Legislature(2015 - 2016)BUTROVICH 205

02/24/2016 01:30 PM HEALTH & SOCIAL SERVICES

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* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
*+ SB 113 NEW DRUGS FOR THE TERMINALLY ILL TELECONFERENCED
Heard & Held
*+ SB 156 INSURANCE COVERAGE FOR CONTRACEPTIVES TELECONFERENCED
Heard & Held
+ Bills Previously Heard/Scheduled TELECONFERENCED
            SB 113-NEW DRUGS FOR THE TERMINALLY ILL                                                                         
                                                                                                                                
1:32:09 PM                                                                                                                    
CHAIR STEDMAN announced the consideration of SB 113.                                                                            
                                                                                                                                
1:32:59 PM                                                                                                                    
SENATOR GIESSEL  moved to adopt  the CS  for SB 113,  labeled 29-                                                               
LS0783\H, as the document before the committee.                                                                                 
                                                                                                                                
CHAIR STEDMAN objected for discussion.                                                                                          
                                                                                                                                
1:33:17 PM                                                                                                                    
SENATOR BILL WIELECHOWSKI, Alaska  State Legislature, as sponsor,                                                               
introduced SB  113. He noted that  the bill is called  the "Right                                                               
to  Try Act."  It allows  terminally  ill patients  to work  with                                                               
their  doctors  and  drug  or   device  manufacturers  to  access                                                               
investigational  treatments that  have  passed  the Federal  Drug                                                               
Administration's (FDA) safety  testing phase - Phase 1  - but are                                                               
not  yet widely  available.  More than  a  million Americans  die                                                               
every year from terminal illness.                                                                                               
                                                                                                                                
CHAIR STEDMAN requested to hear the change made in the CS.                                                                      
                                                                                                                                
1:34:06 PM                                                                                                                    
BROOKE   IVY,   Staff,   Senator   Wielechowski,   Alaska   State                                                               
Legislature, explained  the changes in  version H of SB  113. She                                                               
reported  that  SB  113  has had  three  iterations;  version  A,                                                               
version W,  and now version H.  She related that in  version H on                                                               
page 1,  line 10,  provisions to prevent  any damage  to clinical                                                               
trial  participation were  added  by ensuring  that patients  had                                                               
already  attempted to  enter a  clinical trial.  The language  in                                                               
Section 1 states  that patients must be "ineligible  or unable to                                                               
participate in a clinical trial" as part of their condition.                                                                    
                                                                                                                                
MS. IVY related that on page  2 of Section 1, the requirement for                                                               
hospitals and healthcare facilities  to participate was repealed.                                                               
Language was added that the  investigational drug shall remain in                                                               
an  on-going  clinical  trial  in   order  to  clarify  that  the                                                               
investigational  drug  is in  Phase  2  or  Phase  3 of  the  FDA                                                               
approval process.                                                                                                               
                                                                                                                                
She said  on page  2, line 21,  immunity protections  for medical                                                               
team members,  in addition to  physicians, was added. On  page 3,                                                               
line 12, a fourth section  was added because the previous section                                                               
was repealed.  Section 4  says it is  optional for  hospitals and                                                               
healthcare  facilities to  participate  in  order to  accommodate                                                               
physicians    prescribing,     dispensing,    or    administering                                                               
investigational drugs to a patient,  and DHSS cannot require them                                                               
to do so.                                                                                                                       
                                                                                                                                
1:36:39 PM                                                                                                                    
MS.  IVY said  in  Section 4  of  version W,  it  stated that  "a                                                               
licensed  entity  may  not  be subject  to  investigation  or  an                                                               
enforcement action  for failing  to increase services."  The only                                                               
change  from  version  W  to  version  H  was  stating  that  the                                                               
department may not be required to provide additional services.                                                                  
                                                                                                                                
1:37:20 PM                                                                                                                    
CHAIR  STEDMAN  removed his  objection.  There  being no  further                                                               
objection, version H was adopted.                                                                                               
                                                                                                                                
