Legislature(2017 - 2018)GRUENBERG 120

03/29/2017 01:00 PM JUDICIARY

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Heard & Held
-- Public Testimony --
Moved CSHB 108(JUD) Out of Committee
+ Bills Previously Heard/Scheduled TELECONFERENCED
Moved CSHB 123(HSS) Out of Committee
Moved CSHB 42(JUD) Out of Committee
             HB 43-NEW DRUGS FOR THE TERMINALLY ILL                                                                         
1:02:59 PM                                                                                                                    
CHAIR CLAMAN announced that the  first order of business would be                                                               
HOUSE BILL NO.  43, "An Act relating  to prescribing, dispensing,                                                               
and  administering an  investigational drug,  biological product,                                                               
or  device by  physicians for  patients who  are terminally  ill;                                                               
providing  immunity related  to  manufacturing, distributing,  or                                                               
providing   investigational   drugs,  biological   products,   or                                                               
devices;   and  relating   to  licensed   health  care   facility                                                               
1:03:23 PM                                                                                                                    
REPRESENTATIVE JASON GREEN, Alaska State Legislature, read his                                                                  
testimony as follows:                                                                                                           
     So, the goal  of HB 43, or "Right to  Try" is to create                                                                    
     a legal climate in which  a terminally ill patient, who                                                                    
     has exhausted  all FDA approved treatment  options, may                                                                    
     work with their doctor  and drug manufactures to access                                                                    
     investigational treatments that have  passed Phase 1 of                                                                    
     the  FDA  approval  process, but  are  not  yet  widely                                                                    
     available.  The Right to  Try laws have now been passed                                                                    
     in 33  states, 15 additional states,  including Alaska,                                                                    
     are considering the law.                                                                                                   
     Each  year  it  is  estimated  that  over  one  million                                                                    
     Americans die from terminally  ill -- terminal illness.                                                                    
     For those who have  exhausted all FDA approved options,                                                                    
     clinical  trials become  the  next step.   However,  of                                                                    
     those  patients  who attempt  to  gain  entry into  the                                                                    
     clinical trial, it  is found that fewer  than 3 percent                                                                    
     are accepted.                                                                                                              
     In  recognition of  the 97  percent of  patients denied                                                                    
     access to clinical trials, the  FDA does have a program                                                                    
     in  place for  accessing investigational  drugs outside                                                                    
     of  clinical trials  known  as  the "Compassionate  Use                                                                    
     Program."   Nevertheless,  it  is  estimated that  only                                                                    
     about  1,200  people  make   it  through  this  arduous                                                                    
     federal process each year.                                                                                                 
     Given  this  information,  the  goal of  HB  43  is  to                                                                    
     provide  the   same  access   as  the   FDA's  existing                                                                    
     Compassionate Use  Program, but on a  shorter timeline.                                                                    
     By  ensuring --  by  ensuring  terminally ill  patients                                                                    
     have  more  timely  access to  safe,  but  experimental                                                                    
     drugs  in   consultation  with  their  doctor,   HB  43                                                                    
     attempts  to  offer  new hope  when  all  FDA  approved                                                                    
     options have been exhausted.                                                                                               
1:05:31 PM                                                                                                                    
BROOKE IVY, Staff, Representative Jason Grenn, Alaska State                                                                     
Legislature, paraphrased from the sectional analysis as follows                                                                 
[original punctuation provided]:                                                                                                
     Section 1: Prohibits  disciplinary action of physicians                                                                  
     by the State Medical  Board for prescribing, dispensing                                                                    
     or  administering an  investigational drug,  biological                                                                    
     product or  device to terminally ill  patients that are                                                                    
     ineligible  or  unable  to  participate  in  a  current                                                                    
     clinical  trial, have  considered  all other  treatment                                                                    
     options approved  by the FDA and  have provided written                                                                    
     Defines  "investigational  drugs,  biological  products                                                                    
     and devices" as those  that have successfully completed                                                                    
     Phase 1  of the FDA  drug review process and  remain in                                                                    
     ongoing  Phase 2  or 3  clinical trials,  but have  not                                                                    
     been approved for general use.                                                                                             
     Defines  "terminal  illness"  as a  disease  that  will                                                                    
     result in death  in the near future  or permanent state                                                                    
     of unconsciousness from which recovery is unlikely.                                                                        
     Section   2:  Establishes   immunity  for   physicians,                                                                  
     medical  team members,  manufacturers and  distributors                                                                    
     in  the case  of injury  or death  of a  terminally ill                                                                    
     patient  from  the  use  of  an  investigational  drug,                                                                    
     biological   product  or   device,  provided   informed                                                                    
     consent  was obtained  from the  patient and  notice of                                                                    
     immunity was given in advance.                                                                                             
     Establishes immunity  for physicians  and manufacturers                                                                    
     who choose  not to  participate in the  distribution of                                                                    
     an investigational drug, biological product or device.                                                                     
     Section  3:  Amends  statute   limiting  the  sale  and                                                                  
     distribution of new  drugs (AS 17.20.110) so  as not to                                                                    
