Legislature(2017 - 2018)GRUENBERG 120
03/29/2017 01:00 PM House JUDICIARY
Note: the audio ![]()
and video ![]()
recordings are distinct records and are obtained from different sources. As such there may be key differences between the two. The audio recordings are captured by our records offices as the official record of the meeting and will have more accurate timestamps. Use the icons to switch between them.
| Audio | Topic |
|---|---|
| Start | |
| HB43 | |
| HB108 | |
| HB42 | |
| HB123 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| + | HB 43 | TELECONFERENCED | |
| += | HB 108 | TELECONFERENCED | |
| + | TELECONFERENCED | ||
| += | HB 123 | TELECONFERENCED | |
| += | HB 42 | TELECONFERENCED | |
HB 43-NEW DRUGS FOR THE TERMINALLY ILL
1:02:59 PM
CHAIR CLAMAN announced that the first 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."
1:03:23 PM
REPRESENTATIVE JASON GREEN, Alaska State Legislature, read his
testimony as follows:
So, the goal of HB 43, or "Right to Try" is to create
a legal climate in which a terminally ill patient, who
has exhausted all FDA approved treatment options, may
work with their doctor and drug manufactures to access
investigational treatments that have passed Phase 1 of
the FDA approval process, but are not yet widely
available. The Right to Try laws have now been passed
in 33 states, 15 additional states, including Alaska,
are considering the law.
Each year it is estimated that over one million
Americans die from terminally ill -- terminal illness.
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 the
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 is estimated that only
about 1,200 people make it through this arduous
federal process each year.
Given this information, the goal of HB 43 is to
provide the same access as the FDA's existing
Compassionate Use Program, but on a shorter timeline.
By ensuring -- by ensuring terminally ill patients
have more timely access to safe, but experimental
drugs in consultation with their doctor, HB 43
attempts to offer new hope when all FDA approved
options have been exhausted.
1:05:31 PM
BROOKE IVY, Staff, Representative Jason Grenn, Alaska State
Legislature, paraphrased from the sectional analysis as follows
[original punctuation provided]:
Section 1: Prohibits disciplinary action of physicians
by the State Medical Board for prescribing, dispensing
or administering an investigational drug, biological
product or device to terminally ill patients that are
ineligible or unable to participate in a current
clinical trial, have considered all other treatment
options approved by the FDA and have provided written
consent.
Defines "investigational drugs, biological products
and devices" as those that have successfully completed
Phase 1 of the FDA drug review process and remain in
ongoing Phase 2 or 3 clinical trials, but have not
been approved for general use.
Defines "terminal illness" as a disease that will
result in death in the near future or permanent state
of unconsciousness from which recovery is unlikely.
Section 2: Establishes immunity for physicians,
medical team members, manufacturers and distributors
in the case of injury or death of a terminally ill
patient from the use of an investigational drug,
biological product or device, provided informed
consent was obtained from the patient and notice of
immunity was given in advance.
Establishes immunity for physicians and manufacturers
who choose not to participate in the distribution of
an investigational drug, biological product or device.
Section 3: Amends statute limiting the sale and
distribution of new drugs (AS 17.20.110) so as not to
apply to physicians prescribing or administering
investigational drugs under the conditions established
in Section 1.
Section 4: Prohibits the Department of Health and
Social Services from requiring a licensed health care
facility to increase its services solely to
accommodate physicians prescribing, dispensing or
administering investigational drugs to a patient.
1:07:42 PM
MS. IVY turned to the PowerPoint presentation titled "House Bill
43: The Right to Try," slide 3, "FDA Drug Review Process" and
advised that it is helpful to be familiar with the different
phases of the FDA drug review process. She explained that prior
to Phase 1, sponsors of a drug are required to submit the form
"Investigational New Drug Application" or IND application, and
through this application process the FDA reviews the applicant's
pre-clinical testing results and determines whether the drug is
reasonably safe for human testing. She then moved to slide 4,
"Phase 1 - Safety" wherein Phase 1 studies occur after approval
of the IND application. These studies may be conducted on
healthy volunteer when testing Ibuprofen or an anti-
inflammatory, or individuals with specific diseases or terminal
illnesses. The goal of Phase 1 testing is to determine possible
side effects and toxicity levels, wherein Phase 1 focuses on
safety.
