,,ii  #aafth ,,congress  #b;d ,session  
,s4 #dage  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,july #b1      
#bjbj,ms4 ,warren 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   
secure the supply of drugs in the       
,united ,states1 and for other purposes4
  #a4 ,short title ,this ,act may be    
cited as the ,pharmaceutical ,supply    
,chain ,defense and ,enhancement ,act4  
#b4 ,listing of critical drugs  7a7 ,in 
general ,not later than #a year after   
the date of enactment of this ,act1 the 
,secretary1 acting through the          
,commissioner of ,food and ,drugs and in
 consultation with the ,secretary of    
,defense1 shall develop a confidential  
list of drugs such ,secretary determines
 to be critical to the public health or 
national security4 ,such list shall     
include the name of each such drug1 as  
well as all active pharmaceutical       

ingredients and starting materials      
required for the manufacture of the     
drug4 ,in developing the list1 the      
,secretary may consider the role of     
shortages in impeding access to drugs4  
7b7 ,updates ,the ,secretary shall      
update the list described in subsection 
7a7 not less frequently than once every 
#b years4  7c7 ,submission of list ,the 
,secretary shall submit the list        
described in subsection 7a71 including  
any updates to such list under          
subsection 7b71 as a classified matter1 
to the ,committee on ,health1           
,education1 ,labor1 and ,pensions1 the  
,committee on ,armed ,services1 the     
,committee on ,foreign ,relations1 and  
the ,committee on ,banking1 ,housing1   
and ,urban ,affairs of the ,senate1 and 
to the ,committee on ,energy and        
,commerce1 the ,committee on ,armed     
,services1 the ,committee on ,foreign   
,affairs1 and the ,committee on         
,financial ,services of the ,house of   
,representatives4  7d7 ,interim list    

,during the period between the date of  
enactment of this ,act and the date on  
which the ,secretary issues the first   
list under subsection 7a71 the          
,secretary1 in consultation with the    
,commissioner of ,food and ,drugs1 the  
,secretary of ,defense1 and the         
,assistant ,secretary for ,preparedness 
and ,response1 shall establish an       
interim list of drugs that will be      
deemed the list under subsection 7a7    
until the ,secretary develops the first 
list under subsection 7a74 ,such interim
 list shall include not fewer than #cj  
drugs1 as well as the active            
pharmaceutical ingredients and starting 
materials required for the manufacture  
of such drugs1 that are-- 7#a7 included 
on the most recent list of essential    
medicines issued by the ,world ,health  
,organization2 or  7#b7 countermeasures 
and products that could replenish the   
strategic national stockpile4  7e7      
,comment period ,not later than #fj days
 prior to the submission of the list    

described in subsection 7a71 the        
,secretary shall establish a comment    
period during which the public may      
comment on which drugs should be        
included on the list under subsection   
7a74  #c4 ,boosting domestic drug and   
active ingredient manufacturing capacity
  7a7 ,in general ,the ,secretary1      
acting through the ,director of the     
,biomedical ,advanced ,research and     
,development ,authority1 shall increase 
the domestic capacity to manufacture    
active pharmaceutical ingredients and   
starting materials for drugs critical to
 the public health and national security
 by entering into the contracts         
described in subsection 7b74  7b7       
,contracts  7#a7 ,in general ,to carry  
out subsection 7a71 the ,secretary shall
 enter into contracts1 not later than #f
 months after the date of enactment of  
this ,act1 as follows3 7,a7 ,the        
,secretary shall enter into contracts   
with companies and nonprofit entities   
headquartered in the ,united ,states1   

under which such companies use          
manufacturing establishments located in 
the ,united ,states to manufacture the  
drugs included on the list under section
 #b1 and the requisite active           
pharmaceutical ingredients and starting 
materials of such drugs1 using advanced 
manufacturing1 including continuous     
manufacturing where applicable4  7,b7   
,as a condition for entering into       
contracts with the ,secretary to        
manufacture drugs1 companies and        
nonprofit entities shall-- 7i7 develop  
and maintain a redundancy risk          
management and continuity of business   
plan 7reviewed and approved by the      
,secretary7 that identifies and         
evaluates risks to the supply of the    
drug1 as applicable1 for each           
establishment in which such drug1 and   
the requisite active pharmaceutical     
ingredients and starting materials of   
such drug1 is manufactured2  7ii7 commit
 to implementing1 as appropriate1 risk  
management and other strategies to      

