,,ii  #aafth ,,congress  #ast ,session  
,s4 #bgbc  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,october #bi1  
#bjai,ms4 ,collins 7for herself and ,ms4
 ,smith7 introduced the following bill2 
which was read twice and referred to the
 ,committee on ,health1 ,education1     
,labor1 and ,pensions  ,a ,,bill  ,to   
amend the ,federal ,food1 ,drug1 and    
,cosmetic ,act to reduce drug shortages1
 and for other purposes4  #a4 ,short    
title ,this ,act may be cited as the    
,mitigating ,emergency ,drug ,shortages 
,act4  #b4 ,prioritize reviews of drug  
applications2 incentives  7a7           
,prioritized reviews and inspections    
,section #ejf;,c7g7 of the ,federal     
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cef;c7g77 is amended--  7#a7 
in the matter preceding paragraph 7#a71 
by striking the ,secretary may and      
inserting the ,secretary shall2  7#b7 in
 paragraph 7#a71 by inserting prioritize
 and before expedite the review2 and    
7#c7 in paragraph 7#b71 by inserting    

prioritize and before expedite an       
inspection4  7b7 ,report ,not later than
 one year after the date of enactment of
 this ,act1 the ,secretary of ,health   
and ,human ,services shall develop and  
submit to the ,committee on ,health1    
,education1 ,labor1 and ,pensions of the
 ,senate and the ,committee on ,energy  
and ,commerce of the ,house of          
,representatives a report containing    
legislative and regulatory              
recommendations--  7#a7 to create       
market-based incentives or other        
appropriate mechanisms1 sufficient to   
encourage--  7,a7 the manufacture of    
drugs in shortage or at risk of         
shortage2  7,b7 the domestic manufacture
 of finished dosage forms of such drugs2
 and  7,c7 the domestic manufacture of  
active pharmaceutical ingredients for   
such drugs2 and  7#b7 to expand the     
,emerging ,technology ,program of the   
,food and ,drug ,administration to      
create or upgrade existing technologies 
to address drug shortage challenges and 

promote modern1 reliable manufacturing  
strategies4  #c4 ,additional            
manufacturer reporting requirements in  
response to drug shortages  7a7         
,expansion ,to include active           
pharmaceutical ingredients ,subsection  
7a7 of section #ejf;,c of the ,federal  
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cef;c7 is amended--  7#a7 in 
the matter preceding paragraph 7#a71 by 
inserting or its active pharmaceutical  
ingredients after a drug2 and  7#b7 in  
the flush text at the end--  7,a7 by    
inserting or its active pharmaceutical  
ingredients before that is likely2  7,b7
 or its active pharmaceutical           
ingredients after that drug2 and  7,c7  
by adding at the end the following3     
,notification under this subsection     
shall include full disclosure of the    
problems resulting in the shortage1 the 
source of the active pharmaceutical     
ingredient1 associated medical devices  
used for preparation or administration  
included in the finished dosage form1   

any alternative sources for the active  
pharmaceutical ingredient that are known
 or contacted by manufacturer1          
information concerning the extent of the
 shortage1 the expected duration of the 
shortage1 the expected impact to        
distribution and availability in        
pharmacies1 and such other information  
as the ,secretary may require44  7b7    
,manufacturing reporting ,section       
#ejf;,c of the ,federal ,food1 ,drug1   
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#cef;c7 is amended by adding at the end 
the following3  7j7 ,manufacturer       
reporting ,each manufacturer of a drug  
described in subsection 7a7 or of any   
active pharmaceutical ingredient or     
associated medical devices used for     
preparation or administration included  
in the finished dosage form of such a   
drug1 shall report in such              
manufacturer's annual establishment     
registration and product listing under  
subsections 7b7 and 7j7 of section #eaj 
the specific facilities in which such   

drug or ingredient is manufactured and  
contingency and redundancy plans to help
 ensure uninterrupted supply of the drug
 or ingredient4 ,additional manufacturer
 reporting requirements under this      
section shall be maintained by the      
,secretary in a confidential and        
internal manner for use by the agency to
 help ensure continued supply of such   
drugs4  4  7c7 ,consumer notification   
,not later than one year after the date 
of enactment of this ,act1 the          
,secretary shall develop and submit to  
the ,committee on ,health1 ,education1  
,labor1 and ,pensions of the ,senate and
 the ,committee on ,energy and ,commerce
 of the ,house of ,representatives      
legislative and regulatory              
recommendations for consumer            
notification in the case of a drug      
shortage1 discontinuance1 or            
interruption of the manufacture of a    
drug described in section #ejf;,c7a7 of 
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cef;c7a771        

including recommendations for           
notification to patients and physicians1
 pharmacists1 and other practitioners   
authorized under applicable ,state law  
to prescribe or dispense drugs4  7d7    
,reporting after factory inspections    
,section #gjd7;b7 of the ,federal ,food1
 ,drug1 and ,cosmetic ,act 7#ba         
,u4,s4,c4 #cgd7;b77 is amended-- 7#a7 by
 redesignating paragraphs 7#a7 and 7#b7 
and subparagraphs 7,a7 and 7,b72  7#b7  
by striking 7b7 ,upon completion and    
inserting 7b77#a7 ,upon completion2 and 
7#c7 by adding at the end the following3
  7#b7 ,in carrying out this subsection 
with respect to any establishment       
manufacturing a drug approved under     
subsection 7c7 or 7j7 of section #eje   
that is described in #ejf;,c7a7 or      
#eje7;j77#aa77;,a71 a copy of the report
 shall be sent promptly to the          
appropriate offices of the ,food and    
,drug ,administration with expertise    
regarding drug shortages4 ,such offices 
shall ensure timely and effective       

