,,ii  #aaith ,,congress  #ast ,session  
,s4 #ceaj  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,december #af1 
#bjbe,mr4 ,budd 7for himself and ,ms4   
,hassan7 introduced the following bill2 
which was read twice and referred to the
 ,committee on ,health1 ,education1     
,labor1 and ,pensions  ,a ,,bill  ,to   
improve the inspections of drug         
establishments engaged in the           
manufacture1 preparation1 propagation1  
or processing of biosimilar biological  
products conducted by the ,food and     
,drug ,administration1 and for other    
purposes4  #a4 ,short title ,this ,act  
may be cited as the ,biosimilar         
,inspection ,modernization ,act of      
#bjbe4  #b4 ,definitions ,in this ,act--
 7#a7 the term biosimilar biological    
product means a biological product      
licensed under section #cea7k7 of the   
,public ,health ,service ,act 7#db      
,u4,s4,c4 #bfb7k772  7#b7 the term      
biosimilar biological product           
establishment means an establishment    

engaged in the manufacture1 preparation1
 propagation1 or processing of a        
biosimilar biological product and       
registered under subsection 7b77#a71    
7c77#a71 or 7i7 of section #eaj of the  
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cfj72 and  7#c7 the
 term ,secretary means the ,secretary of
 ,health and ,human ,services1 acting   
through the ,commissioner of ,food and  
,drugs4  #c4 ,public meeting and report 
on mutual recognition agreements  7a7   
,public meeting ,not later than #ahj    
days after the date of enactment of this
 ,act1 the ,secretary shall conduct a   
public meeting on the use of mutual     
recognition agreements for purposes of  
carrying out inspections under section  
#gjd of the ,federal ,food1 ,drug1 and  
,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7 of  
establishments engaged in the           
manufacture1 preparation1 propagation1  
or processing of a biosimilar biological
 product1 including a discussion of--   
7#a7 how mutual recognition agreements  

are utilized with respect to the        
inspection of biosimilar biological     
product establishments1 and areas for   
improvements in such inspections        
conducted pursuant to such agreements2  
and  7#b7 areas in which use of mutual  
recognition agreements could be expanded
 to apply beyond compliance inspections 
under section #gjd of the ,federal      
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cgd71 including for use in   
conjunction with remote regulatory      
assessments1 inspections conducted by   
trusted foreign partners identified by  
the ,food and ,drug ,administration1 and
 virtual interactions with subject      
matter experts4  7b7 ,report ,not later 
than #ahj days after the public meeting 
under subsection 7a7 is conducted1 the  
,secretary shall issue to the ,committee
 on ,health1 ,education1 ,labor1 and    
,pensions of the ,senate and the        
,committee on ,energy and ,commerce of  
the ,house of ,representatives1 and make
 publicly available1 a report that      

includes recommendations on the use of  
mutual recognition agreements for       
purposes of conducting inspections of   
biosimilar biological product           
establishments4  #d4 ,ensuring          
flexibility in inspection tools ,the    
,secretary shall update inspection      
processes and existing tools to advance 
a risk-based approach to evaluate1      
including conducting inspections1 of    
establishments engaged in the           
manufacture1 preparation1 propagation1  
or processing of biosimilar biological  
products to enable the ,food and ,drug  
,administration to-- 7#a7 increase      
utilization of remote regulatory        
assessments under section #gjd of the   
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cgd71 in accordance
 with the guidance issued by the ,food  
and ,drug ,administration1 titled       
,conducting ,remote ,regulatory         
,assessments--,questions and ,answers   
7,june #bd1 #bjbe7 7or any successor    
guidance72 and  7#b7 maximize the use of

 alternative tools set forth in the     
guidance described in paragraph 7#a7 to 
improve inspection efficiency4  #e4     
,,fda strategic plan on domestic        
inspection improvements for biosimilar  
biological facilities ,not later than #a
 year after the date of enactment of    
this ,act1 the ,secretary shall develop 
and publish a strategic plan on ways the
 ,food and ,drug ,administration will   
address challenges with respect to the  
inspection of domestic biosimilar       
biological product establishments1      
including regarding-- 7#a7 recruiting   
and retaining inspections staff2  7#b7  
challenges specific to inspecting       
domestic biosimilar biological product  
establishments2  7#c7 improving internal
 communication among all ,food and ,drug
 ,administration personnel involved in  
inspections of biosimilar biological    
product establishments2 and  7#d7       
expanding opportunities for external    
communications with sponsors of         
applications under section #cea7k7 of   

the ,public ,health ,service ,act 7#db  
,u4,s4,c4 #bfb7k771 including informing 
such sponsors about potential inspection
 requirements and resolving outstanding 
inspection related questions earlier in 
the review process4