Legislature(2017 - 2018)BUTROVICH 205

01/24/2018 01:30 PM HEALTH & SOCIAL SERVICES

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01:30:05 PM Start
01:31:09 PM HB43
02:26:53 PM Adjourn
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
Heard & Held
-- Public Testimony --
            HB  43-NEW DRUGS FOR THE TERMINALLY ILL                                                                         
1:31:09 PM                                                                                                                    
CHAIR  WILSON  announced the  consideration  of  HB 43  with  his                                                               
intent  to hear  and hold  the bill.  [CSHB 43(JUD),  version 30-                                                               
LS0207\J, was before the committee.]                                                                                            
1:31:31 PM                                                                                                                    
REPRESENTATIVE JASON GRENN, Alaska  State Legislature, sponsor of                                                               
HB 43, paraphrased the first paragraph of his sponsor statement:                                                                
     House Bill 43 would allow terminally ill patients who                                                                      
     have exhausted other available treatments and do not                                                                       
     qualify for clinical trials to gain faster access to                                                                       
     safe, but experimental drugs in an effort to save                                                                          
     their own lives. By providing certain immunities to                                                                        
     prescribing physicians, manufacturers and distributors                                                                     
     acting in good faith, this bill would allow terminal                                                                       
     patients, in consultation with their doctor, the                                                                           
     freedom to try new treatments as they fight to                                                                             
     survive, without the burden of waiting for federal                                                                         
REPRESENTATIVE  GRENN  noted  that  since 2014,  38  states  have                                                               
signed  similar  legislation  into  law  with  strong  bipartisan                                                               
support. HB  43 is supported  by the Alaska State  Medical Board,                                                               
the  Alaska  Commission  on   Aging,  individual  providers,  and                                                               
countless Alaskans. Last session the bill passed the House 40-0.                                                                
He  said  more than  1  million  Americans  die from  a  terminal                                                               
illness every year. Fewer than  three percent of patients who try                                                               
to be  become part of a  clinical trial are accepted.  The United                                                               
States  Food and  Drug Administration  (FDA) has  a compassionate                                                               
care  process to  allow patients  to  access experimental  drugs.                                                               
Nationally, estimates are that only  1,200 people make it through                                                               
this  federal process.  HB 43  provides the  same access  the FDA                                                               
program gives, but on a shorter timeline.                                                                                       
He said HB  43 is similar to the FDA  compassionate care program,                                                               
but on  a shorter  timeline. "HB  43 attempts  to offer  new hope                                                               
when  all other  FDA-approved  options have  been exhausted,"  he                                                               
1:34:15 PM                                                                                                                    
REPRESENTATIVE GRENN  read from  a letter of  support from  a man                                                               
whose father  died of ALS,  often known as Lou  Gehrig's disease,                                                               
at the age  of 58. The man  wished his father had  had options to                                                               
try other treatments.                                                                                                           
1:35:33 PM                                                                                                                    
BROOKE   IVY,   Staff,   Representative   Grenn,   Alaska   State                                                               
Legislature,  provided  an overview  of  HB  43 paraphrasing  the                                                               
following sectional analysis:                                                                                                   
     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  or the marketing                                                                    
     application  process, 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.                                                                          
1:37:55 PM                                                                                                                    
MS. IVY  reviewed the FDA's  Drug Review Process. Prior  to Phase                                                               
One, sponsors of a drug  submit an Investigational New Drug (IND)                                                               
1:38:32 PM                                                                                                                    
MS. IVY said the FDA  then reviews preclinical testing results to                                                               
determine  whether the  drug is  reasonably safe  for testing  in                                                               
humans. Phase  One studies  occur after the  approval of  the IND                                                               
application.  The  goal of  Phase  One  testing is  to  determine                                                               
possible side effects and toxicity levels.                                                                                      
1:39:09 PM                                                                                                                    
MS. IVY said drugs that  pass Phase One are considered relatively                                                               
safe and Phase Two focuses on a drug's effectiveness.                                                                           
1:39:26 PM                                                                                                                    
MS.  IVY  said drugs  considered  effective  pass onto  to  Phase                                                               
Three,   where  more   information  is   gained  on   safety  and                                                               
effectiveness,  particularly  with  varying  populations  and  in                                                               
combination with other drugs.                                                                                                   
1:39:38 PM                                                                                                                    
MS. IVY said that after Phase  Three, sponsors have a drug review                                                               
meeting with the  FDA and complete a New  Drug Application (NDA).                                                               
