Legislature(2015 - 2016)BELTZ 105 (TSBldg)

04/11/2016 01:30 PM JUDICIARY

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* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
-- Public Testimony --
+= SB 108 AK SECURITIES ACT; PENALTIES; CRT. RULES TELECONFERENCED
Moved CSSB 108(L&C) Out of Committee
+ SB 113 NEW DRUGS FOR THE TERMINALLY ILL TELECONFERENCED
Moved CSSB 113(HSS) Out of Committee
*+ SB 211 RECOVERY OF FALSE CLAIMS FOR STATE FUNDS TELECONFERENCED
Scheduled but Not Heard
+ Bills Previously Heard/Scheduled TELECONFERENCED
**Streamed live on AKL.tv**
            SB 113-NEW DRUGS FOR THE TERMINALLY ILL                                                                         
                                                                                                                                
1:50:02 PM                                                                                                                    
CHAIR MCGUIRE  announced the  consideration of  SB 113.  [This is                                                               
the first hearing and CSSB 113(HSS) is before the committee.]                                                                   
                                                                                                                                
1:50:27 PM                                                                                                                    
SENATOR  WIELECHOWSKI, Alaska  State  Legislature  sponsor of  SB                                                               
113,  introduced  the  bill speaking  to  the  following  sponsor                                                               
statement:                                                                                                                      
                                                                                                                                
     Senate Bill 113  would create a legal  climate in which                                                                    
     terminally  ill  patients   who  have  exhausted  other                                                                    
     available treatments  and do  not qualify  for clinical                                                                    
     trials   could  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 approval.                                                                                    
                                                                                                                                
     The   United  States   Food  and   Drug  Administration                                                                    
     currently    offers    an    "expanded    access"    or                                                                    
     "compassionate  use" exemption  that allows  terminally                                                                    
     ill  patients  that  meet certain  criteria  to  access                                                                    
     drugs  in  the  clinical  trial phase,  but  not  fully                                                                    
     approved. However, even with  recent efforts by the FDA                                                                    
     to streamline  the application process,  this exemption                                                                    
     program  is known  to be  arduous and  can take  longer                                                                    
     than patients facing terminal illness can wait.                                                                            
                                                                                                                                
     Since  2014, at  least 44  states have  seen "right  to                                                                    
     try"  legislation introduced,  12 of  which still  have                                                                    
     bills pending  and 25 of  which have signed  bills into                                                                    
     law   with  strong,   largely  unanimous,   bi-partisan                                                                    
     support.  It is  clear this  is a  human issue  and one                                                                    
     that goes beyond state and party lines.                                                                                    
                                                                                                                                
     In providing  terminal patients  the ability  to access                                                                    
     safe,  but experimental  drugs in  consultation with  a                                                                    
     doctor they trust,  this bill offers new  hope when all                                                                    
     FDA-approved options have been exhausted.                                                                                  
                                                                                                                                
SENATOR  WIELECHOWSKI  said this  bill  is  intended for  the  97                                                               
percent of  terminally ill people  who apply for  clinical trials                                                               
but are not accepted.                                                                                                           
                                                                                                                                
1:52:28 PM                                                                                                                    
BROOKE   IVY,   Staff,    Senator   Wielechowski   Alaska   State                                                               
Legislature, explained  that the goal  of SB  113 is to  create a                                                               
legal climate  so that  terminally ill  people can  work directly                                                               
with   their  doctor   and  the   drug  manufacturer   to  access                                                               
experimental drugs that have passed phase 1 of the FDA review                                                                   
process.                                                                                                                        
                                                                                                                                
MS. IVY reviewed the sections of SB 113.                                                                                        
                                                                                                                                
     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                                                                    
     consent.  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.                                                                                             
                                                                                                                                
     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.                                                                          
                                                                                                                                