1:08:43 PM
MS. IVY turned to slide 5, "Phase 2- Efficacy" and advised that
Phase 2 studies begin when a drug has passed Phase 1 and is
considered relatively safe, with no unaccepted toxicity level,
wherein Phase 2 focuses on the drug's effectiveness. She turned
to slide 6, "Phase 3, and advised that if there was evidence the
drug was effective, it would progress to Phase 3. During that
phase, she explained, more information would be gained regarding
safety and effectiveness, particularly, in varying populations
or different dosages in combination with other medications.
1:09:18 PM
MS. IVY turned to slide 7, "Review Meeting & New Drug
Application (NDA" and advised that after Phase 3, sponsors of
the drug participate in a review meeting with the FDA, and the
sponsors go on to complete a form titled "New Drug Application"
(NDA). In the event the drug was approved, the sponsors could
then market their drug in the United States. From that point,
the FDA has 60 days to decide whether to officially file the
application for review and, she explained, filed applications
are generally processed within 10 months of filing. She turned
to slide 8, and said that within HB 43, the term
"investigational drug" discusses those drugs that passed the
safety testing in Phase 1, and remain in ongoing clinical trials
under Phase 2 or 3 of the FDA approval process.
1:09:44 PM
MS. IVY turned to slide 9, "Compassionate Use" and noted that
the FDA has an existing Compassionate Use Program designed for
terminally ill patients who do not have access to a clinical
trial. Within this program, patients can still access those
investigational treatments outside of the clinical trial. In
order to start this process, a patient must work with their
doctor and apply to the FDA. She commented that for years, by
the FDA's own estimate, the application form alone would take an
estimated 100 hours for the doctor to complete. Although
recently, she pointed out, the FDA made great efforts to
streamline the application process, but it is only the first
step in the process. Manufacturers must submit lengthy
documentation, and once application paperwork is complete, it
must then make its way through the FDA internal approval
process, and then to a separate institutional review board for
approval, which is often a lengthy process.
1:10:59 PM
MS. IVY turned to slide 10, "The Right to Try - A Nationwide
Effort" and reiterated that 33 states signed The Right to Try
into law, and most states have had overwhelming bipartisan and
often unanimous support.
1:11:22 PM
MS. IVY referred the members to a document titled "Clinical
Trials" included in the packets, and said that HB 43 focuses on
terminally ill patients who do not qualify for clinical trials.
The sponsor included these Alaskan stories to illustrate local
experiences with terminal illness, as well as the benefit of
simply having access to new treatment options, whether in a
clinical trial or not.
CHAIR CLAMAN opened public testimony on HB 43.
1:12:40 PM
JASON NORRIS, was unavailable and Representative Grenn read Mr.
Norris's letter into the record, as follows:
I write to you today in support of HB 43, with the
short title "New Drugs for the Terminally Ill." I
understand that your time is limited and; therefore,
I'll make an effort to be as brief as possible.
In June of 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 bedridden. Eventually
it takes away their ability to breathe, at which point
they die. It should be noted that this disease does
not affect a person's mind; therefore, they are
acutely aware of their daily deterioration, and
because of this the mind becomes a prisoner within the
body. For my father, this began in June with a
reduced range of motion in his left leg. At this
point he had been working 12-hour days, 5-6 days a
week, per week as a machinist. I feel this is
important to point out because of the extended hours
and physical nature of the job. He was, by all
accounts, a very strong and healthy man at the time of
diagnosis. But, by late fall he had completely lost
his ability to walk, and at Thanksgiving he held our
5-month old son for the last time in his arms as he
became too weak to trust him with such precious cargo.
When he finally lost all movement in his limbs, he
would hug our children by nuzzling his face against
them. As we entered into the depths of winter, he and
I carried on what conversations we could, trying to
accelerate what should have been more years of passing
knowledge and wisdom from father to son. These
conversations became increasingly difficult as the
disease made his breathing quite labored, even with
the assistance of a BiPAP machine. While the painful
and emotional moments are too many to list, the most
painful came when I asked him a simple question: "Dad,
are you angry?" He responded with uncommon grace and
humility by uttering one word with every labored
breath, "I'm not angry, I'm just sad that I won't see
your kids grow up." And, in the early morning of
February 1, 2012, he died at the all too young age of
58.
My father was a good man and my hero, he was a
tireless worker, and a great role model, and an
unparalleled family man. He took a chance on Alaska
in 1996, when he moved his family from the only home
he had only known to a place that we had no
connections, no network, no family, and no friends.
The gamble paid off for all of us. He saw the
potential in this state, he fought like we all do to
make a life here, and in the end I wish the state had
afforded him the right to fight this disease with the
same ferocity.
