,,ii  #aacth ,,congress  #ast ,session  
,s4 #geb  ,,in ,,the ,,senate ,,of ,,the
 ,,united ,,states  ,april #ag1 #bjac   
,mrs4 ,gillibrand introduced the        
following bill2 which was read twice and
 referred to the ,committee on ,health1 
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to require the ,secretary of   
,health and ,human ,services to         
promulgate regulations regarding the    
authorship1 content1 format1 and        
dissemination of ,patient ,medication   
,information to ensure patients receive 
consistent and high-quality information 
about their prescription medications and
 are aware of the potential risks and   
benefits of prescription medications4   
#a4 ,short title ,this ,act may be cited
 as the ,cody ,miller ,initiative for   
,safer ,prescriptions ,act4  #b4        
,patient medication information for     
prescription drugs ,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;,e the following3  #eje;,f4        
,patient medication information for     
prescription drugs  7a7 ,in general ,not
 later than #b years after the date of  
enactment of this section1 the          
,secretary shall issue regulations      
regarding the authorship1 content1      
format1 and dissemination requirements  
for patient medication information      
7referred to in this section as ,,pmi7  
for drugs subject to section            
#ejc7;b77#a74  7b7 ,content ,the        
regulations promulgated under subsection
 7a7 shall require that the ,,pmi with  
respect to a drug--  7#a7 be            
scientifically accurate and based on the
 professional labeling approved by the  
,secretary and authoritative1           
peer-reviewed literature2 and  7#b7     
includes nontechnical1 understandable1  
plain language that is not promotional  
in tone or content1 and contains at     
least--  7,a7 the established name of   
drug1 including the established name of 
such drug as a listed drug 7as described

 in section #eje7;j77#b77;,a77 and as a 
drug that is the subject of an approved 
abbreviated new drug application under  
section #eje7;j7 or of an approved      
license for a biological product        
submitted under section #cea7k7 of the  
,public ,health ,service ,act1 if       
applicable2  7,b7 drug uses and clinical
 benefits2  7,c7 general directions for 
proper use2  7,d7 contraindications1    
common side effects1 and most serious   
risks of the drug1 especially with      
respect to certain groups 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   
when a patient should contact his or her
 health care professional2  7,g7        
instructions not to share medications1  
and1 if any exist1 key storage          
requirements1 and recommendations       
relating to proper disposal of any      
unused portion of the drug2 and  7,h7   
known clinically important interactions 

with other drugs and substances4  7c7   
,timeliness1 consistency1 and accuracy  
,the regulations promulgated under      
subsection 7a7 shall include standards  
related to--  7#a7 performing timely    
updates of drug information as new drugs
 and new information becomes available2 
7#b7 ensuring that common information is
 applied consistently and simultaneously
 across similar drug products and for   
drugs within classes of medications in  
order to avoid patient confusion and    
harm2 and  7#c7 developing a process1   
including consumer testing1 to assess   
the quality and effectiveness of ,,pmi  
in ensuring that ,,pmi promotes patient 
understanding and safe and effective    
medication use4  7d7 ,electronic        
repository ,the regulations promulgated 
under subsection 7a7 shall provide for  
the development of a publicly accessible
 electronic repository for all ,,pmi    
documents and content to facilitate the 
availability of ,,pmi4  4  #c4          
,publication on internet website ,the   

,secretary of ,health and ,human        
,services shall publish on the ,internet
 website of the ,food and ,drug         
,administration a link to the ,daily    
,med website                            
7http3_/_/dailymed4nlm4nih4gov_/dailymed
7 7or any successor website74