1:55:12 PM                                                                                                                    
KURT  ALTMAN, Attorney,  Goldwater  Institute, Phoenix,  Arizona,                                                               
testified in support  of SB 113. He related he  is the drafter of                                                               
the model legislation  commonly referred to as "The  Right to Try                                                               
Bill" and he  has traveled across the country  advocating for the                                                               
legislation.   He  pointed   out  that   there  are   significant                                                               
protections  in the  bill  and that  this is  a  last chance  for                                                               
terminally  ill  patients.  For investigational  medicine  to  be                                                               
eligible  under right  to try  laws, it  has to  have passed  the                                                               
safety  testing  phase  1  of  the  FDA  approval  process.  More                                                               
importantly,  the drug  must be  in ongoing  phase 2  or phase  3                                                               
clinical trials. He confirmed that this  is for the 97 percent of                                                               
terminally ill  people who aren't accepted  into clinical trials.                                                               
By the end  of this legislative session, he expects  that quite a                                                               
few more  states will have  passed similar legislation.  This has                                                               
been a two to three year  process and patients are finally taking                                                               
advantage of right to try laws, he said.                                                                                        
                                                                                                                                
1:58:45 PM                                                                                                                    
SENATOR  COGHILL asked  if there  have been  liability issues  or                                                               
families that  feel somebody  has been  coerced into  a treatment                                                               
program.                                                                                                                        
                                                                                                                                
MR. ALTMAN said  there has been no litigation to  date with right                                                               
to try  laws. For someone to  receive a trial drug,  there has to                                                               
be  a detailed  informed  consent  on behalf  of  the doctor  and                                                               
patient.  In  practice, the  manufacturers  that  have agreed  to                                                               
provide  these   drugs  also  require  a   significant,  detailed                                                               
informed consent liability  waiver. Each law that  has passed has                                                               
a similar liability waiver as SB  113 for any adverse effect from                                                               
the  investigational  drug.  It  does not  waive  any  claims  of                                                               
medical malpractice.                                                                                                            
                                                                                                                                
SENATOR  COGHILL asked  how  the prohibition  in  Section 4  will                                                               
work.                                                                                                                           
                                                                                                                                
2:00:53 PM                                                                                                                    
MS.  IVY said  the provision  seeks to  allay concerns  of health                                                               
care  facilities and  hospitals  about  potentially losing  their                                                               
certificate for  Medicare or Medicaid.  Other states  have passed                                                               
this legislation  with a  similar provision.  She noted  that the                                                               
Department of  Health and Social  Services (DHSS)  has determined                                                               
that  SB  113  does  not  impact their  operations  due  to  that                                                               
provision in SB 113.                                                                                                            
                                                                                                                                
2:02:11 PM                                                                                                                    
MICHAEL   MAHARREY,   National  Communications   Director,   10th                                                               
Amendment Center,  testified in support  of SB 113. He  said that                                                               
when  the  Center  heard  about  the  issue  from  the  Goldwater                                                               
Institute, they  knew they could support  it without reservation.                                                               
SB  113  will  take  the   decision-making  process  regarding  a                                                               
patient's  treatment  options  out   of  the  hands  of  detached                                                               
individuals and  put it  where it belongs,  with the  patient and                                                               
their physician.  He commented  on the  FDA approval  process for                                                               
new drugs  that is  slow and cumbersome,  and described  right to                                                               
try  laws  as  a  bridge  that  spans  the  gap  between  federal                                                               
regulations and  the needs of  terminally ill patients.  He urged                                                               
the committee to pass SB 113.                                                                                                   
                                                                                                                                
2:04:52 PM                                                                                                                    
CHARLOTTE  WHITELEY, representing  herself, testified  in support                                                               
of SB 113.  She shared a story  about her father who  was able to                                                               
participate in  an experimental drug  trial that helped  him live                                                               
an extra  3 years. It was  particularly important to him  to know                                                               
that his  data would be used  to help future generations  who get                                                               
multiple myeloma.  She also described  the case of a  friend with                                                               
multiple  sclerosis   who  participated   in  a  drug   trial  in                                                               
Switzerland.  A new  and  better  drug is  being  developed as  a                                                               
result of that  trial. SB 113 allows people who  are going to die                                                               
from their disease, a chance to give to the future.                                                                             
                                                                                                                                
2:06:35 PM                                                                                                                    
KEN LANDFIELD,  representing himself, testified in  support of SB                                                               
113. He  said the  situation is  clear; the  bill is  designed to                                                               
provide  a last  ditch option  for someone  who is  going to  die                                                               
anyway. This  is an opportunity  for legislators to do  the right                                                               
thing and  it has no downside  he can see. Further,  it will cost                                                               
virtually nothing.                                                                                                              
                                                                                                                                
