03/02/2017 03:00 PM House HEALTH & SOCIAL SERVICES

             HB 43-NEW DRUGS FOR THE TERMINALLY ILL                                                                         
                                                                                                                                
4:00:30 PM                                                                                                                    
                                                                                                                                
CHAIR SPOHNHOLZ announced  that the next order  of business would                                                               
be  HOUSE  BILL   NO.  43,  "An  Act   relating  to  prescribing,                                                               
dispensing,   and   administering    an   investigational   drug,                                                               
biological product, or device by  physicians for patients who are                                                               
terminally  ill;  providing  immunity related  to  manufacturing,                                                               
distributing,  or  providing  investigational  drugs,  biological                                                               
products,  or  devices;  and relating  to  licensed  health  care                                                               
facility requirements."                                                                                                         
                                                                                                                                
4:00:49 PM                                                                                                                    
                                                                                                                                
BROOKE  IVY,  Staff,  Representative Jason  Grenn,  Alaska  State                                                               
Legislature,  stated that  this  legislation essentially  allowed                                                               
terminally ill  patients to work  with their doctors and  drug or                                                               
device  manufacturers to  access investigational  treatments that                                                               
had passed  the safety testing  phase, Phase  1 of the  FDA (U.S.                                                               
Food and Drug  Administration) approval process, but  had not yet                                                               
passed Phase 2 and Phase 3  and were currently in ongoing trials,                                                               
hence were not yet widely available  for public access.  She said                                                               
that  this   could  expand   access  to   potentially  lifesaving                                                               
treatments  years before  normal  access.   She  stated that,  as                                                               
fewer than  3 percent of  those patients diagnosed  as terminally                                                               
ill who  tried to access  clinical trials were accepted  based on                                                               
the level of illness, this  legislation would affect the other 97                                                               
percent.   She  added that  a compassionate  use program  already                                                               
existed  with  the FDA,  which  allowed  for application  by  the                                                               
doctor, although it  was known to be a lengthy  process which did                                                               
not work well for those people with terminal illness.                                                                           
                                                                                                                                
4:02:26 PM                                                                                                                    
                                                                                                                                
REPRESENTATIVE   SADDLER  stated   that  mediation   was  already                                                               
required  between a  health  care provider  and  a patient  which                                                               
allowed for  a process of  testing and validation of  drugs which                                                               
the provider suggested.  He asked  if this was an argument for no                                                               
remediation  in  order  to  allow   a  patient  to  try  whatever                                                               
substance  they thought  would help  save their  life or  improve                                                               
their health.                                                                                                                   
                                                                                                                                
MS. IVY  replied that  the actual language  of the  proposed bill                                                               
defined  a  very  specific  situation for  someone  to  have  the                                                               
ability to access this.   She reiterated that currently there was                                                               
a compassionate use application through  the FDA, although it was                                                               
strictly  for  individuals  diagnosed as  terminally  ill,  which                                                               
required  conference  with  their  doctor, and  then  involved  a                                                               
lengthy  FDA  process  and  institutional   review  board.    The                                                               
proposed  bill   would  maintain  that  the   diagnosis  was  for                                                               
terminally  ill and  that  the patient  had  exhausted all  other                                                               
approved  options, in  consultation  with the  doctor, and  would                                                               
then require  consent of  the doctor, the  patient, and  the drug                                                               
manufacturer for access to those medications.                                                                                   
                                                                                                                                
REPRESENTATIVE CLAMAN  asked why  this was limited  to terminally                                                               
ill  patients, if  someone was  willing to  try the  experimental                                                               
options.                                                                                                                        
                                                                                                                                
MS. IVY  said that this question  had come up previously  and had                                                               
been  discussed  in other  states.    She reported  that  similar                                                               
legislation had passed  in 33 states, and that  this narrow focus                                                               
was more likely  to be supported in the courts.   She stated that                                                               
otherwise,  this  was,  in  essence,  opening  up  the  FDA  drug                                                               
approval process  and created a  larger policy  conversation than                                                               
the proposed bill wanted to tackle.   She added that the proposed                                                               
bill focused on  individuals with limited time, as  they had been                                                               
diagnosed as terminally ill.                                                                                                    
                                                                                                                                