If approved the drug can be marketed in the United States.                                                                      
1:40:00 PM                                                                                                                    
SENATOR  VON IMHOF  asked  how long  each phase  is  and how  the                                                               
clinical trials fit into the four phases.                                                                                       
1:40:38 PM                                                                                                                    
MS. IVY said although she did  not have specifics for each phase,                                                               
the average time is 10 to  15 years for the FDA approval process.                                                               
Clinical trials are part of Phases  One, Two, and Three. HB 43 is                                                               
about drugs that have completed  Phase One clinical trials, which                                                               
tests toxicity, so drugs are in Phases Two and Three.                                                                           
1:41:46 PM                                                                                                                    
MS. IVY said with the  FDA's compassionate care program, designed                                                               
for terminally  ill patients without  access to  clinical trials,                                                               
patients must first work with their  doctors to apply to the FDA.                                                               
By the FDA's own estimate,  the application took 100 doctor hours                                                               
to  complete. Recently  the FDA  has been  trying to  reduce that                                                               
time, but the application is only  the first step in the process.                                                               
Manufacturers must  also submit  lengthy documentation.  After an                                                               
application has  made its way  through the FDA  internal process,                                                               
an individual  must seek  out an  institutional review  board for                                                               
1:42:53 PM                                                                                                                    
SENATOR BEGICH  asked if any of  the laws passed in  the other 38                                                               
states impede the clinical trial process.                                                                                       
1:43:42 PM                                                                                                                    
MS. IVY said  that has been a concern in  other states with Right                                                               
to  Try and  the bill  includes  language that  patients must  be                                                               
unable to participate in clinical trials.                                                                                       
1:44:52 PM                                                                                                                    
SENATOR  BEGICH asked  if the  bill  applies only  to people  who                                                               
could not participate in clinical trials.                                                                                       
1:45:08 PM                                                                                                                    
MS. IVY said  yes, and the goal is that  clinical trials continue                                                               
to benefit from the process in place.                                                                                           
1:45:24 PM                                                                                                                    
SENATOR VON  IMHOF asked what kind  of data is collected  in what                                                               
she would  call a subset of  clinical trials and how  is it used,                                                               
if collected.                                                                                                                   
1:46:12 PM                                                                                                                    
MS.  IVY  explained that  data,  whether  inside or  outside  the                                                               
clinical trials, is always important  to manufacturers. They must                                                               
report  that  data to  the  FDA.  That  data is  collected  under                                                               
existing federal law                                                                                                            
SENATOR  VON  IMHOF said  that  although  there are  no  controls                                                               
outside of clinical trials, data is always important.                                                                           
MS. IVY  said 38  states have  Right to  Try legislation,  and 11                                                               
states have legislation pending, including Alaska.                                                                              
SENATOR GIESSEL asked why Hawaii vetoed its Right to Try bill.                                                                  
1:48:07 PM                                                                                                                    
MS. IVY  said Governor  [Jerry] Brown  in California  vetoed this                                                               
legislation  in 2015,  but later  reversed his  veto. But  Hawaii                                                               
Governor [David] Ige  noted his veto before he  later changed it.                                                               
Governor Ige  listed four  reasons for vetoing  the bill:  1. The                                                               
FDA  compassionate care  process already  provided access.  2. It                                                               
intervened  with  FDA  system,  which may  have  the  inadvertent                                                               
consequence of delaying  new drugs. 3. It  violated the supremacy                                                               
clause. 4. He was unsure of patient benefits.                                                                                   
SENATOR VON IMHOF  asked when the legislation  was introduced and                                                               
vetoed  in Hawaii  and  if there  have  been further  discussions                                                               
about that legislation.                                                                                                         
MS. IVY  said it  was vetoed  in May 2016,  and she  would report                                                               
later on the current status of the legislation in Hawaii.                                                                       
MS. IVY drew attention to  Clinical Trials: A student's interview                                                               
of  nurses, patients  and survivors  experience  and opinions  of                                                               
cancer  and  clinical  trials in  Alaska  document  in  committee                                                               
members'  packets. She  said these  stories helped  to illustrate                                                               
the benefit of having access to new treatments.                                                                                 
1:51:18 PM                                                                                                                    