ensure that1 in the case of potential   
supply chain disruptions1 the entity can
 continue normal production of the drug1
 and the requisite active pharmaceutical
 ingredients and starting materials of  
such drug1 for #ah months2  7iii7 commit
 to maintaining1 to the extent          
practicable 7as determined by the       
,secretary7 for each drug1 and the      
requisite active pharmaceutical         
ingredients and starting materials of   
such drug1 a #c-month supply in order to
 mitigate the impact of supply chain    
disruptions and shortages2  7iv7 commit 
to selling drugs1 or the requisite      
active pharmaceutical ingredients and   
starting materials of such drugs1       
developed under contract with the       
,secretary at fair and reasonable       
prices1 as determined by the ,secretary1
 taking into consideration-- 7,i7 the   
impact of price on patient access to the
 drug2  7,,ii7 the cost of the drug to  
,federal or ,state health programs2     
7,,iii7 the cost of manufacturing the   

drug2 and  7,,iv7 the impact of price on
 market competition for the drug2 and   
7v7 commit to making the prices         
described in clause 7iv7 public4  7,c7  
,the contracts described in this        
paragraph shall contain continuity of   
business agreements demonstrating1 in   
advance of receiving a contract1 the    
company's ability to rapidly begin      
production4  7,d7 ,the ,secretary shall 
enter into contracts only with companies
 headquartered in the ,united ,states   
that use manufacturing establishments   
located in the ,united ,states1 under   
which such companies expand the         
capabilities of continuous manufacturing
 and other advanced manufacturing for   
the production of the active            
pharmaceutical ingredients and starting 
materials for the drugs included on the 
list under section #b4  7,e7 ,in issuing
 contracts under this section1 the      
,secretary shall prioritize-- 7i7       
contracts designed to enhance the supply
 of generic drugs and biosimilar        

biological products and the requisite   
active pharmaceutical ingredients and   
starting materials of such generic drugs
 and biosimilar products2 and  7ii7     
contracts designed to enhance the supply
 of drugs1 and the requisite active     
pharmaceutical ingredients and starting 
materials of such drugs1 that are not   
currently manufactured in the ,united   
,states4  7#b7 ,inspector ,general      
review ,the ,inspector ,general of the  
,department of ,health and ,human       
,services shall conduct a review of not 
fewer than #a of every #c contracts     
entered into under this section1 and of 
the entities entering into such         
contracts1 to ensure that contracts are 
being issued under fair and reasonable  
terms and conditions1 including         
facilitating the procurement by the     
,federal ,government of applicable      
products under section #b and applicable
 drugs1 biological products1 and medical
 devices at fair and reasonable prices4 
,the ,inspector ,general shall make each

 such review public and1 in cases where 
such a review identifies unreasonable   
prices1 submit recommendations to       
,congress on how the ,office should     
improve its contracting systems to      
ensure reasonable pricing4  7#c7        
,funding ,to carry out this section1    
there are authorized to be appropriated 
#e1jjj1jjj1jjj for the period of fiscal 
years #bjbj and #bjbd4 ,not later than  
,april #a1 #bjbd1 the ,secretary shall  
report to the congressional committees  
listed under section #b7;c7 of this     
,act1 and provide a recommendation for  
renewal of funding under this paragraph4
  7c7 ,federal procurement of           
domestically manufactured drugs  7#a7   
,procurement of drugs  7,a7 ,in general 
,beginning in fiscal year #bjbd1 when   
purchasing any drug included on the list
 under section #b1 the ,secretary of    
,defense1 the ,secretary of ,veterans   
,affairs1 the ,director of the ,bureau  
of ,prisons1 and1 for purposes of       
maintaining the strategic national      

stockpile1 the ,secretary of ,health and
 ,human ,services1 shall give priority  
to supplies of the drug manufactured in 
the ,united ,states 7including all      
active pharmaceutical ingredient and    
starting materials of the drug7 that is 
of high quality4  7,b7 ,use of remaining
 funds ,in the case that a ,federal     
agency described in this paragraph that1
 after purchasing all drugs on the list 
under section #b needed by such agency  
for a fiscal year1 has funds            
appropriated under paragraph 7#b7 for   
that fiscal year remaining1 such        
,federal agency may use the remaining   
funds to purchase drugs wholly          
manufactured in the ,united ,states that
 are not included on the list under     
section #b4  7#b7 ,funding  7,a7 ,in    
general ,there are authorized to be     
appropriated to each of the ,secretary  
of ,defense1 the ,secretary of ,veterans
 ,affairs1 the ,bureau of ,prisons1 and 
the ,secretary of ,health and ,human    
,services1 #a1jjj1jjj1jjj for the period

