,,ii  #aaith ,,congress  #ast ,session  
,s4 #bjbg  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,june #aa1     
#bjbe,mr4 ,mullin 7for himself and ,mr4 
,booker7 introduced the following bill2 
which was read twice and referred to the
 ,committee on ,health1 ,education1     
,labor1 and ,pensions  ,a ,,bill  ,to   
provide for digital communication of    
prescribing information for drugs       
7including biological products71 and for
 other purposes4  #a4 ,short title ,this
 ,act may be cited as the ,prescription 
,information ,modernization ,act of     
#bjbe4  #b4 ,digital communication of   
,,fda-approved prescribing information  
for drugs 7including biological         
products7  7a7 ,in general ,section     
#ejb7;f7 of the ,federal ,food1 ,drug1  
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#ceb7;f77 is amended by adding at the   
end the following3 ,required prescribing
 information for drugs subject to       
section #ejc7;b77#a7 may be made        
available solely by electronic means1   

provided that the labeling complies with
 all applicable requirements of law1    
that the manufacturer affords           
prescribers and dispensers the          
opportunity to elect to also continue to
 receive all such information in paper  
form or to request paper labeling on an 
as-needed basis1 and1 after such        
request1 that the manufacturer promptly 
provides the requested information      
without additional cost44  7b7          
,rulemaking  7#a7 ,in general ,not later
 than #a year after the date of the     
enactment of this ,act1 the ,secretary  
of ,health and ,human ,services shall   
issue final regulations to-- 7,a7       
implement the amendment made by         
subsection 7a72 and  7,b7 provide       
instructions on how health care         
professionals can receive paper copies  
of prescribing information directly from
 the manufacturer or distributor if     
desired4  7#b7 ,economic impacts ,the   
,secretary of ,health and ,human        
,services shall design the regulations  

required by paragraph 7#a7 so as to     
minimize the adverse economic impacts of
 such regulations on prescribers and    
dispensers4  7c7 ,public workshop ,not  
later than #b years after the date of   
the enactment of this ,act1 the         
,secretary of ,health and ,human        
,services1 acting through the           
,commissioner of ,food and ,drugs1 shall
 hold a public workshop with relevant   
stakeholders to discuss how to continue 
to optimize the format1 accessibility1  
and usability of prescribing            
information4  7d7 ,effective date ,the  
amendment made by subsection 7a7 shall  
apply with respect to drugs introduced  
or delivered for introduction into      
interstate commerce on or after the     
sooner of-- 7#a7 the date that is #b    
years after the date of the enactment of
 this ,act2 or  7#b7 the effective date 
of the final regulations promulgated to 
implement such amendment4  7e7          
,definition ,in this section1 the term  
drug has the meaning given to such term 

in section #bja of the ,federal ,food1  
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cba74