,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #debe  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,july #ag1 #bjbe,ms4  
,ross 7= h]self1 ,ms4 ,s*ri]1 ,ms4      
,ca/or ( ,florida1 ,mrs4 ,trahan1 &     
,mrs4 ,flet*]7 introduc$ ! foll[+ bill2 
:i* 0 ref]r$ to ! ,committee on ,en]gy &
 ,comm]ce  ,a ,,bill  ,to protect an    
individuals ability to access m$ic9es   
approv$ by ! ,food & ,drug ,adm9i/ration
 to protect a heal? c>e provid]s ability
 to provide su* m$ic9es1 & in=mation    
relat$ to su* m$ic9es4  #a4 ,%ort title 
,?is ,act may be cit$ z ! ,"r to        
,,fda-,approv$ ,m$ic9es ,act4  #b4      
,def9itions ,9 ?is ,act3  7#a7          
,,fda-approv$ m$ic9e ,! t]m             
,,fda-approv$ m$ic9e means any drug     
approv$ "u section #eje ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7 or lic5s$ "u section    
#cea ( ! ,public ,heal? ,s]vice ,act    
7#db ,u4,s4,c4 #bfb74  7#b7 ,gov]nm5t ,!
 t]m gov]nm5t includes ea* bran*1       
dep>tm5t1 ag5cy1 in/rum5tality1 &       

(ficial ( ! ,unit$ ,/ates or a ,/ate4   
7#c7 ,heal? c>e provid] ,! t]m heal? c>e
 provid] means any entity or individual 
7includ+ any physician1 c]tifi$         
nurse-midwife1 nurse1 nurse practition]1
 physician assi/ant1 & ph>maci/7 t is   
lic5s$ or o!rwise au?oriz$ by a ,/ate to
 prescribe ,,fda-approv$ m$ic9es4  7#d7 
,/ate ,! t]m ,/ate includes ea* ( ! #ej 
,/ates1 ! ,di/rict ( ,columbia1 !       
,commonweal? ( ,pu]to ,rico1 & ea*      
t]ritory & possession ( ! ,unit$ ,/ates1
 & any political subdivision ( any ( !  
=ego+1 includ+ any unit ( local         
gov]nm5t1 su* z a c\nty1 city1 t[n1     
village1 or o!r g5]al purpose political 
subdivision ( a ,/ate4  #c4 ,purposes ,!
 purposes ( ?is ,act are-- 7#a7 to      
provide a cle> & compreh5sive "r to     
,,fda-approv$ m$ic9es2 &  7#b7 to p]mit 
individuals to seek & obta9             
,,fda-approv$ m$ic9es & to p]mit heal?  
c>e provid]s to facilitate prescrib+ su*
 m$ic9es4  #d4 ,p]mitt$ s]vices  7a7 ,9 
g5]al ,an individual has a /atutory "r  

"u ?is ,act to obta9 ,,fda-approv$      
m$ic9es free f co]cion1 & a heal? c>e   
provid] has a correspond+ "r to provide 
,,fda-approv$ m$ic9es1 & in=mation1     
ref]rals1 & s]vices relat$ to su*       
m$ic9es4  7b7 ,limitations or           
requirem5ts ,! /atutory rights specifi$ 
9 subsection 7a7 %all n be limit$ or    
o!rwise infr+$ ?r\gh any limitation or  
requirem5t t-- 7#a7 expressly1          
effectively1 implicitly1 or z-implem5t$ 
s+les out--  7,a7 ! provision (         
,,fda-approv$ m$ic9es1 or in=mation     
relat$ to su* m$ic9es2  7,b7 heal? c>e  
provid]s :o provide ,,fda-approv$       
m$ic9es or in=mation relat$ to su*      
m$ic9es2 or  7,c7 facilities 9 :i*      
,,fda-approv$ m$ic9es or in=mation      
relat$ to su* m$ic9es2 &  7#b7 imp$es   
access to ,,fda-approv$ m$ic9es or      
in=mation relat$ to su* m$ic9es4  7c7   
,exception ,to def5d aga9/ a claim t a  
limitation or requirem5t violates a     
heal? c>e provid]'s or individual's     
/atutory rights "u subsection 7b71 a    