 of fiscal years #bjbd and #bjbh1 to be 
used to purchase drugs manufactured in  
the ,united ,states1 as described in    
paragraph 7#a74  7,b7 ,reversion ,all   
funds that are appropriated under this  
paragraph for a fiscal year1 but not    
expended by the end of the fiscal year1 
shall revert to the ,general ,fund of   
the ,treasury4  7,c7 ,no diversion or   
transfer of funds ,no funding           
appropriated under this section shall be
 diverted1 transferred1 or otherwise    
made available for purposes beyond what 
is described in this ,act4  7#c7 ,,nih  
authorization ,there are authorized to  
be appropriated to the ,director of the 
,national ,institutes of ,health1 for   
each fiscal year for which amounts are  
appropriated under paragraph 7#b7 but   
not expended in full1 an amount equal to
 the amount that reverts to the         
,treasury for such year1 as described in
 paragraph 7#b74 ,such amounts shall be 
used by the ,director of the ,national  
,institutes of ,health to carry out     

biomedical research4  #d4 ,supply chain 
transparency  7a7 ,domestic suppliers to
 ,federal programs ,each domestic       
manufacturer of a drug that supplies    
such drug to the ,department of         
,defense1 the ,department of ,veterans  
,affairs1 the ,department of ,health and
 ,human ,services1 or the ,bureau of    
,prisons1 or a domestic manufacturer of 
an active ingredient of a drug so       
supplied1 shall-- 7#a7 report annually  
to the ,secretary and the agency        
receiving such drug on-- 7,a7 whether   
any ingredients of such drug is sourced1
 either wholly or in part1 from a       
foreign country2  7,b7 in the case of an
 active pharmaceutical ingredient or key
 starting material that the manufacturer
 procures from a single source in a     
single foreign country1 as applicable-- 
7i7 not less than #b alternative sources
 of any active pharmaceutical ingredient
 or key starting material2  7ii7 #a such
 alternative source1 if only #a such    
alternative source is available2 or     

7iii7 a statement that no such          
alternative sources are available2 and  
7,c7 an assessment of the resilience and
 capacity of the alternate sources      
identified under subparagraph 7,b72 and 
7#b7 develop continuity of business     
plans to prevent the disruption of any  
drug listed under section #b1 including 
any active or inactive ingredients of   
such drug1 which the ,secretary may     
audit4  7b7 ,foreign drug suppliers     
7#a7 ,establishments in a foreign       
country ,section #eaj7;i7 of the        
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cfj7;i77 is amended
 by inserting at the end the following3 
7#e7 ,the requirements of paragraphs    
7#a7 and 7#b7 shall apply to            
establishments within a foreign country 
engaged in the manufacture1 preparation1
 propagation1 compounding1 or processing
 of any drug that is required to be     
listed pursuant to subsection 7j71 or of
 any active pharmaceutical ingredient of
 such a drug4 ,such requirements shall  

apply regardless of whether the drug or 
active pharmaceutical ingredient        
undergoes further manufacture1          
preparation1 propagation1 compounding1  
or processing at a separate             
establishment or establishments outside 
the ,united ,states prior to being      
imported or offered for import into the 
,united ,states4  4  7#b7 ,listing of   
drugs ,section #eaj7;j77#a7 of the      
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cfj7;j77#a77 is    
amended-- 7,a7 in subparagraph 7,d71 by 
striking and at the end2  7,b7 in       
subparagraph 7,e71 by striking the      
period at the end and inserting 2 and2  
and  7,c7 by adding at the end the      
following new subparagraph3  7,f7 in the
 case of a drug contained in the        
applicable list1 a certification that   
the registrant has-- 7i7 identified     
every other establishment where         
manufacturing is performed for the drug 
by the registrant2 and  7ii7 notified   
each known foreign establishment engaged