     apply  to   physicians  prescribing   or  administering                                                                    
     investigational drugs under  the conditions established                                                                    
     in Section 1.                                                                                                              
     Section  4:  Prohibits  the Department  of  Health  and                                                                  
     Social Services  from requiring a licensed  health care                                                                    
     facility   to   increase   its   services   solely   to                                                                    
     accommodate   physicians  prescribing,   dispensing  or                                                                    
     administering investigational drugs to a patient.                                                                          
1:07:42 PM                                                                                                                    
MS. IVY turned to the  PowerPoint presentation titled "House Bill                                                               
43: The  Right to Try,"  slide 3,  "FDA Drug Review  Process" and                                                               
advised  that it  is helpful  to be  familiar with  the different                                                               
phases of the FDA drug review  process.  She explained that prior                                                               
to Phase  1, sponsors of a  drug are required to  submit the form                                                               
"Investigational New  Drug Application"  or IND  application, and                                                               
through this application process  the FDA reviews the applicant's                                                               
pre-clinical testing  results and determines whether  the drug is                                                               
reasonably safe  for human testing.   She then moved to  slide 4,                                                               
"Phase 1 -  Safety" wherein Phase 1 studies  occur after approval                                                               
of  the IND  application.    These studies  may  be conducted  on                                                               
healthy   volunteer   when   testing  Ibuprofen   or   an   anti-                                                               
inflammatory, or  individuals with specific diseases  or terminal                                                               
illnesses.  The goal of Phase  1 testing is to determine possible                                                               
side  effects and  toxicity levels,  wherein Phase  1 focuses  on                                                               
1:08:43 PM                                                                                                                    
MS. IVY turned  to slide 5, "Phase 2- Efficacy"  and advised that                                                               
Phase  2 studies  begin when  a drug  has passed  Phase 1  and is                                                               
considered relatively  safe, with  no unaccepted  toxicity level,                                                               
wherein Phase 2 focuses on  the drug's effectiveness.  She turned                                                               
to slide 6, "Phase 3, and  advised that if there was evidence the                                                               
drug was  effective, it would progress  to Phase 3.   During that                                                               
phase, she explained, more information  would be gained regarding                                                               
safety  and effectiveness,  particularly, in  varying populations                                                               
or different dosages in combination with other medications.                                                                     
1:09:18 PM                                                                                                                    
MS.  IVY  turned   to  slide  7,  "Review  Meeting   &  New  Drug                                                               
Application (NDA"  and advised  that after  Phase 3,  sponsors of                                                               
the drug  participate in a review  meeting with the FDA,  and the                                                               
sponsors go on  to complete a form titled  "New Drug Application"                                                               
(NDA).   In the event the  drug was approved, the  sponsors could                                                               
then market  their drug in the  United States.  From  that point,                                                               
the FDA  has 60  days to  decide whether  to officially  file the                                                               
application  for review  and, she  explained, filed  applications                                                               
are generally processed  within 10 months of filing.   She turned                                                               
to   slide  8,   and   said   that  within   HB   43,  the   term                                                               
"investigational  drug" discusses  those  drugs  that passed  the                                                               
safety testing in Phase 1,  and remain in ongoing clinical trials                                                               
under Phase 2 or 3 of the FDA approval process.                                                                                 
1:09:44 PM                                                                                                                    
MS. IVY  turned to  slide 9, "Compassionate  Use" and  noted that                                                               
the FDA  has an existing  Compassionate Use Program  designed for                                                               
terminally  ill patients  who do  not have  access to  a clinical                                                               
trial.   Within  this program,  patients can  still access  those                                                               
investigational  treatments outside  of the  clinical trial.   In                                                               
order  to start  this process,  a  patient must  work with  their                                                               
doctor and  apply to the FDA.   She commented that  for years, by                                                               
the FDA's own estimate, the  application form alone would take an                                                               
estimated  100  hours  for  the doctor  to  complete.    Although                                                               
recently,  she  pointed  out,  the  FDA  made  great  efforts  to                                                               
streamline  the application  process, but  it is  only the  first                                                               
step  in   the  process.    Manufacturers   must  submit  lengthy                                                               
documentation,  and once  application paperwork  is complete,  it                                                               
must  then  make  its  way  through  the  FDA  internal  approval                                                               
process, and  then to a  separate institutional review  board for                                                               
approval, which is often a lengthy process.                                                                                     
1:10:59 PM                                                                                                                    
MS. IVY  turned to  slide 10,  "The Right to  Try -  A Nationwide                                                               
Effort" and  reiterated that  33 states signed  The Right  to Try                                                               
into law,  and most states  have had overwhelming  bipartisan and                                                               
often unanimous support.                                                                                                        
1:11:22 PM                                                                                                                    
MS.  IVY referred  the  members to  a  document titled  "Clinical                                                               
Trials" included in  the packets, and said that HB  43 focuses on                                                               
terminally ill patients  who do not qualify  for clinical trials.                                                               
The sponsor  included these Alaskan  stories to  illustrate local                                                               
experiences  with terminal  illness, as  well as  the benefit  of                                                               
simply  having access  to  new treatment  options,  whether in  a                                                               
