Legislature(2017 - 2018)BELTZ 105 (TSBldg)

02/28/2018 01:30 PM JUDICIARY

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Heard & Held
Heard & Held
+ Bills Previously Heard/Scheduled TELECONFERENCED
            HB  43-NEW DRUGS FOR THE TERMINALLY ILL                                                                         
2:45:36 PM                                                                                                                    
CHAIR COGHILL announced the consideration of HB 43.                                                                             
2:46:15 PM                                                                                                                    
REPRESENTATIVE  JASON  GRENN,  Alaska State  Legislature  Juneau,                                                               
Alaska, sponsor of HB 43,  introduced the legislation speaking to                                                               
the following 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                                                                    
     More  than  1 million  Americans  die  from a  terminal                                                                    
     illness every  year. Many spend  years searching  for a                                                                    
     potential  cure, or  struggle in  vain to  get accepted                                                                    
     into a clinical trial.  Unfortunately, FDA red tape and                                                                    
     government  regulations can  often  restrict access  to                                                                    
     promising new  treatments, and sometimes for  those who                                                                    
     do get access, it is too late.                                                                                             
     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.  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 have to wait.                                                                                             
     Since  2014,  38  states have  signed  "right  to  try"                                                                    
     legislation into law  with strong, bi-partisan support.                                                                    
     It  is clear  this is  a human  issue that  goes beyond                                                                    
     state  and  party  lines, and  could  provide  Alaskans                                                                    
     increased access to  potentially life-saving treatments                                                                    
     in the times they need it most.                                                                                            
     In  allowing  Alaskans   facing  terminal  illness  the                                                                    
     ability to  access safe,  though experimental  drugs in                                                                    
     consultation  with  a  doctor  they  trust,  this  bill                                                                    
     offers  new hope  when  all  FDA-approved options  have                                                                    
     been exhausted. I urge your support of House Bill 43.                                                                      
REPRESENTATIVE GRENN read a letter of support from a                                                                            
     I  write to  you today  in support  of HB  43 with  the                                                                    
     short  title, "New  Drugs for  the Terminally  Ill." In                                                                    
     June 2011, my father  was diagnosed with ALS, sometimes                                                                    
     known as  Lou Gehrig's  disease. For  those unfamiliar,                                                                    
     this disease  slowly saps a  person's ability  to move,                                                                    
     rendering  them bed-ridden.  Eventually  it takes  away                                                                    
     their ability to  breathe at which point  they die. For                                                                    
     my father, this deterioration began in June.                                                                               
     He had been  working 12 hours days, five or  six days a                                                                    
     week as  a machinist. He  was, by all accounts,  a very                                                                    
     strong and health man at  the time of his diagnosis. By                                                                    
     late fall he  had completely lost his  ability to walk.                                                                    
     At  Thanksgiving, he  held out  five-month-old son  for                                                                    
     the last time  in his arms as he had  become to weak to                                                                    
     be trusted  with such precious cargo.  In early morning                                                                    
     of February 1,  2012, he died at the all  too young age                                                                    
     of 58.                                                                                                                     
     In the end I wish the  State had afforded him the right                                                                    
     to fight  his disease. Recently in  the Washington Post                                                                    
     there was an article detailing  the experience of a man                                                                    
     who  had,  for all  intents  and  purposes, beaten  ALS                                                                    
     through advance  therapies pioneered by doctors  at the                                                                    
     ALS Center  in Atlanta, Georgia. In  reading about this                                                                    
     man, I  became aware  of the Right  to Try  movement. I                                                                    
     cannot say  for sure  that these advance  therapies may                                                                    
     have  saved my  father's life,  but they  may yet  same                                                                    
     someone's father, mother, daughter, or son.                                                                                
     Thank  you for  your  consideration  on this  important                                                                    
REPRESENTATIVE GRENN stated that the goal  of HB 43 is to provide                                                               
the same access as the FDA's  Compassionate Use Program, but on a                                                               
shorter  timeline. That  program  recognizes that  97 percent  of                                                               
people are not accepted in clinical  trials. HB 43 seeks to offer                                                               
new  hope  when   all  other  FDA  approved   options  have  been                                                               
2:50:15 PM                                                                                                                    
BROOKE  IVY,  Staff,  Representative Jason  Grenn,  Alaska  State                                                               
Legislature Juneau,  Alaska, paraphrased the  following sectional                                                               
analysis for HB 43:                                                                                                             
     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.                                                                          
CHAIR COGHILL  asked if 97  percent of Alaskans have  been denied                                                               
clinical trials.                                                                                                                
MS.  IVY  replied  that  is  a national  number.  She  noted  the                                                               
clinical trials  document in the  packet has stories  of Alaskans                                                               
who have been admitted into clinical trials.                                                                                    
CHAIR COGHILL asked her to discuss the FDA drug review process.                                                                 
MS.  IVY explained  that when  a drug  manufacturer's application                                                               
for  an investigational  new  drug (IND)  is  accepted, the  drug                                                               
moves  into  phase 1.  The  drug  is  studied for  possible  side                                                               
effects and toxicity levels on  healthy volunteers. Phase 2 looks                                                               
at how effective the drug is for the condition. Phase 3 looks at                                                                
safety again as well as effectiveness.                                                                                          
CHAIR COGHILL asked if the informed consent form tells an                                                                       
individual they are part of a trial.                                                                                            
2:55:22 PM                                                                                                                    
MS. IVY clarified that the volunteer would not be in a clinical                                                                 
trial, but the data related to the experimental drug would be                                                                   
collected and sent to the FDA.                                                                                                  
2:57:32 PM                                                                                                                    
CHAIR COGHILL held HB 43 in committee.                                                                                          

Document Name Date/Time Subjects
SB 173 - Sponsor Statement.pdf SJUD 2/28/2018 1:30:00 PM
SB 173
SB 173 - Explanation of Changes (ver. A to ver. J).PDF SJUD 2/28/2018 1:30:00 PM
SB 173
SB 173 - Letters of Support.pdf SJUD 2/28/2018 1:30:00 PM
SB 173
SB 173 - Sectional Summary (ver. J).PDF SJUD 2/28/2018 1:30:00 PM
SB 173
HB 43 - Supporting Document - FDA Drug Review Process.pdf SJUD 2/28/2018 1:30:00 PM
HB 43
HB 43 - Supporting Document - Clinical Trials in Alaska.pdf SJUD 2/28/2018 1:30:00 PM
HB 43
HB 43 - Supporting Document - Goldwater Institute Fact Sheet.pdf SJUD 2/28/2018 1:30:00 PM
HB 43
HB 43 - Supporting Document - Goldwater Institute Patient Stories.pdf SJUD 2/28/2018 1:30:00 PM
HB 43
HB 43 - Supporting Document - Legislative Map.pdf SJUD 2/28/2018 1:30:00 PM
HB 43
HB 43 - Supporting Document - Letter from Premera.pdf SJUD 2/28/2018 1:30:00 PM
HB 43
HB 43 - Explanation of Changes (ver. D to ver. J).pdf SJUD 2/28/2018 1:30:00 PM
HB 43
HB 43 - Letters of Support.pdf SJUD 2/28/2018 1:30:00 PM
HB 43
HB 43 - Presentation.pdf SJUD 2/28/2018 1:30:00 PM
HB 43
HB 43 - Sectional Analysis (ver. J).pdf SJUD 2/28/2018 1:30:00 PM
HB 43
HB 43 - Sponsor Statement.pdf SJUD 2/28/2018 1:30:00 PM
HB 43