and harm2  7#c7 include specifications  
for language1 graphics1 format1 color1  
and pictures required by subsection     
7b77#b71 to be developed based upon     
documented patient research with one or 
more actual drug products that          
demonstrates improved patient learning  
and understanding of safe and effective 
medication use2 and  7#d7 be based on a 
demonstrated causal connection between  
the enhanced patient medication         
information required by the regulations 
and improved patient medication         
adherence and compliance for the purpose
 of reducing the cost of health care and
 improving desired medical outcomes4  4 
7b7 ,misbranding offense ,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  7ee7 ,if it is a drug       

subject to section #ejc7;b77#a7 and     
patient medication information is not   
provided in accordance with section     
#eje;,g4  4