clinical trial or not.                                                                                                          
CHAIR CLAMAN opened public testimony on HB 43.                                                                                  
1:12:40 PM                                                                                                                    
JASON NORRIS,  was unavailable and Representative  Grenn read Mr.                                                               
Norris's letter into the record, as follows:                                                                                    
     I write  to you  today in  support of  HB 43,  with the                                                                    
     short  title "New  Drugs for  the Terminally  Ill."   I                                                                    
     understand that  your time  is limited  and; therefore,                                                                    
     I'll make an effort to be as brief as possible.                                                                            
     In  June of  2011, my  father was  diagnosed with  ALS,                                                                    
     sometimes  known as  Lou Gehrig's  disease.   For those                                                                    
     unfamiliar,  this   disease  slowly  saps   a  person's                                                                    
     ability to move, rendering  them bedridden.  Eventually                                                                    
     it takes away their ability  to breathe, at which point                                                                    
     they die.   It should  be noted that this  disease does                                                                    
     not  affect  a  person's   mind;  therefore,  they  are                                                                    
     acutely  aware   of  their  daily   deterioration,  and                                                                    
     because of this the mind  becomes a prisoner within the                                                                    
     body.    For my  father,  this  began  in June  with  a                                                                    
     reduced  range of  motion in  his  left leg.   At  this                                                                    
     point  he had  been working  12-hour days,  5-6 days  a                                                                    
     week,  per  week  as  a  machinist.   I  feel  this  is                                                                    
     important to  point out because  of the  extended hours                                                                    
     and  physical  nature of  the  job.    He was,  by  all                                                                    
     accounts, a very strong and  healthy man at the time of                                                                    
     diagnosis.   But, by late  fall he had  completely lost                                                                    
     his ability  to walk, and  at Thanksgiving he  held our                                                                    
     5-month old  son for the  last time  in his arms  as he                                                                    
     became too weak to trust  him with such precious cargo.                                                                    
     When  he finally  lost all  movement in  his limbs,  he                                                                    
     would  hug our  children by  nuzzling his  face against                                                                    
     them.  As we entered into  the depths of winter, he and                                                                    
     I  carried on  what conversations  we could,  trying to                                                                    
     accelerate what should have been  more years of passing                                                                    
     knowledge  and  wisdom  from  father  to  son.    These                                                                    
     conversations  became  increasingly  difficult  as  the                                                                    
     disease  made his  breathing quite  labored, even  with                                                                    
     the assistance of  a BiPAP machine.   While the painful                                                                    
     and emotional  moments are too  many to list,  the most                                                                    
     painful came when I asked  him a simple question: "Dad,                                                                    
     are you angry?"   He responded with  uncommon grace and                                                                    
     humility  by  uttering  one  word  with  every  labored                                                                    
     breath, "I'm not  angry, I'm just sad that  I won't see                                                                    
     your  kids grow  up."   And,  in the  early morning  of                                                                    
     February 1, 2012,  he died at the all too  young age of                                                                    
     My  father  was a  good  man  and  my  hero, he  was  a                                                                    
     tireless  worker,  and  a  great  role  model,  and  an                                                                    
     unparalleled family  man.  He  took a chance  on Alaska                                                                    
     in 1996,  when he moved  his family from the  only home                                                                    
     he  had  only   known  to  a  place  that   we  had  no                                                                    
     connections,  no network,  no family,  and no  friends.                                                                    
     The  gamble  paid off  for  all  of  us.   He  saw  the                                                                    
     potential in  this state, he  fought like we all  do to                                                                    
     make a life  here, and in the end I  wish the state had                                                                    
     afforded him the  right to fight this  disease with the                                                                    
     same ferocity.                                                                                                             
     Recently, in  the Washington Post there  was an article                                                                  
     detailing  the experience  of  a man  who  had for  all                                                                    
     intents  and  purposes   beaten  ALS  through  advanced                                                                    
     therapies pioneered  by doctors  at the ALS  Center, in                                                                    
     Atlanta, Georgia.   In reading about this  man I became                                                                    
     aware of the  Right to Try movement.   Soon thereafter,                                                                    
     I became aware  of the bill of which I  write to you in                                                                    
     support of today.  I implore  you to pass this bill and                                                                    
     encourage  your  colleagues in  the  Senate  to do  the                                                                    
     same.    I cannot  say  that  these advanced  therapies                                                                    
     would have helped  save my father's life,  but they may                                                                    
     yet save  someone else's  father, mother,  daughter, or                                                                    
     son.    Thank  you   for  your  consideration  on  this                                                                    
     important legislation.                                                                                                     
1:15:56 PM                                                                                                                    
ELIZABETH  KROME said  she supports  HB 43,  has been  a licensed                                                               
nurse  since 1979,  and practiced  in a  hospital setting  for 30                                                               
years.   Hope is one  thing all  humans require, she  said, after                                                               
being diagnosed with a terminal  condition some patients hope for                                                               
a peaceful  death at home,  for others their  hope is to  live to                                                               
see the  birth of a grandchild,  or a child graduating  from high                                                               