He noted the presence of Senator Stoltz.                                                                                        
                                                                                                                                
1:38:22 PM                                                                                                                    
SENATOR WIELECHOWSKI  explained the  origins of  SB 113.  He said                                                               
the bill is known as the "Right  to Try Act" and has passed in 24                                                               
states and  been introduced  in virtually  every other  state. He                                                               
related  that  SB 113  sets  up  a  legal framework  that  allows                                                               
terminally ill patients  to work with their doctors  and drug and                                                               
device  manufacturers to  access investigational  treatments that                                                               
have  been passed  the FDA's  safety testing  phase, but  are not                                                               
widely  available. It  would expand  access to  potentially life-                                                               
saving treatments  years before  patients would normally  be able                                                               
to access  them. The problem  is the bureaucratic process  in the                                                               
FDA can  take years, and fewer  than 3 percent of  terminally ill                                                               
patients gain access to treatments  through clinical trials. This                                                               
legislation  is  designed  to   try  and  make  those  treatments                                                               
available to the other 97 percent.                                                                                              
                                                                                                                                
He  noted he  worked  on  the legislation  with  Kurt Altman,  an                                                               
expert  from the  Goldwater Institute  in Arizona.  He emphasized                                                               
that this issue  cuts across party lines.  It enjoys overwhelming                                                               
bi-partisan support in the states where it has passed.                                                                          
                                                                                                                                
MS. IVY explained that the goal of  the bill is to create a legal                                                               
climate in which terminally ill  patients, who have exhausted all                                                               
FDA-approved treatment  options, may work with  their doctors and                                                               
drug  manufacturers  to  access investigational  treatments  that                                                               
have passed Phase 1 of the  FDA approval process, but are not yet                                                               
widely available.                                                                                                               
                                                                                                                                
MS. IVY said version H has four sections:                                                                                       
                                                                                                                                
Section  1 of  the bill  prohibits the  State Medical  Board from                                                               
taking disciplinary action against  physicians for prescribing or                                                               
administering  an  investigational  drug   to  a  terminally  ill                                                               
patient that meets certain criteria.  Patients under this section                                                               
must  be  ineligible  or  unable to  participate  in  an  ongoing                                                               
clinical  trial, have  considered  all  other approved  treatment                                                               
options and have provided written consent.                                                                                      
                                                                                                                                
Section  2,  a   new  section  in  AS   09.65,  establishes  that                                                             
physicians,  medical team  members, manufacturers,  importers and                                                               
distributors, "acting  in good faith  and with  reasonable care,"                                                               
will not  be held  liable in  the case  of injury  or death  of a                                                               
terminally ill patient  from the use of  an investigational drug,                                                               
provided  that informed  consent was  obtained from  the patient,                                                               
and  notice  of  immunity  was  also given  to  the  patient,  in                                                               
advance.                                                                                                                        
                                                                                                                                
Section 3 adds a new section  to AS 17.20.110, a statute limiting                                                               
the sale  and distribution of  new drugs.   The new  section will                                                               
allow  physicians  to  prescribe  or  administer  investigational                                                               
drugs under the conditions established in Section 1.                                                                            
                                                                                                                                
Finally, Section  4 would  prevent the  Department of  Health and                                                               
Social Services  from requiring a  licensed health  care facility                                                               
to  increase its  services solely  to accommodate  physicians who                                                               
are  prescribing  or  administering investigational  drugs  to  a                                                               
patient.                                                                                                                        
                                                                                                                                
1:42:12 PM                                                                                                                    
MS. IVY reviewed the four phases of the FDA drug review process:                                                                
                                                                                                                                
Prior  to Phase  1 is  when sponsors  of a  drug are  required to                                                               
submit  what's  called  an  Investigational  New  Drug  (or  IND)                                                               
Application  - it  is through  this application  process the  FDA                                                               
reviews   the  applicant's   preclinical   testing  results   and                                                               
determines whether  the drug  is reasonably  safe for  testing in                                                               
humans.                                                                                                                         
                                                                                                                                