CHAIR WILSON  pointed out that  Claire Radford,  from Legislative                                                               
Legal Services and Deb Stovern,  the executive administrator, the                                                               
Alaska State Medical Board, were available to answer questions.                                                                 
He asked how many Alaskans would benefit from the law.                                                                          
MS. IVY replied that it is  difficult to say, but for individuals                                                               
who would benefit, the impact  would be enormous because it could                                                               
be  the difference  between  life  and death.  Even  if only  one                                                               
person benefits, it would be worth it.                                                                                          
CHAIR WILSON asked if there was  a time restriction for a patient                                                               
to be on a  trial drug. If the FDA approval for a  new drug is 10                                                               
to 15  years, could someone  stay on a  trial drug until  the FDA                                                               
denied or approved the drug?                                                                                                    
MS. IVY  said every  clinical trial  is designed  differently and                                                               
has  different  lengths  and qualifications,  so  she  could  not                                                               
specifically address the question of time.                                                                                      
1:53:38 PM                                                                                                                    
SENATOR GIESSEL noted  that in a February 2017  letter the Alaska                                                               
State  Medical Board  took a  neutral position  because a  no use                                                               
clause is  not included in  the bill. Her interpretation  is that                                                               
refers to a  removal of the liability for a  person who chooses a                                                               
clinician who  chooses not to  prescribe this. She did  think the                                                               
bill addressed it on  page 3, lines 10 and 11,  but asked Ms. Ivy                                                               
to respond.                                                                                                                     
MS.  IVY said  that statement  about no  use referenced  a Senate                                                               
bill. HB 43 does include  language that would protect physicians,                                                               
manufacturers,  and other  stakeholders who  would choose  not to                                                               
participate for a variety of reasons.                                                                                           
1:55:12 PM                                                                                                                    
SENATOR GIESSEL  asked if the no  use issue was addressed  in the                                                               
bill on line on page 3, lines  10 and 11, which reads, "a person,                                                               
acting in good  faith and with reasonable care, is  not liable in                                                               
an action  for damages solely  for declining  to prescribe .  . .                                                               
and provide."                                                                                                                   
MS. IVY said that is correct.                                                                                                   
SENATOR  GIESSEL asked  MS  Stovern if  the  State Medical  Board                                                               
still stands  by its neutral position  on HB 43 as  stated in its                                                               
February 2107 letter.                                                                                                           
1:55:57 PM                                                                                                                    
DEBORA  STOVERN, Executive  Administrator,  Alaska State  Medical                                                               
Board,  answered  questions  about  HB  43.  She  apologized  for                                                               
confusion in  the letter,  which was  written for  both SB  19, a                                                               
similar bill, and HB 43. The  neutral position was for SB 19. The                                                               
board does support HB 43.                                                                                                       
1:56:53 PM                                                                                                                    
SENATOR BEGICH  asked if  a drug  being used  under Right  to Try                                                               
would  still be  used  if  it was  ruled  unsafe during  clinical                                                               
MS.  IVY  said  its  use   would  be  stopped.  HB  43  clarifies                                                               
investigational drugs must remain in ongoing clinical trials.                                                                   
SENATOR  BEGICH   stated  that   clarification  makes   him  more                                                               
comfortable about the bill.                                                                                                     
SENATOR GIESSEL  called attention to  the March 2017  letter from                                                               
Premera. Premera  suggested that  a new section  be added  to the                                                               
bill. Item B  of this proposed section states  that the patient's                                                               
"insurance plan  is not required  to pay, and may  deny coverage"                                                               
if  there's  been  demonstrated  to be  associated  any  harm  or                                                               
adverse  effect.  She  asked  Ms.  Ivy what  language  in  HB  43                                                               
addressed this issue.                                                                                                           
She then  identified the language  as being  on page 2,  line 10.                                                               
She brought up the suggested  language in the Premera letter that                                                               
said that a health care insurer  may, but is not required to, pay                                                               
for coverage  for the investigative  drug. She thought HB  43 did                                                               
not address insurance.                                                                                                          
2:00:05 PM                                                                                                                    
MS.  IVY responded  that insurance  coverage being  referenced in                                                               
the  letter  is  not  required   by  state  or  federal  statute.                                                               
Clarifying  language  could  be  added, but  the  sponsor  didn't                                                               
include it since it is not required by state or federal law.                                                                    