school.   Hope is so  very important to individuals,  she pointed                                                               
out, and the Right to Try allows  a treatment that may or may not                                                               
prolong a life, and allows hope  to continue.  She said she would                                                               
love to  see Alaska  give individuals  the right  to try,  and to                                                               
give them  hope for the next  stage of their life  no matter what                                                               
it might be.                                                                                                                    
1:18:03 PM                                                                                                                    
MICHAEL   MAHARREY,  National   Communications  Director,   Tenth                                                               
Amendment  Center,  said  his  organization  has  supported  this                                                               
legislation across the United States  since its beginning, and he                                                               
called  it "our  no  brainer  issue."   Law  and regulations  are                                                               
supposed to  protect people, but  the regulatory scheme  tends to                                                               
create bureaucracy and  red tape that can cause harm.   Even with                                                               
the FDA's expanded use program, it  does not begin to address the                                                               
black  hole between  the end  of  clinical trials  and the  final                                                               
approval of  treatment.  This process  can take up to  10 months,                                                               
leaving patients in limbo and  between the end of clinical trials                                                               
and the  final approval, patients  do not have  any alternatives.                                                               
He  offered  a  situation  wherein  more  than  70  Texas  cancer                                                               
patients  and a  doctor  began clinical  trials  when the  doctor                                                               
found a successful  treatment for a specific type  of cancer, and                                                               
when the  clinical trials were  close to  the end, the  FDA still                                                               
hadn't given final  approval for the drug.  He  remarked that the                                                               
FDA  basically  told the  doctor  he  had  to stop  treating  his                                                               
patients, except  he was  able to begin  treating them  under the                                                               
Right to Try  new state law in Texas.   Mr. Maharrey related that                                                               
Right to  Try has been so  successful in the State  of Texas that                                                               
the  Texas   legislature  is  considering   a  bill   to  include                                                               
chronically ill  patients.  This type  of legislation illustrates                                                               
the  "beauty of  our  federated structure"  wherein the  American                                                               
system was  never to run based  on a one-size fits  all solutions                                                               
imposed from  Washington, D.C., he  pointed out.   In conclusion,                                                               
he  said, Right  to Try  is a  specific example  of states  using                                                               
their rightful  authority to exercise control  over local issues,                                                               
and if Right  to Try helps even one Alaskan  patient, it is worth                                                               
putting this legislation on the books.                                                                                          
1:20:43 PM                                                                                                                    
KEN LANDFIELD said  he was not aware of any  downside to enacting                                                               
this legislation,  and the  idea of  creating false  hope appears                                                               
disingenuous as terminal is terminal.   This is an easy call and,                                                               
he  pointed out,  within the  Constitution of  the United  States                                                               
there is  a guarantee for the  right to the pursuit  of happiness                                                               
and   it  appears   making  potentially   lifesaving  medications                                                               
available would fall under that category, he said.                                                                              
1:22:18 PM                                                                                                                    
STARLEE  COLEMAN,  Vice  President of  Communications,  Goldwater                                                               
Institute,  advised  that  the Goldwater  Institute  crafted  the                                                               
model  Right to  Try law  upon  which this  bill is  based.   She                                                               
offered that it is important  for Alaskans to understand that the                                                               
organization reached out to doctors  at major research facilities                                                               
across the  country as to why  they don't use the  FDA's existing                                                               
Compassionate  Use  Program.   She  said  that  one of  the  best                                                               
examples  of  why, was  from  a  doctor  who had  previously  run                                                               
clinical trials for  the Indy Anderson Cancer  Center in Houston,                                                               
Texas, and this doctor advised that  she was possibly able to get                                                               
one person  each year  through the FDA's  expanded process.   Ms.                                                               
Colman  said that  if  only one  person a  year,  at the  largest                                                               
cancer  trial center  in  the world,  can get  access  to a  drug                                                               
through the FDA's  process, imagine what it is like  for a person                                                               
in Alaska  who has  seen the community  oncologist who  has never                                                               
run a  clinical trial and  doesn't know who  to call at  the FDA.                                                               
The  chances are  not  good  that this  patient  would be  helped                                                               
through  this program  because the  FDA program  is actually  for                                                               
patients  being treated  at major  research hospitals  performing                                                               
clinical trials  all the time, they  know who to call  and how to                                                               
navigate that system.   She commented that it is  not for regular                                                               
people,  although  it is  known  that  Right  to Try  is  already                                                               
working in Texas, Oregon, and  Florida in accessing new treatment                                                               
options.   These  are real  people  with real  families who  need                                                               
help.   She said she  had received updated information  and Right                                                               
to Try  has now  been adopted in  34 states due  to the  State of                                                               
Kentucky.   She remarked that "no  one who is dying  expects that                                                               
an investigational treatment  will cure them," but  they want the                                                               
right to try  and the choice to take the  same medication used in                                                               
clinical  trials.   The Goldwater  Institute believes  that dying                                                               
people and their families are owed that opportunity, she said.                                                                  
1:25:32 PM                                                                                                                    