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 advanced
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. Soon thereafter,
I became aware of the bill of which I write to you in
support of today. I implore you to pass this bill and
encourage your colleagues in the Senate to do the
same. I cannot say that these advanced therapies
would have helped save my father's life, but they may
yet save someone else's father, mother, daughter, or
son. Thank you for your consideration on this
important legislation.
1:15:56 PM
ELIZABETH KROME said she supports HB 43, has been a licensed
nurse since 1979, and practiced in a hospital setting for 30
years. Hope is one thing all humans require, she said, after
being diagnosed with a terminal condition some patients hope for
a peaceful death at home, for others their hope is to live to
see the birth of a grandchild, or a child graduating from high
school. Hope is so very important to individuals, she pointed
out, and the Right to Try allows a treatment that may or may not
prolong a life, and allows hope to continue. She said she would
love to see Alaska give individuals the right to try, and to
give them hope for the next stage of their life no matter what
it might be.
1:18:03 PM
MICHAEL MAHARREY, National Communications Director, Tenth
Amendment Center, said his organization has supported this
legislation across the United States since its beginning, and he
called it "our no brainer issue." Law and regulations are
supposed to protect people, but the regulatory scheme tends to
create bureaucracy and red tape that can cause harm. Even with
the FDA's expanded use program, it does not begin to address the
black hole between the end of clinical trials and the final
approval of treatment. This process can take up to 10 months,
leaving patients in limbo and between the end of clinical trials
and the final approval, patients do not have any alternatives.
He offered a situation wherein more than 70 Texas cancer
patients and a doctor began clinical trials when the doctor
found a successful treatment for a specific type of cancer, and
when the clinical trials were close to the end, the FDA still
hadn't given final approval for the drug. He remarked that the
FDA basically told the doctor he had to stop treating his
patients, except he was able to begin treating them under the
Right to Try new state law in Texas. Mr. Maharrey related that
Right to Try has been so successful in the State of Texas that
the Texas legislature is considering a bill to include
chronically ill patients. This type of legislation illustrates
the "beauty of our federated structure" wherein the American
system was never to run based on a one-size fits all solutions
imposed from Washington, D.C., he pointed out. In conclusion,
he said, Right to Try is a specific example of states using
their rightful authority to exercise control over local issues,
and if Right to Try helps even one Alaskan patient, it is worth
putting this legislation on the books.
1:20:43 PM
KEN LANDFIELD said he was not aware of any downside to enacting
this legislation, and the idea of creating false hope appears
disingenuous as terminal is terminal. This is an easy call and,
he pointed out, within the Constitution of the United States
there is a guarantee for the right to the pursuit of happiness
and it appears making potentially lifesaving medications
available would fall under that category, he said.
1:22:18 PM
STARLEE COLEMAN, Vice President of Communications, Goldwater
Institute, advised that the Goldwater Institute crafted the
model Right to Try law upon which this bill is based. She
offered that it is important for Alaskans to understand that the
organization reached out to doctors at major research facilities
across the country as to why they don't use the FDA's existing
Compassionate Use Program. She said that one of the best
examples of why, was from a doctor who had previously run
clinical trials for the Indy Anderson Cancer Center in Houston,
Texas, and this doctor advised that she was possibly able to get
one person each year through the FDA's expanded process. Ms.
Colman said that if only one person a year, at the largest
cancer trial center in the world, can get access to a drug
through the FDA's process, imagine what it is like for a person
in Alaska who has seen the community oncologist who has never
run a clinical trial and doesn't know who to call at the FDA.
The chances are not good that this patient would be helped
through this program because the FDA program is actually for
patients being treated at major research hospitals performing
clinical trials all the time, they know who to call and how to
navigate that system. She commented that it is not for regular
people, although it is known that Right to Try is already
working in Texas, Oregon, and Florida in accessing new treatment
options. These are real people with real families who need
help. She said she had received updated information and Right
to Try has now been adopted in 34 states due to the State of
Kentucky. She remarked that "no one who is dying expects that
an investigational treatment will cure them," but they want the
right to try and the choice to take the same medication used in
clinical trials. The Goldwater Institute believes that dying
people and their families are owed that opportunity, she said.
1:25:32 PM
CHAIR CLAMAN, after ascertaining no one wished to testify,
closed public testimony on HB 43.
1:25:42 PM
REPRESENTATIVE LEDOUX apologized for coming in late and asked
how a person is able to receive the experimental drugs.