MS. IVY  said the informed  consent part  of the bill  involves a                                                               
discussion between  a patient  and doctor  regarding the  lack of                                                               
insurance for an investigational drug.                                                                                          
SENATOR  GIESSEL  said  often  pharmaceutical  companies  do  not                                                               
charge  for experimental  medications. She  asked how  often that                                                               
happens with these types of experimental medications.                                                                           
MS.  IVY said  federal  law  does allow  for  cost recovery,  but                                                               
manufacturers  cannot sell  experimental  drugs  for profit.  She                                                               
said she would need to do  further research to find out how often                                                               
they are given away for no charge.                                                                                              
SENATOR GIESSEL  asked whether it was  true that if a  patient is                                                               
accepted into a clinical trial, the  patient does not pay for the                                                               
MS. IVY  said she believed  that is usually true,  although there                                                               
are other costs a patient might have to pay for.                                                                                
2:03:23 PM                                                                                                                    
SENATOR GIESSEL noted  that part of the  Premera letter suggested                                                               
a definition  of a  terminal illness  that stated,  "a reasonable                                                               
likelihood that death will occur within  six months." HB 43 has a                                                               
different definition on  page two, lines 14-16. She  asked why HB
43 did not have Premera's language.                                                                                             
MS.  IVY said  the  House discussed  the  definition of  terminal                                                               
illness. The definition in the bill  is one used by other states.                                                               
Premera offered  Medicare's definition  of 6 months.  The sponsor                                                               
thought  that timeframe  was too  narrow.  The compassionate  use                                                               
program does not have a definition for terminal illness.                                                                        
SENATOR GIESSEL said the bill's  definition of a terminal illness                                                               
on page  2, line 15,  says "death in  the near future,"  which is                                                               
nebulous. She asked what is "the near future."                                                                                  
2:06:10 PM                                                                                                                    
CLAIRE RADFORD,  Staff, Legislative Legal Services,  Alaska State                                                               
Legislature, answered questions  about HB 43. She  said the state                                                               
medical board would define any definitions that are not clear.                                                                  
SENATOR GIESSEL said  Ms. Radford was pointing out  that under AS                                                               
08.64, the medical board would have authority to do this.                                                                       
2:07:08 PM                                                                                                                    
SENATOR VON IMHOF said she  was concerned about Premera's request                                                               
to add a section 5 to  the bill of clarifying language for health                                                               
insurance. She  wondered whether  it wasn't the  health insurance                                                               
policy  that  should state  what  coverage  is. Health  insurance                                                               
policies are updated on a regular  basis, but that is not usually                                                               
true for  statutes. She asked  Ms. Ivy if she  asked Premera/Blue                                                               
Cross and  Blue Shield  of Alaska  how they  handle the  issue in                                                               
their policies and what they cover for clinical trials.                                                                         
MS. IVY  said in  conversations with  Premera/Blue Cross  she did                                                               
not ask  for copies  of policies and  how they  handled coverage.                                                               
The  sponsor  may agree  that  referencing  a  point in  time  in                                                               
statute can be problematic. The  elements of pointing out what is                                                               
not  covered  is  not  currently required  by  state  or  federal                                                               
statute. The  suggested Section  5c in  the Premera  letter about                                                               
what would  be covered  is mandated  in the  [federal] Affordable                                                               
Care Act (ACA).  If the ACA changes then the  state statute would                                                               
have  to  be  changed.  The bill's  current  language  would  not                                                               
require any changes in current  statutes. She offered to research                                                               
how insurance policies currently address the issue.                                                                             
2:10:24 PM                                                                                                                    
SENATOR BEGICH  asked when  the 38 states  passed their  laws and                                                               
how are they working.                                                                                                           
MS. IVY  said the  Right to Try  legislation movement  started in                                                               
2014. Florida,  Oregon, and Texas  have some success  stories. In                                                               
Texas, a  doctor used a  promising treatment available  in Europe                                                               
with 150  patients, but the FDA  would not allow him  to continue                                                               
to  treat his  patients when  the trials  were completed.  He was                                                               
able to resume treatment after Texas  passed its Right to Try law                                                               
and many  patients, who were given  three to six months  to live,                                                               
are still alive a year later.                                                                                                   
2:12:31 PM                                                                                                                    
SENATOR BEGICH relayed a story  of a close friend with pancreatic                                                               
cancer who was given 6 months to  live. He left the country for a                                                               