CHAIR  CLAMAN,  after  ascertaining  no one  wished  to  testify,                                                               
closed public testimony on HB 43.                                                                                               
1:25:42 PM                                                                                                                    
REPRESENTATIVE  LEDOUX apologized  for coming  in late  and asked                                                               
how a person is able to receive the experimental drugs.                                                                         
MS. IVY  responded that the  FDA has a Compassionate  Use Program                                                               
wherein  a  person can  apply  to  for investigational  drugs  in                                                               
conjunction with their  doctor.  Currently, she  explained, it is                                                               
an application process, and once  the application has been turned                                                               
in, the FDA has  up to 30 days to review  the application and, in                                                               
the event  a question comes up  during the 30 day  period, the 30                                                               
day  clock can  be  reset.   After  that  point,  if the  patient                                                               
receives  approval from  the FDA,  the patient  and their  doctor                                                               
must seek out  an external institutional review  board (IRB), and                                                               
"they have  no requirements" when  they have  to get back  to the                                                               
person  or approve  the application.    In the  event the  review                                                               
board  only meets  every six  months, the  patient would  have to                                                               
wait for the  review and approval of the request.   She said that                                                               
outside of a clinical trial, that  is the only way a person could                                                               
access those investigational drugs.                                                                                             
1:27:12 PM                                                                                                                    
REPRESENTATIVE LEDOUX  noted her  understanding that HB  43 would                                                               
not subject a doctor to  disciplinary action, and asked how would                                                               
a person obtain the drugs and from what manufacturer.                                                                           
MS.  IVY  explained  that  to  be eligible,  a  patient  must  be                                                               
diagnosed  as  terminally ill,  their  doctor  has exhausted  all                                                               
other treatment options for whatever  terminal illness they have,                                                               
and they've attempted  to access a clinical trial.   After all of                                                               
those steps have  been taken, the person or  doctor would contact                                                               
the  manufacturer  and  request  its consent  to  providing  that                                                               
medication,   outside   of   the   clinical   trial,   with   the                                                               
Compassionate Use  Program.   The person,  their doctor,  and the                                                               
manufacturer would all have to  consent to that relationship, she                                                               
1:28:36 PM                                                                                                                    
REPRESENTATIVE LEDOUX asked whether  this type of legislation was                                                               
law in other states, and inquired  as to how cooperative the drug                                                               
companies are to dispensing the  drugs under the circumstances in                                                               
which these types of laws have been enacted.                                                                                    
MS. IVY responded  that similar Right to Try laws  have passed in                                                               
34 states, and  are pending in 14 states, including  Alaska.  She                                                               
acknowledged  that no  action  could  be taken  to  force a  drug                                                               
manufacturer    to   provide    access    to   the    medication.                                                               
Interestingly,  she  offered, due  to  a  new federal  law,  drug                                                               
manufacturers  are required  to list  drug on  their websites  to                                                               
make  the   drug  more  accessible   if  the   drug  manufacturer                                                               
participates  in the  Compassionate Use  Program, and  also lists                                                               
who to  contact.   She said  it is  becoming more  accessible for                                                               
those seeking access  to the Compassionate Use  Program and those                                                               
seeking access outside of that program, she said.                                                                               
1:29:57 PM                                                                                                                    
REPRESENTATIVE LEDOUX  questioned whether any of  these drugs are                                                               
available  in  other  countries,  even  when  they  haven't  been                                                               
approved by the FDA.                                                                                                            
MS. IVY  described Representative  LeDoux's question  as powerful                                                               
because  when discussing  this  legislation  people are  thinking                                                               
about experimental  drugs the nation  had never seen  before, but                                                               
some of  the treatments  going through  the FDA  approval process                                                               
are currently in  use.  For example, in  Europe cancer treatments                                                               
have been in use for  15 years successfully, but those treatments                                                               
still  have to  go  through  the FDA  process,  which could  take                                                               
anywhere from 10  - 15 years to  reach approval.  In  the event a                                                               
treatment  passes   Phase  1  of   the  FDA  process,   per  this                                                               
legislation, a  person would  be able to  work with  their doctor                                                               
and the manufacturer to access that treatment.                                                                                  
REPRESENTATIVE  LEDOUX  referred  to  drugs  available  in  other                                                               
countries   which  are   unavailable  from   the  United   States                                                               
manufacturers,  and asked  what  it would  take  to import  those                                                               
drugs as she assumed this bill doesn't do it.                                                                                   
MS. IVY  replied that she  was unsure  that would be  legal under                                                               
federal  law,  and the  patient  would  have  to travel  to  that                                                               
country to utilize the drug.                                                                                                    
1:32:33 PM                                                                                                                    
EBRAHIM DELPASSAND,  M.D., Excel  Diagnostics &  Nuclear Oncology                                                               
Center,  said his  specialty is  Nuclear  Oncology, and  he is  a                                                               
professor  at the  University of  Texas, Department  of Radiation                                                               
Oncology.  He commented that  Houston, Texas has been using Right                                                               
to Try  to offer  high power  targeted radiation  nuclear therapy                                                               