Phase 1 studies  occur after the approval  of the Investigational                                                               
New Drug Application.  These studies may be  conducted on healthy                                                               
volunteers in cases  of testing on drugs like  ibuprofen or anti-                                                               
inflammatories,  or on  individuals  with a  specific disease  or                                                               
terminal illness.   The goal of  Phase 1 testing is  to determine                                                               
possible  side effects  and toxicity  levels. Basically,  Phase 1                                                               
focuses on safety.                                                                                                              
                                                                                                                                
Phase  2  studies  begin  when  a drug  passes  Phase  1  and  is                                                             
therefore  considered relatively  safe (no  unacceptable toxicity                                                               
levels). While  Phase 1 focuses on  safety, Phase 2 focuses  on a                                                               
drug's effectiveness.                                                                                                           
                                                                                                                                
If there is  evidence a drug is effective, it  will then progress                                                               
to Phase  3. This is where  more information is gained  on safety                                                               
and  effectiveness,  particularly   in  varying  populations,  at                                                               
different dosages and in combination with other medications.                                                                    
                                                                                                                                
After Phase  3, sponsors of the  drug then have a  review meeting                                                               
with  the FDA,  and go  on to  complete a  New Drug  Application,                                                               
which if  approved, would allow  them to  market the drug  in the                                                               
United States. From  there the FDA has 60 days  to decide whether                                                               
to  officially  "file"  the application  for  review.  If  filed,                                                               
applications are generally processed within 10 months.                                                                          
                                                                                                                                
1:44:24 PM                                                                                                                    
                                                                                                                                
MS. IVY explained  that when the term  "investigational drugs" is                                                               
used in  Senate Bill 113,  it refers to those  experimental drugs                                                               
that have  passed safety testing in  Phase 1, and that  remain in                                                               
ongoing clinical trials  in either Phase 2 or Phase  3 of the FDA                                                               
approval process.                                                                                                               
                                                                                                                                
She addressed  the purpose of  the legislation. Each year,  it is                                                               
estimated that  over one  million Americans  die from  a terminal                                                               
illness. Many  individuals diagnosed  with a fatal  condition may                                                               
spend years  searching for  a cure  or a  viable treatment.   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  a 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's                                                               
estimated  that only  about  1,000 people  make  it through  this                                                               
federal process each year.                                                                                                      
                                                                                                                                
By the FDA's  own estimate, the program's  application form alone                                                               
can take  100 hours  for a  doctor to complete.  In an  effort to                                                               
streamline the  process, the FDA  did announce plans  in February                                                               
of  2015 to  shorten the  application.  However, a  year has  now                                                               
passed  and the  new  form  has yet  to  be  made available.  The                                                               
application  is  only the  first  step.  Manufacturers must  also                                                               
submit   lengthy   documentation.  Once   complete,   application                                                               
paperwork must then  make its way through the FDA,  and then to a                                                               
separate  Institutional  Review  Board  for  approval,  an  often                                                               
lengthy, multi-month process.                                                                                                   
                                                                                                                                
1:46:38 PM                                                                                                                    
She stated that  given this information, the goal  of Senate Bill                                                               
113  is  to  provide  the  same  access  as  the  FDA's  existing                                                               
"compassionate  use"   program,  but  on  shorter   timeline.  By                                                               
ensuring  terminally  ill patients  have  more  timely access  to                                                               
safe, but experimental drugs, in  consultation with their doctor,                                                               
SB 113 attempts  to offer new hope when  all FDA-approved options                                                               
have been exhausted                                                                                                             
                                                                                                                                
She noted items in members' packets:                                                                                            
                                                                                                                                