MS. IVY responded that the FDA has a Compassionate Use Program
wherein a person can apply to for investigational drugs in
conjunction with their doctor. Currently, she explained, it is
an application process, and once the application has been turned
in, the FDA has up to 30 days to review the application and, in
the event a question comes up during the 30 day period, the 30
day clock can be reset. After that point, if the patient
receives approval from the FDA, the patient and their doctor
must seek out an external institutional review board (IRB), and
"they have no requirements" when they have to get back to the
person or approve the application. In the event the review
board only meets every six months, the patient would have to
wait for the review and approval of the request. She said that
outside of a clinical trial, that is the only way a person could
access those investigational drugs.
1:27:12 PM
REPRESENTATIVE LEDOUX noted her understanding that HB 43 would
not subject a doctor to disciplinary action, and asked how would
a person obtain the drugs and from what manufacturer.
MS. IVY explained that to be eligible, a patient must be
diagnosed as terminally ill, their doctor has exhausted all
other treatment options for whatever terminal illness they have,
and they've attempted to access a clinical trial. After all of
those steps have been taken, the person or doctor would contact
the manufacturer and request its consent to providing that
medication, outside of the clinical trial, with the
Compassionate Use Program. The person, their doctor, and the
manufacturer would all have to consent to that relationship, she
said.
1:28:36 PM
REPRESENTATIVE LEDOUX asked whether this type of legislation was
law in other states, and inquired as to how cooperative the drug
companies are to dispensing the drugs under the circumstances in
which these types of laws have been enacted.
MS. IVY responded that similar Right to Try laws have passed in
34 states, and are pending in 14 states, including Alaska. She
acknowledged that no action could be taken to force a drug
manufacturer to provide access to the medication.
Interestingly, she offered, due to a new federal law, drug
manufacturers are required to list drug on their websites to
make the drug more accessible if the drug manufacturer
participates in the Compassionate Use Program, and also lists
who to contact. She said it is becoming more accessible for
those seeking access to the Compassionate Use Program and those
seeking access outside of that program, she said.
1:29:57 PM
REPRESENTATIVE LEDOUX questioned whether any of these drugs are
available in other countries, even when they haven't been
approved by the FDA.
MS. IVY described Representative LeDoux's question as powerful
because when discussing this legislation people are thinking
about experimental drugs the nation had never seen before, but
some of the treatments going through the FDA approval process
are currently in use. For example, in Europe cancer treatments
have been in use for 15 years successfully, but those treatments
still have to go through the FDA process, which could take
anywhere from 10 - 15 years to reach approval. In the event a
treatment passes Phase 1 of the FDA process, per this
legislation, a person would be able to work with their doctor
and the manufacturer to access that treatment.
REPRESENTATIVE LEDOUX referred to drugs available in other
countries which are unavailable from the United States
manufacturers, and asked what it would take to import those
drugs as she assumed this bill doesn't do it.
MS. IVY replied that she was unsure that would be legal under
federal law, and the patient would have to travel to that
country to utilize the drug.
1:32:33 PM
EBRAHIM DELPASSAND, M.D., Excel Diagnostics & Nuclear Oncology
Center, said his specialty is Nuclear Oncology, and he is a
professor at the University of Texas, Department of Radiation
Oncology. He commented that Houston, Texas has been using Right
to Try to offer high power targeted radiation nuclear therapy
for a (indisc.) cancer, which are rare cancers in terms of other
common cancers such as, breast, prostrate, or colon cancer.
There is a special targeted therapy that was given to patients
more than 10 years ago in Europe, and his patients had to travel
to Europe to receive those treatments. In 2007, he found an
investigation for new drug applications with the FDA to offer
these treatments in Houston. He said it took him approximately
2.5 years to go through the FDA process and receive approval to
start the investigation of trial to give patients access to
these treatments. He explained that he received permission from
the drug's owner to start these trials in the United States
because, at that time, the drug was not ready to start a trial.