REPRESENTATIVE  EASTMAN  acknowledged the  conservative  approach                                                               
for  the  proposed bill,  although  he  offered his  belief  that                                                               
politics  was  driving  the  question  of  who  gets  care.    He                                                               
suggested  that many  Alaskans,  although not  expecting to  die,                                                               
could benefit from  an experimental treatment and  "may very well                                                               
die even though they weren't expecting  to."  He declared that he                                                               
"would certainly  want to see what  we could do for  those folks,                                                               
as well."  He suggested that  a more pro-active approach could be                                                               
better,  offering  as  an example  Alaska's  leadership  for  the                                                               
legalization of marijuana.                                                                                                      
                                                                                                                                
4:07:44 PM                                                                                                                    
                                                                                                                                
CHAIR SPOHNHOLZ opened public testimony.                                                                                        
                                                                                                                                
4:08:22 PM                                                                                                                    
                                                                                                                                
KEN LANDFIELD  stated his  support of HB  43, and  questioned why                                                               
this was even  an issue.  He said that  any argument for creating                                                               
a sense of false hope was not  a valid argument, as "hope is hope                                                               
and terminal  is terminal."   He declared that  the compassionate                                                               
use program was clearly not  sufficient, otherwise, 60 percent of                                                               
the state legislatures  would not have enacted a  bill similar to                                                               
HB 43.  He emphasized that  time was "absolutely of the essence."                                                               
He  offered his  support for  the proposed  bill "because,  quite                                                               
frankly, I can't think of any reason why you wouldn't."                                                                         
                                                                                                                                
4:09:38 PM                                                                                                                    
                                                                                                                                
ELIZABETH KROME, Nurse,  shared that she had been a  nurse for 38                                                               
years, working in  multiple areas, and that she  had learned that                                                               
the  removal of  hope for  a  terminal condition  was "the  worst                                                               
thing in  the world  that can  happen."   She offered  her belief                                                               
that everyone  with a  diagnosis for  a terminal  condition needs                                                               
hope  and  that individuals  need  the  option to  try  different                                                               
treatments.     She   acknowledged  the   FDA  experimental   and                                                               
investigational programs and clinical  trials, but she added that                                                               
they had very rigorous criteria.   She stated her support for the                                                               
proposed bill.   She explained  that the patient would  have many                                                               
roadblocks, which  included the need  for a physician  to support                                                               
them, to locate the drug, and  to find an insurance company which                                                               
would pay for treatment rather than deny coverage.                                                                              
                                                                                                                                
4:12:58 PM                                                                                                                    
                                                                                                                                
MIKE MAHARREY, National  Communications Director, Tenth Amendment                                                               
Center,  reported that  the Tenth  Amendment Center  had been  in                                                               
support  of this  "Right to  Try" legislation  across the  United                                                               
States,  calling  it  the  "no-brainer   issue"  because  it  was                                                               
difficult to oppose.  He  reiterated that similar legislation had                                                               
passed in  33 states.  He  stated that laws and  regulations were                                                               
supposed to protect the people,  but, by their nature, regulatory                                                               
schemes also created  bureaucracy and red tape  which could cause                                                               
harm.   He  reported that  HB 43  did not  begin to  address "the                                                               
black hole between end of  clinical trials and the final approval                                                               
of the treatment.  This process can  take up to 10 months, and it                                                               
often leaves  patients in limbo."   He offered an example  of the                                                               
benefits  to patients  from the  passage of  a similar  "Right to                                                               
Try" bill  in Texas.   He  added that  the Texas  legislature was                                                               
considering  expansion of  this bill  to include  chronically ill                                                               
patients.    He  stated  that this  legislation  illustrated  the                                                               
"beauty  of our  federated structure.   The  American system  was                                                               
never  intended  to run  based  on  one  size fits  all  solution                                                               
imposed  from Washington,  DC."   He spoke  about the  dangers of                                                               
monopoly government.   He declared that "Right to  Try" laws were                                                               
an example of states using  their rights to authority to exercise                                                               
control over  local issues.   He stated  support of  the proposed                                                               
bill.                                                                                                                           
                                                                                                                                
4:15:54 PM                                                                                                                    
                                                                                                                                
JASON NORRIS offered an example  of his father's demise from ALS,                                                               
pointing out  that it affected  the body, but  not the mind.   He                                                               
recounted an article  in the Washington Post about a  man who had                                                               
fought ALS  using advanced  therapies, which had  led to  his own                                                               
awareness of  the "Right to  Try" movement.  He  implored passage                                                               
of the proposed bill.                                                                                                           
                                                                                                                                