p>ty mu/ e/abli%1 by cle> & conv9c+     
evid5ce1 t-- 7#a7 ! limitation or       
requirem5t significantly advances access
 to ,,fda-approv$ m$ic9es1 & in=mation  
relat$ to su* m$ic9es2 &  7#b7 access to
 ,,fda-approv$ m$ic9es & in=mation      
relat$ to su* m$ic9es or ! heal? (      
pati5ts _c be advanc$ by a less         
re/rictive alt]native measure or action4
  7d7 ,rule ( con/ruction ,no?+ 9 ?is   
section %all be con/ru$ to limit !      
au?ority ( ! ,secret>y ( ,heal? & ,human
 ,s]vices1 act+ ?r\gh ! ,commission] (  
,food & ,drugs1 to approve a drug "u    
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or  
lic5se a drug "u section #cea ( !       
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb71 or = ! ,f$]al ,gov]nm5t
 to en=ce su* approval or lic5sure4  #e4
 ,applicability & preemption  7a7 ,g5]al
 application  7#a7 ,9 g5]al ,except z   
provid$ 9 subsection 7c71 ?is ,act      
sup]s$es & applies to ! law ( ! ,f$]al  
,gov]nm5t & ea* ,/ate1 & ! implem5tation

 ( su* law1 :e!r /atutory1 common law1  
or o!rwise1 & :e!r adopt$ be=e or aft] !
 date ( enactm5t ( ?is ,act4  7#b7      
,prohibition ,nei!r ! ,f$]al ,gov]nm5t  
nor any ,/ate may adm9i/]1 implem5t1 or 
en=ce any law1 rule1 regulation1 /&>d1  
or o!r provision hav+ ! =ce & effect (  
law 9 a mann] t--  7,a7 prohibits or    
re/ricts ! sale1 provision1 or use ( any
 ,,fda-approv$ m$ic9es 7z def9$ 9       
section #b7b772  7,b7 prohibits or      
re/ricts any individual f aid+ ano!r    
individual 9 volunt>ily obta9+ or us+   
any ,,fda-approv$ m$ic9es2 or  7,c7     
exempts any ,,fda-approv$ m$ic9es f any 
o!r g5]ally applicable law 9 a way t    
w\ld make x m difficult to sell1        
provide1 obta91 or use su* m$ic9es4     
7#c7 ,relation%ip ) o!r laws ,?is ,act  
applies not)/&+ any o!r provision (     
,f$]al law1 includ+ ! ,religi\s ,fre$om 
,re/oration ,act ( #aiic 7#db ,u4,s4,c4 
#bjjj;bb et seq474  7b7  ,subsequ5tly   
enact$ ,f$]al legislation  ,f$]al law   
enact$ aft] ! date ( enactm5t ( ?is ,act

 is subject to ?is ,act1 unless su* law 
explicitly excludes su* application by  
ref]5ce to ?is ,act4  7c7 ,limitations  
,! provisions ( ?is ,act %all n sup]s$e 
or o!rwise affect any provision ( ,f$]al
 law relat+ to cov]age "u 7& %all n be  
con/ru$ z requir+ ! provision ( specific
 b5efits "u7 gr\p heal? plans or gr\p or
 individual heal? insurance cov]age or  
cov]age "u a ,f$]al heal? c>e program 7z
 def9$ 9 section #aabh;,b7f7 ( ! ,social
 ,security ,act 7#db ,u4,s4,c4          
#acbj;a-#g;b7f7771 includ+ cov]age      
provid$ "u section #aije7;a77#d77;,c7 ( 
! ,social ,security ,act 7#db ,u4,s4,c4 
#acif;d7a77#d77;,c77 & section #bgac ( !
 ,public ,heal? ,s]vice ,act 7#db       
,u4,s4,c4 #cjj;gg-#ac74  7d7 ,def5se ,9 
any cause ( action aga9/ an individual  
or entity :o is subject to a limitation 
or requirem5t t violates ?is ,act1 9    
addition to ! rem$ies specifi$ 9 section
 #g1 ?is ,act %all also apply to1 & may 
be rais$ z a def5se by1 su* an          
individual or entity4  7e7 ,effective   