   1) An Updated NCSL Legislative Map (1-4-2016). Although this                                                                 
                                   th                                                                                           
     map was published on January 4   of this year, it is already                                                               
     out of date. As of today,  47 states have now seen "Right to                                                               
     Try" legislation either introduced or  passed.  Of those, 24                                                               
     states  have  signed  the  "Right  to  Try"  into  law  with                                                               
     overwhelming bi-partisan, and often unanimous, support.                                                                    
     The Indiana  - (H),  Georgia -  (H), Texas  - (S),  Nevada -                                                               
     (H&S),  North  Carolina  -  (H&S) are  just  a  sampling  of                                                               
     legislative bodies  that put their unanimous  support behind                                                               
     the  "Right   to  Try."  22   states  also   currently  have                                                               
     legislation  pending, including  Alaska.    For the  record,                                                               
     this now  adds WA, ID, KS,  KY, WV, GA,  SC, MD, RI &  VT to                                                               
     the map as "pending."  Please  also note the map contains an                                                               
     error: NH has  not yet passed the "Right to  Try," but it is                                                               
     currently pending.                                                                                                         
                                                                                                                                
   2) Sponsor Statement - note that state legislation numbers                                                                   
     reference  in the  sponsor statement,  being  based on  this                                                               
     map, are now incorrect.                                                                                                    
                                                                                                                                
   3) Goldwater Institute Policy Report - an abbreviated version                                                              
     of the Goldwater Institute's Policy Report.                                                                                
                                                                                                                                
     The  Policy   Report  goes  into   greater  detail   on  the                                                               
     challenges  of the  FDA's "compassionate  use" program,  and                                                               
     tells the  story of Kianna  Karnes, a 41 year  old diagnosed                                                               
     with kidney cancer who passed  away before she could receive                                                               
     access to an investigational drug  that may have helped her.                                                               
     To read a quick excerpt from the executive summary:                                                                        
                                                                                                                                
     "In the case of Kianna Karnes,  she had a better chance than                                                               
     most patients  at receiving expanded  access. As  her father                                                               
     explained,  "Here is  a case  where her  old man  understood                                                               
     clinical trials.  I knew  about compassionate  use; I  had a                                                               
     friendship with a powerful member  of Congress; I've got the                                                               
     Wall Street  Journal behind  me. But  I still  couldn't save                                                               
     her life. Now, what about  the thousands of people out there                                                               
     who don't have these kinds  of resources available to them?"                                                               
     To  most  patients, and  many  physicians  outside of  major                                                               
     institutions, the  process of  obtaining expanded  access is                                                               
     excessively  time-consuming   and  extremely   difficult  to                                                               
     navigate."                                                                                                                 
                                                                                                                                
     For those  members who  are interested,  the full  report is                                                               
     now available on Basis.                                                                                                    
                                                                                                                                
   4) Clinical Trials - a document entitled "Clinical Trials."                                                                  
     While SB 113  focuses on terminally ill patients  who do not                                                               
     qualify for clinical trials, we  felt the inclusion of these                                                               
     Alaskan stories  would help to illustrate  local experiences                                                               
     with  terminal illness,  as well  as the  benefit of  simply                                                               
     having access  to new treatment  options, clinical  trial or                                                               
     not.                                                                                                                       
                                                                                                                                
1:49:50 PM                                                                                                                    
SENATOR  STOLTZE requested  a definition  of biological  products                                                               
and information whether FDA's testing  "not doing harm" must also                                                               
"show that it does good."                                                                                                       
                                                                                                                                
1:50:28 PM                                                                                                                    
MS. IVY deferred to Mr. Altman to answer.                                                                                       
                                                                                                                                
SENATOR STOLTZE voiced concern about  product contents leading to                                                               
false hopes.                                                                                                                    
                                                                                                                                
CHAIR STEDMAN opened public testimony.                                                                                          
                                                                                                                                