clinical trial. He lived long enough  for his daughter, who was 4                                                               
years old at the time of  his diagnosis, to have memories of him.                                                               
It almost  bankrupted his friend's  family. He said  the proposal                                                               
is overdue because the opportunity to extend life is important.                                                                 
SENATOR GIESSEL asked whether the  states that did not have Right                                                               
to Try laws have offered legislation.                                                                                           
MS. IVY said yes, all have Right to Try legislation introduced.                                                                 
2:14:37 PM                                                                                                                    
CHAIR WILSON opened public testimony                                                                                            
2:14:55 PM                                                                                                                    
STARLEE  COLEMAN,  Senior  Policy Advisor,  Goldwater  Institute,                                                               
provided  information on  Right to  Try  laws. She  said the  FDA                                                               
compassionate care program, particularly  for patients in Alaska,                                                               
is not  a practical  option. About  1,200 people  a year  make it                                                               
through  the  FDA's  compassionate  care  process.  About  25,000                                                               
people  a year  are in  a similar  program in  France. France,  a                                                               
country with  a population one-fifth  size of the  United States,                                                               
helps 2,000 percent more people.  America has a red tape problem.                                                               
The   Institute  receives   two  responses   from  doctors   when                                                               
discussing the  compassionate care program: the  what program and                                                               
oh, that is impossible.                                                                                                         
2:16:43 PM                                                                                                                    
MS. COLEMAN  said according to a  doctor who ran the  early stage                                                               
clinical  trials center,  the largest  in  the world,  at the  MD                                                               
Anderson Cancer  Center in Houston,  the center was only  able to                                                               
get one  person a year  into the FDA compassionate  care program.                                                               
Imagine  the obstacles  in  Alaska.  Practical opportunities  for                                                               
people who are not in big  hospitals in big cities to have access                                                               
to clinical trials are not good.  Right to Try legislation is one                                                               
of  the  only  options  for   people  in  these  situations.  The                                                               
institute has  talked to hundreds  of families and has  heard the                                                               
same  thing.  No one  expects  a  guarantee,  but they  want  the                                                               
opportunity  to try.  "We  feel  we owe  dying  people and  their                                                               
families that opportunity," she said.                                                                                           
2:20:44 PM                                                                                                                    
MS. COLEMAN  said the  question has come  up about  whether these                                                               
laws  conflict with  federal law.  States have  the authority  to                                                               
provide  additional  constitutional   rights  above  the  federal                                                               
floor.  States   can  go   above  what   is  guaranteed   in  the                                                               
Constitution. There have been no efforts  by the FDA to shut down                                                               
these laws or intervene in treatment.                                                                                           
MS. COLEMAN said  the U.S. Senate last  summer unanimously passed                                                               
a law to  protect states that have passed Right  to Try laws from                                                               
federal interference.  They are hoping  the U.S. House  will pass                                                               
the law soon and Alaska will  know it will have the federal stamp                                                               
of approval for this law.                                                                                                       
2:24:09 PM                                                                                                                    
SENATOR  BEGICH  asked  if  she   said  the  federal  law  passed                                                               
unanimously in the U.S. Senate.                                                                                                 
MS. Coleman said that is correct.                                                                                               
2:24:35 PM                                                                                                                    
CHAIR WILSON opened public testimony.                                                                                           
2:25:02 PM                                                                                                                    
KEN LANDFIELD, Representing Self, testified  in support of HB 43.                                                               
He  said he  could not  imagine any  reason not  to support  this                                                               
2:26:10 PM                                                                                                                    
CHAIR WILSON closed public testimony.                                                                                           
2:26:24 PM                                                                                                                    
CHAIR WILSON held HB 43 in committee.                                                                                           

Document Name Date/Time Subjects
HB43 ver J.PDF SHSS 1/24/2018 1:30:00 PM
HB 43
HB43 Sponsor Statement.pdf SHSS 1/24/2018 1:30:00 PM
HB 43
HB43 Sectional Analysis ver J.pdf SHSS 1/24/2018 1:30:00 PM
HB 43
HB43 Fiscal Note DCCED-CBPL-01-19-18.pdf SHSS 1/24/2018 1:30:00 PM
HB 43
HB43 Explanation of Changes D to J.pdf SHSS 1/24/2018 1:30:00 PM
HB 43
HB43 Additional Document - Letter from Premera.pdf SHSS 1/24/2018 1:30:00 PM
HB 43
HB43 Supporting Document - Clinical Trials in Alaska.pdf SHSS 1/24/2018 1:30:00 PM
HB 43
HB43 Supporting Document - FDA Drug Review Process.pdf SHSS 1/24/2018 1:30:00 PM
HB 43
HB43 Supporting Document - Goldwater Institute Fact Sheet.pdf SHSS 1/24/2018 1:30:00 PM
HB 43
HB43 Supporting Document - Goldwater Institute Patient Stories.pdf SHSS 1/24/2018 1:30:00 PM
HB 43
HB43 Supporting Document - Legislative Map.pdf SHSS 1/24/2018 1:30:00 PM
HB 43
HB43 Supporting Document - Letters of Support 4.11.17.pdf SHSS 1/24/2018 1:30:00 PM
HB 43
HB43 Powerpoint Presentation 1.20.2018.pdf SHSS 1/24/2018 1:30:00 PM
HB 43