coordination regarding the reviews of   
such report and overseeing the alignment
 of any feedback regarding such report1 
or corrective or preventative actions1  
after consideration of the systematic   
benefits and risks to public health1    
patient safety1 the drug supply and drug
 supply chain1 and timely patient access
 to such drugs4  4  7e7 ,effective date 
,the amendments made by this section and
 section #b shall take effect on the    
date that is #ahj days after the date of
 enactment of this ,act4  #d4 ,,gao     
report on intra-agency coordination  7a7
 ,in general ,not later than #ah months 
after the date of enactment of this     
,act1 the ,comptroller ,general of the  
,united ,states shall submit to the     
,committee on ,health1 ,education1      
,labor1 and ,pensions of the ,senate and
 the ,committee on ,energy and ,commerce
 of the ,house of ,representatives a    
report examining the ,food and ,drug    
,administration's intra-agency          
coordination1 communication1 and        

decision making in assessing drug       
shortage risks1 and taking corrective   
action4  7b7 ,content ,the report shall 
include-- 7#a7 consideration of--  7,a7 
risks associated with violations of     
current good manufacturing practices2   
7,b7 corrective and preventative actions
 with respect to such violations        
requested by the ,food and ,drug        
,administration2  7,c7 the effects of   
potential manufacturing slow-downs or   
shut-downs on potential drug shortages1 
including the discontinuance of drug    
manufacturing and marketing2  7,d7      
efforts to prioritize review of         
applications for drugs that the         
,secretary has determined under section 
#ejf;,e of the ,federal ,food1 ,drug1   
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#cef;e7 to be in shortage2 and  7,e7    
efforts to prioritize inspections of    
facilities necessary for approval of    
applications for drugs described in     
subparagraph 7,d72  7#b7 a description  
of how the ,food and ,drug              

,administration proactively coordinates 
strategies to mitigate the consequences 
of the violations1 slow-downs1 and      
shut-downs described in paragraph 7#a7  
across agencies2 and  7#c7 an evaluation
 of changes in relevant ,food and ,drug 
,administration practices that such     
agency has proposed but not yet         
implemented4  #e4 ,modifications to drug
 shortage list maintained by ,,fda  7a7 
,in general ,section #ejf;,e of the     
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cef;e7 is amended--
  7#a7 in subsection 7a71 by striking   
the period and inserting the following3 
1 by region1 including ,states and      
localities1 where the shortages exist4  
,the ,secretary may enter into a        
private-public partnership to maintain  
such list42 and  7#b7 in subsection     
7b77#c77;,c71 by inserting before the   
period the following3 1 strength1 or    
dosage form4  7b7 ,effective date ,the  
amendments made by subsection 7a7 shall 
take effect on the date of enactment of 

this ,act1 and shall apply to updates   
made to the drug shortage list under    
section #ejf;,e of the ,federal ,food1  
,drug1 and ,cosmetic ,act after the date
 of enactment of this ,act4  #f4        
,national security risk assessment of   
drug1 active pharmaceutical ingredient  
and medical device manufacturing        
operations  7a7 ,assessment and report  
7#a7 ,in general ,the ,secretary of     
,health and ,human ,services1 in        
collaboration with the ,secretary of    
,homeland ,security and in consultation 
with stakeholders 7including            
pharmacists1 hospitals1 physicians1 and 
pharmaceutical and medical device       
manufacturers71 shall conduct a risk    
assessment of national security threats 
arising from1 or related to1 the        
manufacture and distribution of drugs   
described in #ejf;,c7a7 of the ,federal 
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cef;c7a77 or of any active   
pharmaceutical ingredients of such drugs
 or associated medical devices used for 

preparation or administration of such   
drugs4 ,not later than #ah months after 
the date of enactment of this ,act1 the 
,secretary shall submit to the          
,committee on ,health1 ,education1      
,labor1 and ,pensions of the ,senate and
 the ,committee on ,energy and ,commerce
 of the ,house of ,representatives a    
report outlining findings under such    
assessment and any recommended actions4 
7#b7 ,content ,the assessment and report
 under paragraph 7#a7 shall include--   
7,a7 a review of manufacturing and      
distribution of drugs described in such 
section #ejf;,c7a71 active              
pharmaceutical ingredients of such      
drugs1 and associated medical devices   
used for preparation or administration  
of such drugs1 that includes            
consideration of whether manufacturing  
sites and distribution systems should be
 considered critical infrastructure 7as 
defined in section #ajaf7;e7 of the     
,critical ,infrastructures ,protection  
,act of #bjja 7#db ,u4,s4,c4            

#eaie;c7e7772  7,b7 a review of risks   
associated with the foreign manufacture 
of such drugs1 ingredients1 or devices2 
and  7,c7 recommendations on how to     
mitigate any such risks4  7b7 ,standing 
forum ,the ,secretary of ,health and    
,human ,services1 in collaboration with 
the ,secretary of ,homeland ,security1  
shall establish a standing forum to     
engage stakeholders1 including          
pharmacists1 hospitals1 physicians1 and 
pharmaceutical and medical device       
manufacturers1 to mitigate risks        
identified through the assessment       
conducted under subsection 7a74