He said they went through all of the hoops, and finally made the
treatments available to their patients with the FDA's "sort of
approval," and in 2015, their Investigational New Drug
Application (IND) was active at his center for treatment of
these patients. Initially, he advised, he requested the
treatment for 60 patients, then increased it to 100 patients,
and then 150 patients. In February 2015, as the center was
moving closer to a 150 patient enrollment, he requested another
100 patients from the FDA because the drug was still not
commercially available. The FDA responded that it did not want
him to increase the number, not due to complaints because his
patients had good responses, the drug had a very good safety
profile, and there were many peer reviewed medical publications
on this drug from other centers, but rather because it felt that
would affect the commercialization of the drug and "This is why
you have to stop." He said he advised the FDA that
investigation of trial approval for this drug had already
completed enrollment, and actually his center was one of the
main contributors to that clinical trial so there was no way his
continuation of treating these patients would have an effect on
the commercialization of the drug. (Indisc.) to continue our
treatment while the FDA had essentially stop them from providing
these treatments to the patients. He pointed out that this is
one of the scenarios in which the Right to Try laws can help
patients receive their treatments while the FDA reviews all of
the data to approve the drug and then later commercialize. He
stressed that this is the gap in which patients will benefit
from this law in receiving their medication if it is available
to them.
1:38:25 PM
REPRESENTATIVE KOPP referred to Dr. Delpassand's testimony
regarding the FDA's decision affecting the commercialization of
the drug, and asked whether he had ever witnessed the FDA
colluding with pharmaceutical companies. Especially in the area
of expediting or delaying approvals of investigational drugs
through Phases 1-3 of clinical trials that Dr. Delpassand
believed were harmful to a patient's interest.
DR. DELPASSAND responded that the nature of the overall process
in obtaining approval has been a lengthy process, and there are
several reasons for that, such as, some clinical trials require
follow up information and the long term effect on the patient,
especially when discussing oncology and cancer. He related that
that is the nature of clinical trials because the FDA wants to
be sure the drug is safe and also effective. He explained there
are several reasons for that length of time because after a
review of considerable data, the final package is submitted to
the FDA, and thereafter, he said, it sometimes takes between 12
and 18 months until the FDA is actually able to review the
entire data and come back with its opinion as to whether it
approves or does not approve the drug. It is this period of
time wherein lies the problem, especially if the drug had
already shown effectiveness, had many publications in the
oncology community, or whatever physicians groups, and this drug
becomes common knowledge because then patients come in and ask
for the drug. The physician, knowing this drug could help their
patient, has nothing to offer because the drug had not yet been
approved and this is how Right to Try law comes into play in
certain situations. He stressed that this law does not, by any
means, provide a shortcut or cutting of corners for the FDA, or
any kind of due diligence in terms of making sure the drug is
safe and effective.
1:42:09 PM
REPRESENTATIVE FANSLER asked whether the exact bill was passed
in every state.
MS. IVY answered that most of the other versions included the
same FDA criteria, but there were different elements in each
state.
1:43:05 PM
REPRESENTATIVE FANSLER referred to a letter, in the committee
packet recommending adding amendments, and also changing the
definition of terminal illness, and he asked Ms. Ivy's response
to the letter.
MS. IVY pointed to the [3/7/17] letter from Premera, Blue Cross
Blue Shield of Alaska, and offered that the first two
suggestions were clarifying language in that a patient's health
care insurance plan was not required to cover the
investigational drugs or its possible adverse effects. She said
that coverage is not required under federal or state statute at
this time, it could be included for clarification purposes, but
it is not something the sponsor is requiring in this
legislation. Also, she noted, part of the written informed
consent form required in the bill involves a conversation
between a patient and their doctor regarding the lack of
coverage for the investigational drug, which is FDA guidance on
those informed consent forms. The third recommendation had to
do with "what they may not deny coverage for," and the sponsor's
reading was that it may add additional protections to the bill
for the patient in that, "a health insurer may not deny coverage
to a patient for pre-existing conditions, benefits that accrued
before the day in which the patient was treated with the
unapproved investigational drug or palliative care for a patient
previously treated who is no longer currently using the
investigational drug." She opined that a "majority of this" was
already mandated in the Affordable Care Act; however, it could
be something the committee could consider including if it wanted
to look down the road whether there may be changes at the
federal level. She advised that the sponsor's office spoke with
Legislative Legal and Research Services regarding this language
and it didn't indicate there were particular risks involved in
including the language. Finally, she advised, the definition
Premera, Blue Cross Blue Shield of Alaska suggested would
streamline it with Medicare's definition of terminal illness and
limit it to those who may die within the next six months. She
explained that the sponsor believes the definition is narrow in
that if a terminally ill patient was given seven months to live,
they would not be eligible to participate under the Right to Try
laws. The sponsor could not see this narrow definition, even
though the Compassionate Use Program, and he does not
necessarily support that amendment.