for a (indisc.) cancer, which are  rare cancers in terms of other                                                               
common  cancers  such as,  breast,  prostrate,  or colon  cancer.                                                               
There is  a special targeted  therapy that was given  to patients                                                               
more than 10 years ago in  Europe, and his patients had to travel                                                               
to Europe  to receive  those treatments.   In  2007, he  found an                                                               
investigation for  new drug  applications with  the FDA  to offer                                                               
these treatments in  Houston.  He said it  took him approximately                                                               
2.5 years to  go through the FDA process and  receive approval to                                                               
start  the investigation  of  trial to  give  patients access  to                                                               
these treatments.  He explained  that he received permission from                                                               
the  drug's owner  to start  these  trials in  the United  States                                                               
because, at that  time, the drug was not ready  to start a trial.                                                               
He said they went through all  of the hoops, and finally made the                                                               
treatments available  to their patients  with the FDA's  "sort of                                                               
approval,"   and  in   2015,  their   Investigational  New   Drug                                                               
Application  (IND) was  active  at his  center  for treatment  of                                                               
these  patients.    Initially,   he  advised,  he  requested  the                                                               
treatment for  60 patients,  then increased  it to  100 patients,                                                               
and  then 150  patients.   In February  2015, as  the center  was                                                               
moving closer to  a 150 patient enrollment,  he requested another                                                               
100  patients  from  the  FDA  because the  drug  was  still  not                                                               
commercially available.   The FDA responded that it  did not want                                                               
him to  increase the  number, not due  to complaints  because his                                                               
patients  had good  responses, the  drug had  a very  good safety                                                               
profile, and  there were many peer  reviewed medical publications                                                               
on this drug from other centers,  but rather because it felt that                                                               
would affect the  commercialization of the drug and  "This is why                                                               
you  have   to  stop."    He   said  he  advised  the   FDA  that                                                               
investigation  of  trial  approval  for  this  drug  had  already                                                               
completed  enrollment, and  actually his  center was  one of  the                                                               
main contributors to that clinical trial  so there was no way his                                                               
continuation of treating  these patients would have  an effect on                                                               
the commercialization  of the  drug.   (Indisc.) to  continue our                                                               
treatment while the FDA had  essentially stop them from providing                                                               
these treatments  to the patients.   He pointed out that  this is                                                               
one of  the scenarios  in which  the Right to  Try laws  can help                                                               
patients receive  their treatments while  the FDA reviews  all of                                                               
the data  to approve the drug  and then later commercialize.   He                                                               
stressed  that this  is the  gap in  which patients  will benefit                                                               
from this  law in receiving  their medication if it  is available                                                               
to them.                                                                                                                        
1:38:25 PM                                                                                                                    
REPRESENTATIVE  KOPP  referred   to  Dr.  Delpassand's  testimony                                                               
regarding the  FDA's decision affecting the  commercialization of                                                               
the  drug,  and asked  whether  he  had  ever witnessed  the  FDA                                                               
colluding with pharmaceutical companies.   Especially in the area                                                               
of  expediting or  delaying  approvals  of investigational  drugs                                                               
through  Phases  1-3  of  clinical  trials  that  Dr.  Delpassand                                                               
believed were harmful to a patient's interest.                                                                                  
DR. DELPASSAND responded  that the nature of  the overall process                                                               
in obtaining approval  has been a lengthy process,  and there are                                                               
several reasons for  that, such as, some  clinical trials require                                                               
follow up  information and the  long term effect on  the patient,                                                               
especially when discussing oncology and  cancer.  He related that                                                               
that is  the nature of clinical  trials because the FDA  wants to                                                               
be sure the drug is safe  and also effective.  He explained there                                                               
are  several reasons  for that  length  of time  because after  a                                                               
review of  considerable data, the  final package is  submitted to                                                               
the FDA, and  thereafter, he said, it sometimes  takes between 12                                                               
and  18 months  until  the FDA  is actually  able  to review  the                                                               
entire  data and  come back  with its  opinion as  to whether  it                                                               
approves or  does not  approve the  drug.  It  is this  period of                                                               
time  wherein  lies  the  problem, especially  if  the  drug  had                                                               
already  shown  effectiveness,  had   many  publications  in  the                                                               
oncology community, or whatever  physicians groups, and this drug                                                               
becomes common  knowledge because then  patients come in  and ask                                                               
for the drug.  The physician,  knowing this drug could help their                                                               
patient, has nothing  to offer because the drug had  not yet been                                                               
approved and  this is  how Right  to Try law  comes into  play in                                                               
certain situations.   He stressed that this law does  not, by any                                                               
means, provide a  shortcut or cutting of corners for  the FDA, or                                                               
any kind  of due diligence  in terms of  making sure the  drug is                                                               
safe and effective.                                                                                                             
1:42:09 PM                                                                                                                    
REPRESENTATIVE FANSLER  asked whether  the exact bill  was passed                                                               
in every state.                                                                                                                 
MS. IVY  answered that  most of the  other versions  included the                                                               