 in the manufacture1 preparation1       
propagation1 compounding1 or processing 
of the drug or the active pharmaceutical
 ingredient of the drug of the inclusion
 of the drug in the list and the        
obligation to register pursuant to      
subsection 7i77#e74  4  7c7 ,reports to 
,congress and the public  7#a7          
,classified report to ,congress ,not    
later than #a year after the date of    
enactment of this ,act and annually     
thereafter1 the ,secretary1 in          
consultation with the ,secretary of     
,defense1 shall submit a classified     
report to ,congress on the ,nation's    
reliance on importation of active and   
inactive ingredients of drugs included  
on the list under section #b4  7#b7     
,public reports ,not later than #a year 
after the date of enactment of this ,act
 and annually thereafter1 the           
,secretary1 in consultation with the    
,secretary of ,defense1 shall prepare an
 unclassified summary of the report     
described in paragraph 7#a71 and shall  

make such summary publicly available on 
the internet websites of the ,department
 of ,health and ,human ,services and the
 ,department of ,defense for purposes of
 understanding the ,nation's dependency 
on foreign manufacturers of drugs4 ,such
 summaries shall not include the names  
of any drugs1 active pharmaceutical     
ingredients1 or starting materials4     
7#c7 ,content ,the reports under        
paragraph 7#a7 shall include-- 7,a7 all 
brand name and generic drugs1 and the   
active and inactive ingredients of such 
drugs that-- 7i7 are not wholly produced
 in the ,united ,states2  7ii7 are      
exclusively produced1 or utilize active 
or inactive ingredients produced abroad2
  7iii7 are critical to the public      
health and national security of the     
people of the ,united ,states1 as       
determined by the ,secretary1 in        
consultation with the ,secretary of     
,defense1 and including any drugs       
included in the list under section #b2  
or  7iv7 are procured in any quantity by

 the ,department of ,defense for use by 
service members or veterans or by the   
,department of ,health and ,human       
,services for the strategic national    
stockpile2  7,b7 a list of potential1   
alternative sources for any finished    
drug or active or inactive ingredient of
 a drug1 that is sourced from a single  
manufacturer with establishments in the 
,united ,states2 and  7,c7 assess the   
resiliency and capacity of alternative  
sources of any drug described in        
subparagraph 7,a71 and whether any such 
alternative source could be relied on to
 support domestic demand for such drug4 
7d7 ,manufacturer compliance  7#a7      
,failure to notify of a permanent       
discontinuance or an interruption       
,section #cja of the ,federal ,food1    
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cca7 is amended by adding at the end  
the following3  7fff7 ,the failure of a 
manufacturer of a drug described in     
section #ejf;,c7a71 or an active        
pharmaceutical ingredient of such a     

drug1 to notify the ,secretary of a     
permanent discontinuance or an          
interruption1 and the reasons for such  
discontinuance or interruption1 as      
required by section #ejf;,c4  4  7#b7   
,exemption from penalty ,section        
#cjc7;c7 of the ,federal ,food1 ,drug1  
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#ccc7;c77 is amended by inserting before
 the period at the end the following3 or
 7#f7 for having violated section       
#cja7;fff7 if such person made a good   
faith determination that the            
discontinuance or interruption was not  
likely to lead to a meaningful          
disruption in the supply of that drug in
 the ,united ,states4  7e7 ,registry of 
active ingredients ,there is authorized 
to be appropriated to the ,secretary of 
,health and ,human ,services #bj1jjj1jjj
 for fiscal year #bjba1 for purposes of 
establishing1 in consultation with the  
,commissioner of ,food and ,drugs1 an   
online registry of active pharmaceutical
 ingredients and key starting materials 

using information reported under        
subsection 7a7 and pursuant to a        
registration under section #eaj7;i7 of  
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cfj7;i774  7f7    
,food and ,drug ,administration         
inspections ,there are authorized to be 
appropriated such funds as may be       
necessary to ensure that the            
,commissioner of ,food and ,drugs is    
able to conduct inspections and         
evaluations of new establishments       
established using funds made available  
under this ,act4  #e4 ,oversight of     
foreign pharmaceutical investment  7a7  
,in general ,not later than #a year     
after the date of the enactment of this 
,act1 and annually thereafter1 the      
,federal ,trade ,commission1 in         
consultation with the ,secretary of the 
,treasury acting through the ,committee 
on ,foreign ,investment in the ,united  
,states 7referred to in this section as 
the ,committee71 shall submit to the    
appropriate congressional committees1   