1:46:33 PM
REPRESENTATIVE FANSLER thanked Ms. Ivy for the map because it
depicted the almost universal acceptance of this program, and
noticed that Hawaii vetoed the legislation. He asked whether
she had any information as to the veto.
MS. IVY answered that previously, California Governor Jerry
Brown had vetoed the Right to Try law, and later the legislation
was brought forward again and Governor Brown changed his mind
based on its success stories. As far as Hawaii, Governor David
Ige, in his veto statement listed four reasons, as follows: the
Compassionate Use Program already existed and provided access;
this could interfere with the overall FDA system which may have
unintended consequences in delaying development of potentially
lifesaving drugs, of which the bill sponsor would argue that
this doesn't impact the Phases 1-3 clinical trial process; it
violated the Supremacy Clause; and, he was unclear as to the
actual benefits to the patient.
MS. IVY, in response to Representative Fansler, agreed to
provide the committee with Dr. Delpassand's written testimony.
1:49:50 PM
MS. IVY, in responded to Representative Reinbold, answered that
this bill is limited solely to the Right to Try in
pharmaceuticals.
REPRESENTATIVE REINBOLD commented that she was in pharmaceutical
sales for almost 10 years in Alaska, and in response to
Representative LeDoux's previous question, answered that within
the company she worked for, it took approximately 17 years to
move from inception to the FDA's final approval. In getting
Alaskans on clinical trials, the company had to compete with big
states because it is easier to have many patients in a
concentrated effort. She encouraged continued vetting and
related that the comment about giving "false hope" was valid.
Recently, she said, a friend was put on a clinical trial in
California, was given great hope that this would be a successful
drug for her, and it ended up that there was no result at all.
She said she appreciates the bill coming forward and that this
is an opportunity for Alaska to participate.
1:52:54 PM
REPRESENTATIVE EASTMAN commented that with the success of this
legislation in 34 states, and states trying to expand the
program to the chronically ill, asked the sponsor's perspective
on an amendment that may expand it to the chronically ill based
upon its success.
MS. IVY responded that Texas is the one state looking at
potentially expanding the definition of terminal illness to
debilitating diseases due to the law's successes. The Goldwater
Institute offered concerning regarding that concept and
preferred the initial narrow definition move forward before
looking to expand because it was a new process throughout the
different states. Additionally, she said, there is the
potential for a court challenge, and the bill sponsor is trying
to target the existing access through the Compassionate Use
Program and streamline that timing. Expanding the definition,
she pointed out, could potentially get into questions as to
whether the legislation was taking on the FDA's process on a
larger scope, and how far to expand that definition. She
offered that it is a policy call, and at this time the sponsor
would prefer to stay within the more narrow definition of
terminal illness.
1:54:56 PM
REPRESENTATIVE EASTMAN acknowledged there are several parallels
with this bill and a separate bill making its way through the
legislature in dealing with assisted suicide. Due to the bills
being similar, he asked the sponsor's thoughts as to inserting
language into the bill to make clear that is definitely not the
direction of this bill.
MS. IVY advised that it is the sponsor's position that these
bills are different as to intent because the issues are Right to
Die and Right to Try; however, the sponsor is open to
discussions regarding adding clarifying language.
1:55:52 PM
REPRESENTATIVE LEDOUX noted that she was late attending this
hearing, that some of her questions may have already been
answered, and asked the committee's indulgence. She then asked
whether there had been any organized opposition to this
legislation, or organized opposition to similar bills in other
states.
MS. IVY answered, not to her knowledge in Alaska, but nationally
there had been concern over creating false hope. Some
individuals, in response to that concern have said, "It's better
to have some hope than no hope at all." The Alaska Medical
Board and the Commission on Aging offered letters of support,
and as to the national support, she said she would defer to
Starlee Coleman at the Goldwater Institute.
1:56:47 PM
REPRESENTATIVE LEDOUX noted that either Aetna Insurance or
Premera Blue Cross Blue Shield of Alaska had suggested an
amendment, and asked the sponsor's view of that amendment.
MS. IVY pointed to the 3/7/17 letter from Premera Blue Cross
Blue Shield of Alaska that Representative Fansler had previously
inquired about, and explained that the first two suggested
amendments may be unnecessary as they are not currently
requiring insurers to cover investigational drugs under federal
or state statute. The third suggestion could add additional
protections if that was the will of the committee, but
currently, some of these are mandated by the Affordable Care
Act. She advised that in terms of narrowing the scope of the
definition of terminal illness, the sponsor does not support
that suggestion.
[HB 43 was held over.]