same  FDA criteria,  but there  were different  elements in  each                                                               
1:43:05 PM                                                                                                                    
REPRESENTATIVE  FANSLER referred  to a  letter, in  the committee                                                               
packet  recommending adding  amendments,  and  also changing  the                                                               
definition of terminal  illness, and he asked  Ms. Ivy's response                                                               
to the letter.                                                                                                                  
MS. IVY pointed  to the [3/7/17] letter from  Premera, Blue Cross                                                               
Blue  Shield   of  Alaska,  and   offered  that  the   first  two                                                               
suggestions were  clarifying language in that  a patient's health                                                               
care   insurance   plan   was   not   required   to   cover   the                                                               
investigational drugs or its possible  adverse effects.  She said                                                               
that coverage is  not required under federal or  state statute at                                                               
this time, it  could be included for  clarification purposes, but                                                               
it  is   not  something   the  sponsor   is  requiring   in  this                                                               
legislation.   Also,  she  noted, part  of  the written  informed                                                               
consent  form  required  in  the  bill  involves  a  conversation                                                               
between  a  patient  and  their  doctor  regarding  the  lack  of                                                               
coverage for the  investigational drug, which is  FDA guidance on                                                               
those informed  consent forms.   The third recommendation  had to                                                               
do with "what they may not  deny coverage for," and the sponsor's                                                               
reading was  that it may  add additional protections to  the bill                                                               
for the patient in that, "a  health insurer may not deny coverage                                                               
to a  patient for pre-existing conditions,  benefits that accrued                                                               
before  the  day  in  which  the patient  was  treated  with  the                                                               
unapproved investigational drug or  palliative care for a patient                                                               
previously  treated   who  is  no  longer   currently  using  the                                                               
investigational drug."  She opined  that a "majority of this" was                                                               
already mandated  in the Affordable  Care Act; however,  it could                                                               
be something the committee could  consider including if it wanted                                                               
to  look down  the  road  whether there  may  be  changes at  the                                                               
federal level.  She advised  that the sponsor's office spoke with                                                               
Legislative Legal  and Research Services regarding  this language                                                               
and it  didn't indicate there  were particular risks  involved in                                                               
including  the language.   Finally,  she advised,  the definition                                                               
Premera,  Blue  Cross  Blue  Shield  of  Alaska  suggested  would                                                               
streamline it with Medicare's definition  of terminal illness and                                                               
limit it to  those who may die  within the next six  months.  She                                                               
explained that the  sponsor believes the definition  is narrow in                                                               
that if a terminally ill patient  was given seven months to live,                                                               
they would not be eligible to  participate under the Right to Try                                                               
laws.   The sponsor  could not see  this narrow  definition, even                                                               
though   the  Compassionate   Use  Program,   and  he   does  not                                                               
necessarily support that amendment.                                                                                             
1:46:33 PM                                                                                                                    
REPRESENTATIVE FANSLER  thanked Ms.  Ivy for  the map  because it                                                               
depicted  the almost  universal acceptance  of this  program, and                                                               
noticed that  Hawaii vetoed  the legislation.   He  asked whether                                                               
she had any information as to the veto.                                                                                         
MS.  IVY  answered  that previously,  California  Governor  Jerry                                                               
Brown had vetoed the Right to  Try law, and later the legislation                                                               
was brought  forward again  and Governor  Brown changed  his mind                                                               
based on its  success stories.  As far as  Hawaii, Governor David                                                               
Ige, in his veto statement listed  four reasons, as follows:  the                                                               
Compassionate Use  Program already  existed and  provided access;                                                               
this could interfere  with the overall FDA system  which may have                                                               
unintended  consequences in  delaying development  of potentially                                                               
lifesaving  drugs, of  which the  bill sponsor  would argue  that                                                               
this doesn't  impact the  Phases 1-3  clinical trial  process; it                                                               
violated  the Supremacy  Clause; and,  he was  unclear as  to the                                                               
actual benefits to the patient.                                                                                                 
MS.  IVY,  in  response  to  Representative  Fansler,  agreed  to                                                               
provide the committee with Dr. Delpassand's written testimony.                                                                  
1:49:50 PM                                                                                                                    
MS. IVY,  in responded to Representative  Reinbold, answered that                                                               
this   bill  is   limited  solely   to  the   Right  to   Try  in                                                               
REPRESENTATIVE REINBOLD commented that  she was in pharmaceutical                                                               
sales  for  almost  10  years  in  Alaska,  and  in  response  to                                                               
Representative LeDoux's  previous question, answered  that within                                                               
the company  she worked  for, it took  approximately 17  years to                                                               
move  from inception  to the  FDA's final  approval.   In getting                                                               
Alaskans on clinical trials, the  company had to compete with big                                                               
states  because  it  is  easier   to  have  many  patients  in  a                                                               
concentrated  effort.    She  encouraged  continued  vetting  and                                                               
related that  the comment  about giving  "false hope"  was valid.                                                               
Recently,  she said,  a friend  was put  on a  clinical trial  in                                                               
California, was given great hope  that this would be a successful                                                               