the ,secretary of ,health and ,human    
,services1 and the ,commissioner of     
,food and ,drugs1 a report on foreign   
investment in the pharmaceutical        
industry of the ,united ,states4  7b7   
,elements ,the report required by       
subsection 7a7 shall include the        
following3 7#a7 ,an assessment of-- 7,a7
 the supply chain of the pharmaceutical 
industry of the ,united ,states and the 
effect of concentration and reliance on 
foreign manufacturing within that       
industry2  7,b7 the effect of foreign   
investment in the pharmaceutical        
industry of the ,united ,states on      
domestic capacity to produce drugs and  
active and inactive ingredients of      
drugs2 and  7,c7 the effect of foreign  
investment in technologies or other     
products for sequencing or storage of   
,,dna1 including genome and exome       
analysis1 in the ,united ,states1       
including the effect of such investment 
on the capacity to sequence or store    
,,dna in the ,united ,states4  7#b7 ,the

 number of reviews and investigations   
conducted by the ,committee1 in each of 
the #aj fiscal years preceding the year 
in which the study is conducted1 with   
respect to covered transactions 7as     
defined in section #gba7;a7 of the      
,defense ,production ,act of #aiej 7#ej 
,u4,s4,c4 #defe7;a777-- 7,a7 in the     
pharmaceutical industry of the ,united  
,states2 or  7,b7 relating to the       
sequencing or storage of ,,dna in the   
,united ,states4  7#c7 ,a short         
description of each such review or      
investigation1 including whether the    
transaction was approved or prohibited4 
7c7 ,authority ,the ,federal ,trade     
,commission shall have authority under  
section #f of the ,federal ,trade       
,commission ,act 7#ae ,u4,s4,c4 #df7 to 
conduct the studies required to prepare 
the report required by subsection 7a74  
7d7 ,publication ,the ,federal ,trade   
,commission shall publish an            
unclassified summary of the report      
required by subsection 7a7 on a publicly

 available internet website of the      
,commission4  7e7 ,appropriate          
congressional committees defined ,in    
this section1 the term appropriate      
congressional committees means-- 7#a7   
the ,committee on ,banking1 ,housing1   
and ,urban ,affairs1 the ,committee on  
,health1 ,education1 ,labor1 and        
,pensions1 the ,committee on ,armed     
,services1 the ,committee on ,foreign   
,relations1 the ,committee on ,commerce1
 ,science1 and ,transportation1 and the 
,committee on ,appropriations of the    
,senate2 and  7#b7 the ,committee on    
,financial ,services1 the ,committee on 
,energy and ,commerce1 the ,committee on
 ,armed ,services1 the ,committee on    
,foreign ,affairs1 and the ,committee on
 ,appropriations of the ,house of       
,representatives4  #f4 ,definitions ,in 
this ,act-- 7#a7 advanced manufacturing 
means an approach for the manufacturing 
of pharmaceuticals that incorporates    
novel technology1 or uses an established
 technique or technology in a new or    

innovative way 7such as continuous      
manufacturing where the input materials 
are continuously transformed within the 
process by #b or more unit operations71 
that enhances drug quality or improves  
the manufacturing process2  7#b7 the    
term continuous manufacturing-- 7,a7    
means a process where the input         
materials are continuously fed into and 
transformed within the process1 and the 
processed output materials are          
continuously removed from the system2   
and  7,b7 consists of an integrated     
process that consists of a series of #b 
or more unit operations2  7#c7 the term 
drug has the meaning given such term in 
section #bja7;g7 of the ,federal ,food1 
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cba7;g772  7#d7 the term ,secretary1  
unless otherwise specified1 means the   
,secretary of ,health and ,human        
,services2  7#e7 the term starting      
material means a raw material1          
intermediate1 or a drug substance that  
is used in the production of a drug     

substance and that is incorporated as a 
significant structural fragment into the
 structure of the drug substance2 and   
7#f7 the term strategic national        
stockpile means the stockpile maintained
 by the ,secretary under section        
#cai;,f-#b of the ,public ,health       
,service ,act 7#db ,u4,s4,c4            
#bdg;d-#f;b74