2:08:22 PM                                                                                                                    
CHAIR MCGUIRE  closed public  testimony on SB  113. She  shared a                                                               
story  about  her  physician  father who  made  the  decision  to                                                               
develop  a pilot  program  after the  FDA denied  the  use of  an                                                               
innovative scientific technique for his patients.                                                                               
                                                                                                                                
SENATOR COGHILL asked if a report goes  back to the FDA to add to                                                               
the data on the experimental drug                                                                                               
                                                                                                                                
MS. IVY said  SB 113 does not include  reporting requirements but                                                               
her understanding  is that it  is a requirement in  the contracts                                                               
with  manufacturers under  both  compassionate use  and right  to                                                               
try.                                                                                                                            
                                                                                                                                
SENATOR COGHILL expressed satisfaction.                                                                                         
                                                                                                                                
CHAIR MCGUIRE commented  further on the pilot  program her father                                                               
developed.                                                                                                                      
                                                                                                                                
2:13:23 PM                                                                                                                    
SENATOR COGHILL  moved to report the  CS for SB 113,  labeled 29-                                                               
LS0783\E,  from  committee  with individual  recommendations  and                                                               
attached fiscal note(s).                                                                                                        
                                                                                                                                
2:14:04 PM                                                                                                                    
SENATOR WIELECHOWSKI said  he was surprised and  pleased to learn                                                               
that  the  Goldwater  Institute   supports  the  legislation.  He                                                               
credited  his   staff  for   doing  comprehensive   research  and                                                               
described SB  113 as  good legislation that  could save  lives in                                                               
Alaska.                                                                                                                         
                                                                                                                                
2:14:25 PM                                                                                                                    
CHAIR MCGUIRE announced that without  objection, CSSB 113(HSS) is                                                               
reported from Senate Judiciary Standing Committee.                                                                              

Document Name Date/Time Subjects
SB 113 Explanation of Changes ver A to ver H.pdf SJUD 4/11/2016 1:30:00 PM
SB 113
SB 113 Fiscal Note - DCCED-CBPL-02-19-16.pdf SJUD 4/11/2016 1:30:00 PM
SB 113
SB 113 Supporting Document - Legislative Map 3-31-16.pdf SJUD 4/11/2016 1:30:00 PM
SB 113
SB 113 Supporting Document - Letter of Support Charlotte Whiteley 2-24-16.pdf SJUD 4/11/2016 1:30:00 PM
SB 113
SB211 - Version A.pdf SJUD 4/11/2016 1:30:00 PM
SB 211
SB211 Sectional Analysis.pdf SJUD 4/11/2016 1:30:00 PM
SB 211
SB211 Sponsor Statement.pdf SJUD 4/11/2016 1:30:00 PM
SB 211
SB211 Supporting Document - Alaska Policy Forum Report.pdf SJUD 4/11/2016 1:30:00 PM
SB 211
SB211 Supporting Document - Alaska Bar Rag Article.pdf SJUD 4/11/2016 1:30:00 PM
SB 211
SB211 Sponsor Statement.pdf SJUD 4/11/2016 1:30:00 PM
SB 211
CSSB113 ver E (HSS).pdf SJUD 4/11/2016 1:30:00 PM
SB 113
SB 113 ver E Sectional Analysis.pdf SJUD 4/11/2016 1:30:00 PM
SB 113
SB 113 Explanation of Changes A to E.pdf SJUD 4/11/2016 1:30:00 PM
SB 113
SB211 - Version W.pdf SJUD 4/11/2016 1:30:00 PM
SB 211
SB211 Explanation of Changes Version A to W.pdf SJUD 4/11/2016 1:30:00 PM
SB 211
SB211 Sectional Analysis Ver W.pdf SJUD 4/11/2016 1:30:00 PM
SB 211
SB 113 - Opposing Document - Letter from Alaska State Medical Board - 4-7-16.pdf SJUD 4/11/2016 1:30:00 PM
SB 113
SB 113 - Supporting Document - Sen Wielechowski to Alaska State Medical Board - 4-11-16.pdf SJUD 4/11/2016 1:30:00 PM
SB 113