1:52:45 PM                                                                                                                    
KURT ALTMAN, Counsel,  Goldwater Institute, presented information                                                               
about SB 112. He said he  is the drafter of the model legislation                                                               
SB  113 is  generally fashioned  after. He  said he  has been  to                                                               
about  30   to  35   states  and   has  met   with  stakeholders,                                                               
legislators,   legal   panels,    FDA   doctors,   pharmaceutical                                                               
companies,  and  insurance  companies  for about  two  years.  He                                                               
explained that  the bill  would allow  terminal patients,  on the                                                               
recommendation  of their  physicians,  to access  investigational                                                               
new drugs, biologics, or devices that  have passed Phase 1 of FDA                                                               
testing  and remain  in the  testing  process. He  said a  common                                                               
misperception is that a drug can  pass Phase 1 and be marketed to                                                               
desperate  people. The  "Right to  Try" was  designed to  prevent                                                               
that and there  are a number of safeguards. A  company cannot get                                                               
a drug through Phase 1 and then market it to the public.                                                                        
                                                                                                                                
1:56:24 PM                                                                                                                    
MR. ALTMAN  continued to  describe the  FDA approval  process and                                                               
stressed that  the bill does  not take people away  from clinical                                                               
trials. He  used the cell phone  as an example of  how technology                                                               
has  advanced and  compared it  to  medical technology  advances,                                                               
which  have often  outpaced the  FDA process.  Many drugs  are in                                                               
their 12th  year of clinical  trials and it is  nearly impossible                                                               
for  patients to  access those  drugs.  The bill  would keep  the                                                               
access to these drugs between the doctor and the patient.                                                                       
                                                                                                                                
1:58:37 PM                                                                                                                    
MR. ALTMAN defined biological products  as cells - plant or human                                                               
-  that  are  injected  into  the   body.  He  said  there  is  a                                                               
significant concern about charlatans  trying to take advantage of                                                               
desperate people.  Right to Try  has made that  nearly impossible                                                               
because the drug has to pass FDA's  Phase 1 and remain in Phase 2                                                               
or  3.  That means  it  is  a legitimate  drug  and  it would  be                                                               
provided  for free  or for  cost of  production. Federal  statute                                                               
prohibits any  profit to a  company for sale  of a drug  that has                                                               
not  been  officially  approve  for  marketing.  The  process  is                                                               
designed not to make money off of desperate people.                                                                             
                                                                                                                                
2:01:16 PM                                                                                                                    
SENATOR  STOLTZE asked  if the  cells  could be  from an  aborted                                                               
child.                                                                                                                          
                                                                                                                                
MR. ALTMAN said no.                                                                                                             
                                                                                                                                
SENATOR STOLTZE questioned, "Absolutely no?"                                                                                    
                                                                                                                                
MR. ALTMAN replied, "Absolutely no."                                                                                            
                                                                                                                                
2:02:20 PM                                                                                                                    
MICHAEL   MAHARREY,   National  Communications   Director,   10th                                                               
Amendment Center,  testified in  support of SB  113. He  said his                                                               
organization has been  involved in, and supportive  of, the Right                                                               
to Try from the beginning.  He provided statistics related to the                                                               
time it  takes to  get a  drug approved.  He said  the bill  is a                                                               
perfect example of states exercising  their rightful authority to                                                               
exercise control over  local issues. It would  expanded access to                                                               
treatments for the desperately ill.                                                                                             
                                                                                                                                
2:05:47 PM                                                                                                                    
KEN LANDFIELD,  representing himself, testified in  support of SB                                                               
113.  He referred  to the  Hippocratic Oath  to do  no harm,  and                                                               
wondered how much  harm could be done to a  terminally ill person                                                               
under guidance  of their physician.  He thought the Right  to Try                                                               
should be an option.                                                                                                            
                                                                                                                                
SENATOR  WIELECHOWSKI  said  he appreciated  the  opportunity  to                                                               
present  SB  113. He  concluded  it  is  an important  bill  that                                                               
crosses party lines and potentially saves lives.                                                                                
                                                                                                                                
CHAIR STEDMAN held SB 113 in committee.                                                                                         
                                                                                                                                