date ,?is ,act %all take effect         
imm$iately ^u ! date ( enactm5t ( ?is   
,act4  #f4 ,rules ( con/ruction  7a7 ,9 
g5]al ,9 int]pret+ ! provisions ( ?is   
,act1 a c\rt %all lib]ally con/rue su*  
provisions to effectuate ! purposes     
describ$ 9 section #c4  7b7 ,rule (     
con/ruction ,no?+ 9 ?is ,act %all be    
con/ru$ to au?orize any gov]nm5t to     
int]f]e ) a heal? c>e provid]'s ability 
to provide ,,fda-approv$ m$ic9es or     
in=mation relat$ to su* m$ic9es or a    
pati5t's ability to obta9 su* m$ic9es4  
7c7 ,o!r individuals consid]$ z gov]nm5t
 (ficials ,any individual :o1 by        
op]ation ( a provision ( ,f$]al or ,/ate
 law1 is p]mitt$ to implem5t or en=ce a 
limitation or requirem5t t violates     
section #d %all be consid]$ a gov]nm5t  
(ficial = purposes ( ?is ,act4  #g4     
,en=cem5t  7a7 ,attorney g5]al ,!       
,attorney ,g5]al may comm5ce a civil    
action on behalf ( ! ,unit$ ,/ates aga9/
 any ,/ate t violates1 or aga9/ any     
gov]nm5t (ficial 7includ+ an individual 

describ$ 9 section #f7;c77 t implem5ts  
or en=ces a limitation or requirem5t t  
violates1 section #d4 ,! c\rt %all hold 
unlawful & set aside ! limitation or    
requirem5t if x is 9 violation ( ?is    
,act4  7b7 ,private "r ( action  7#a7 ,9
 g5]al ,any individual or entity1       
includ+ any heal? c>e provid] or pati5t1
 adv]sely affect$ by an alleg$ violation
 ( ?is ,act1 may comm5ce a civil action 
aga9/ any ,/ate t violates1 or aga9/ any
 gov]nm5t (ficial 7includ+ an individual
 describ$ 9 section #f7;c77 t implem5ts 
or en=ces a limitation or requirem5t t  
violates1 section #d4 ,! c\rt %all hold 
unlawful & set aside ! limitation or    
requirem5t if x is 9 violation ( ?is    
,act4  7#b7 ,heal? c>e provid] ,a heal? 
c>e provid] may comm5ce an action =     
relief on its own behalf1 on behalf ( ! 
provid]'s /aff1 & on behalf ( !         
provid]'s pati5ts :o are or may be      
adv]sely affect$ by an alleg$ violation 
( ?is ,act4  7c7 ,equitable relief ,9   
any action "u ?is section1 ! c\rt may   

aw>d appropriate equitable relief1      
includ+ tempor>y1 prelim9>y1 & p]man5t  
injunctive relief4  7d7 ,co/s ,9 any    
action "u ?is section1 ! c\rt %all aw>d 
co/s ( litigation1 z well z reasonable  
attorney's fees1 to any prevail+        
pla9tiff4 ,a pla9tiff %all n be liable  
to a def5dant = co/s or attorney's fees 
9 any nonfrivol\s action "u ?is section4
  7e7 ,jurisdiction ,! di/rict c\rts ( !
 ,unit$ ,/ates %all h jurisdiction ov]  
proce$+s "u ?is ,act & %all ex]cise !   
same )\t reg>d to :e!r ! p>ty aggriev$  
%all h exhau/$ any adm9i/rative or o!r  
rem$ies t may be provid$ = by law4  7f7 
,abrogation ( /ate immunity ,nei!r a    
,/ate t en=ces or ma9ta9s1 nor a        
gov]nm5t (ficial 7includ+ an individual 
describ$ 9 section #f7;c77 :o is p]mitt$
 to implem5t or en=ce any limitation or 
requirem5t t violates section #d %all be
 immune "u ! ,t5? ,am5dm5t to !         
,con/itution ( ! ,unit$ ,/ates1 !       
,elev5? ,am5dm5t to ! ,con/itution ( !  
,unit$ ,/ates1 or any o!r s\rce ( law1 f

 an action 9 a ,f$]al or ,/ate c\rt (   
compet5t jurisdiction *all5g+ t         
limitation or requirem5t4  #h4          
,sev]ability ,if any provision ( ?is    
,act1 or ! application ( su* provision  
to any individual1 entity1 gov]nm5t1 or 
circum/ance1 is held to be              
uncon/itutional1 ! rema9d] ( ?is ,act1  
or ! application ( su* provision to all 
o!r individuals1 entities1 gov]nm5ts1 or
 circum/ances1 %all n be affect$ !reby4