4:19:39 PM                                                                                                                    
                                                                                                                                
MS. IVY, in  response to an earlier  question from Representative                                                               
Tarr, offered her understanding  that federal legislation allowed                                                               
for  a quicker  path  for breakthrough  medical  devices and  had                                                               
directed  the FDA  to evaluate  the use  of real  world evidence,                                                               
observational  studies,   patient  input,  other   research,  and                                                               
clinical  trial  data  in  order   to  approve  drugs  for  other                                                               
indications, and not  simply for their initial studied  use.  She                                                               
said  that this  did not  directly impact  the compassionate  use                                                               
program, however.  She said that  there was now a requirement for                                                               
drug companies  to publish  on their  websites their  policies on                                                               
how to access investigational drugs,  which should make it easier                                                               
to find out how to access these drugs.                                                                                          
                                                                                                                                
4:21:53 PM                                                                                                                    
                                                                                                                                
MS. IVY  clarified her earlier  response to  Representative Kito,                                                               
and shared  the four main points  made by the Governor  of Hawaii                                                               
in  his veto  of similar  legislation.   These  four main  points                                                               
included  that the  compassionate  use  program already  provided                                                               
access to  investigational drugs,  although the bill  sponsor had                                                               
pointed out  that there was  a delay through this  process, which                                                               
had  resulted in  the "Right  to  Try" legislation.   The  second                                                               
point made  by the  Governor of  Hawaii was  that the  bill could                                                               
potentially  interfere with  the  overall FDA  system, and  could                                                               
result   in  the   unintended  consequence   of  delay   for  the                                                               
development  of potentially  lifesaving drugs.   She  pointed out                                                               
that  the proposed  bill did  not compete  with clinical  trials.                                                               
She relayed  that the third point  made by the governor  was that                                                               
it  violated  the  supremacy clause,  which  had  been  discussed                                                               
repeatedly during similar legislation  debate in the many states,                                                               
and had been  declared a "floor not a ceiling."   She stated that                                                               
the final  point from the governor  had been that he  was unclear                                                               
what  the actual  benefits from  the "Right  to Try"  could offer                                                               
patients.  She added that both  the Hawaiian house and senate had                                                               
unanimously passed this legislation.                                                                                            
                                                                                                                                
4:23:46 PM                                                                                                                    
                                                                                                                                
MS. IVY addressed an earlier  question from Chair Spohnholz about                                                               
the  definition  for  terminal  illness.    She  stated  that  it                                                               
appeared  the definition  used  in the  proposed  bill came  from                                                               
Louisiana and  Colorado legislation, and  had since been  used in                                                               
"Right to Try" legislation in multiple other states.                                                                            
                                                                                                                                
4:24:24 PM                                                                                                                    
                                                                                                                                
MS.  IVY  referenced  an  earlier  question  from  Representative                                                               
Johnston regarding BCG medication, which  had been developed as a                                                               
vaccine  for tuberculosis,  although it  was also  being used  to                                                               
treat bladder cancers  and melanomas.  She  referenced an earlier                                                               
speaker from  the Goldwater Institute, who  had acknowledged that                                                               
once a drug had been approved by  the FDA, then off label use was                                                               
permitted and legal.   She offered her understanding  that it was                                                               
also permitted  for a physician  to prescribe  an investigational                                                               
drug which was in Phase 2 or Phase 3 for off label use.                                                                         
                                                                                                                                
4:25:33 PM                                                                                                                    
                                                                                                                                
MS.  IVY  turned attention  to  an  earlier question  from  Chair                                                               
Spohnholz  whether  informed  consent,  as  referred  to  in  the                                                               
proposed bill,  could include a  verbal conversation  between the                                                               
doctor and  the patient.  She  said that there was  not any other                                                               
place  in  Alaska statute  where  informed  consent was  defined;                                                               
however, in  the medical community  and under medical  ethics, it                                                               
was accepted  and understood that informed  consent was different                                                               
from consent in that the patient  must understand.  She said that                                                               
whatever the form  of communication, if the  procedure, the other                                                               
options,  and the  associated risks  were fully  understood, then                                                               
Legislative  Legal Services  agreed that  the current  definition                                                               
was broad enough.                                                                                                               
                                                                                                                                
4:27:00 PM                                                                                                                    
                                                                                                                                
CHAIR SPOHNHOLZ said that HB 43 would be held over.