drug for her,  and it ended up  that there was no  result at all.                                                               
She said  she appreciates the  bill coming forward and  that this                                                               
is an opportunity for Alaska to participate.                                                                                    
1:52:54 PM                                                                                                                    
REPRESENTATIVE EASTMAN  commented that  with the success  of this                                                               
legislation  in  34  states,  and states  trying  to  expand  the                                                               
program to  the chronically ill, asked  the sponsor's perspective                                                               
on an amendment  that may expand it to the  chronically ill based                                                               
upon its success.                                                                                                               
MS.  IVY  responded  that  Texas  is the  one  state  looking  at                                                               
potentially  expanding  the  definition of  terminal  illness  to                                                               
debilitating diseases due to the  law's successes.  The Goldwater                                                               
Institute   offered  concerning   regarding   that  concept   and                                                               
preferred  the  initial  narrow definition  move  forward  before                                                               
looking to  expand because  it was a  new process  throughout the                                                               
different  states.     Additionally,  she  said,   there  is  the                                                               
potential for a  court challenge, and the bill  sponsor is trying                                                               
to  target  the existing  access  through  the Compassionate  Use                                                               
Program and  streamline that timing.   Expanding  the definition,                                                               
she  pointed out,  could  potentially get  into  questions as  to                                                               
whether  the legislation  was taking  on the  FDA's process  on a                                                               
larger  scope,  and how  far  to  expand  that definition.    She                                                               
offered that  it is a policy  call, and at this  time the sponsor                                                               
would  prefer  to  stay  within the  more  narrow  definition  of                                                               
terminal illness.                                                                                                               
1:54:56 PM                                                                                                                    
REPRESENTATIVE EASTMAN  acknowledged there are  several parallels                                                               
with this  bill and a  separate bill  making its way  through the                                                               
legislature in dealing  with assisted suicide.  Due  to the bills                                                               
being similar,  he asked the  sponsor's thoughts as  to inserting                                                               
language into the  bill to make clear that is  definitely not the                                                               
direction of this bill.                                                                                                         
MS.  IVY advised  that it  is the  sponsor's position  that these                                                               
bills are different as to intent  because the issues are Right to                                                               
Die  and  Right   to  Try;  however,  the  sponsor   is  open  to                                                               
discussions regarding adding clarifying language.                                                                               
1:55:52 PM                                                                                                                    
REPRESENTATIVE  LEDOUX noted  that  she was  late attending  this                                                               
hearing,  that  some  of  her questions  may  have  already  been                                                               
answered, and asked  the committee's indulgence.   She then asked                                                               
whether  there   had  been  any  organized   opposition  to  this                                                               
legislation, or  organized opposition  to similar bills  in other                                                               
MS. IVY answered, not to  her knowledge in Alaska, but nationally                                                               
there  had  been   concern  over  creating  false   hope.    Some                                                               
individuals, in response to that  concern have said, "It's better                                                               
to  have some  hope than  no hope  at all."   The  Alaska Medical                                                               
Board and  the Commission  on Aging  offered letters  of support,                                                               
and  as to  the national  support, she  said she  would defer  to                                                               
Starlee Coleman at the Goldwater Institute.                                                                                     
1:56:47 PM                                                                                                                    
REPRESENTATIVE  LEDOUX  noted  that  either  Aetna  Insurance  or                                                               
Premera  Blue  Cross  Blue  Shield of  Alaska  had  suggested  an                                                               
amendment, and asked the sponsor's view of that amendment.                                                                      
MS.  IVY pointed  to the  3/7/17 letter  from Premera  Blue Cross                                                               
Blue Shield of Alaska that  Representative Fansler had previously                                                               
inquired  about,  and  explained  that the  first  two  suggested                                                               
amendments  may   be  unnecessary  as  they   are  not  currently                                                               
requiring insurers  to cover investigational drugs  under federal                                                               
or  state statute.   The  third suggestion  could add  additional                                                               
protections  if  that   was  the  will  of   the  committee,  but                                                               
currently,  some of  these are  mandated by  the Affordable  Care                                                               
Act.   She advised that  in terms of  narrowing the scope  of the                                                               
definition  of terminal  illness,  the sponsor  does not  support                                                               
that suggestion.                                                                                                                
[HB 43 was held over.]                                                                                                          

Document Name Date/Time Subjects
HB043 ver D 3.14.17.PDF HJUD 3/29/2017 1:00:00 PM
HJUD 4/3/2017 1:00:00 PM
HB 43
HB043 Sponsor Statement 3.14.17.pdf HJUD 3/29/2017 1:00:00 PM
HB 43
HB043 Sectional Analysis ver D 3.14.17.pdf HJUD 3/29/2017 1:00:00 PM
HJUD 4/3/2017 1:00:00 PM
HB 43
HB043 Supporting Document-Legislative Map 3.14.17.pdf HJUD 3/29/2017 1:00:00 PM
HB 43
HB043 Supporting Document-FDA Drug Review Process 3.14.17.pdf HJUD 3/29/2017 1:00:00 PM
HB 43
HB043 Supporting Document-Goldwater Institute Fact Sheet 3.14.17.pdf HJUD 3/29/2017 1:00:00 PM
HB 43
HB043 Supporting Document-Goldwater Institute Patient Stories 3.14.17.pdf HJUD 3/29/2017 1:00:00 PM
HB 43
HB043 Supporting Document-Clinical Trials in Alaska 3.14.17.pdf HJUD 3/29/2017 1:00:00 PM
HB 43
HB043 Supporting Document-Letters and Emails of Support 3.14.17.pdf HJUD 3/29/2017 1:00:00 PM
HB 43
HB043 Additional Document-Letter from Premera 3.27.17.pdf HJUD 3/29/2017 1:00:00 PM
HB 43
HB43 Additional Document-Powerpoint Presentation 3.27.17.pdf HJUD 3/29/2017 1:00:00 PM
HB 43
HB043 Powerpoint Presentation with Video.pptx HJUD 3/29/2017 1:00:00 PM
HB 43
HB043 Fiscal Note DCCED-CBPL 3.14.17.pdf HJUD 3/29/2017 1:00:00 PM
HB 43
HB042 Amendment #8 3.28.17.pdf HJUD 3/29/2017 1:00:00 PM
HB 42
HB042 Amendments #1-8 3.28.17.pdf HJUD 3/29/2017 1:00:00 PM
HB 42
HB042 Amendments #1-8 - HJUD Final Votes 3.29.17.pdf HJUD 3/29/2017 1:00:00 PM
HB 42
HB123 Amendments #1-4 3.28.17.pdf HJUD 3/29/2017 1:00:00 PM
HB 123
HB123 Amendments #1-4 - HJUD Final Votes 3.29.17.pdf HJUD 3/29/2017 1:00:00 PM
HB 123