Document Name Date/Time Subjects
SB 156.pdf SHSS 2/24/2016 1:30:00 PM
SB 156
SB 156 Sponsor Statement.pdf SHSS 2/24/2016 1:30:00 PM
SB 156
SB 156 sectional analysis.pdf SHSS 2/24/2016 1:30:00 PM
SB 156
SB 156 Guttmacher_Alaska Stats.pdf SHSS 2/24/2016 1:30:00 PM
SB 156
SB 156 Guttmacher - general.pdf SHSS 2/24/2016 1:30:00 PM
SB 156
SB 156 CDC_Unintended Pregnancy.pdf SHSS 2/24/2016 1:30:00 PM
SB 156
SB 156 American Journal of Public Health.pdf SHSS 2/24/2016 1:30:00 PM
SB 156
SB 156 Medicaid Family planning Eligibility Expansion - Guttmacher.pdf SHSS 2/24/2016 1:30:00 PM
SB 156
SB 156 ADN commentary.PDF SHSS 2/24/2016 1:30:00 PM
SB 156
SB 156 Military rates.pdf SHSS 2/24/2016 1:30:00 PM
SB 156
SB 156 Letter of support - League of Women Voters.PDF SHSS 2/24/2016 1:30:00 PM
SB 156
SB 156 Letter of Opposition NFIB.PDF SHSS 2/24/2016 1:30:00 PM
SB 156
SB 156 issue-brief-private-insurance-coverage-of-contraception.pdf SHSS 2/24/2016 1:30:00 PM
SB 156
SB 113 Sponsor Statement.pdf SHSS 2/24/2016 1:30:00 PM
SB 113
SB113 ver H.pdf SHSS 2/24/2016 1:30:00 PM
SB 113
SB 113 ver H Sectional Analysis.pdf SHSS 2/24/2016 1:30:00 PM
SB 113
SB 113 Supporting Document - NCSL State Laws & Legislation Report 3-31-15.pdf SHSS 2/24/2016 1:30:00 PM
SB 113
SB 113 - updated NCSL Legislative Map 1-4-16.pdf SHSS 2/24/2016 1:30:00 PM
SB 113
SB 113 Supporting Document - Goldwater Institute Fact Sheet.pdf SHSS 2/24/2016 1:30:00 PM
SB 113
SB 113 Supporting Document - Goldwater Institute Patient Stories.pdf SHSS 2/24/2016 1:30:00 PM
SB 113
SB 113 Supporting Document - Goldwater Institute Policy Report Summary - 2-11-14.pdf SHSS 2/24/2016 1:30:00 PM
SB 113
SB 113 Supporting Document - FDA Drug Review Process.pdf SHSS 2/24/2016 1:30:00 PM
SB 113
SB 156 Washington House Passes 12-Month Supplies of Birth Control.pdf SHSS 2/24/2016 1:30:00 PM
SB 156
SB 156 Side Effects_Hormonal Contraception.pdf SHSS 2/24/2016 1:30:00 PM
SB 156
SB 156 Letter of Conern Carolyn Brown.PDF SHSS 2/24/2016 1:30:00 PM
SB 156
SB 156 Letter of Support APRN.pdf SHSS 2/24/2016 1:30:00 PM
SB 156
SB 156 fiscalNote.pdf SHSS 2/24/2016 1:30:00 PM
SB 156
SB 113 Supporting Document - Letter of Support 10th Amendment Center 2-9-16.pdf SHSS 2/24/2016 1:30:00 PM
SB 113
SB 113 Supporting Document - Letter of Support Dixie Hood 1-30-16.pdf SHSS 2/24/2016 1:30:00 PM
SB 113
SB 113 Supporting Document - Letter of Support Dr. Huang 2-1-16.pdf SHSS 2/24/2016 1:30:00 PM
SB 113
SB 113 Supporting Document - Letter of Support Dr. Urata 2-1-16.pdf SHSS 2/24/2016 1:30:00 PM
SB 113
SB 113 Supporting Document - Clinical Trials in Alaska.pdf SHSS 2/24/2016 1:30:00 PM
SB 113
SB 113 Supporting Document - Goldwater Institute Policy Report - 2-11-14.pdf SHSS 2/24/2016 1:30:00 PM
SB 113