Legislature(2017 - 2018)CAPITOL 106
02/28/2017 03:00 PM House HEALTH & SOCIAL SERVICES
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| Audio | Topic |
|---|---|
| Start | |
| HB25 | |
| HB43 | |
| Presentation: Reducing Use of Emergency Department Services | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| *+ | HB 25 | TELECONFERENCED | |
| *+ | HB 43 | TELECONFERENCED | |
| + | TELECONFERENCED | ||
| + | TELECONFERENCED |
HB 43-NEW DRUGS FOR THE TERMINALLY ILL
3:32:40 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."
3:32:49 PM
REPRESENTATIVE JASON GRENN, Alaska State Legislature, shared
that the proposed bill was often referenced nationally as "Right
to Try" legislation. He stated that the goal of the proposed
bill was:
to create a legal climate in which terminally ill
patients who have exhausted all FDA (U.S. Food and
Drug Administration) approved treatment options may
work with their doctors and drug manufacturers to
access investigational and safe treatments that have
passed Phase I of the FDA approval process but are not
yet widely available.
REPRESENTATIVE GRENN reported that "Right to Try" laws had been
passed in 33 states, with this legislation being considered in
another 15 states, now including Alaska. Paraphrasing from the
Sponsor Statement [included in members' packets], he stated
that, each year, it was estimated that more than 1 million
Americans died from 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 a clinical trial, it is found that fewer than 3 percent are
accepted." He declared that, although the FDA did have a
program in place for accessing investigational drugs outside of
clinical trials, which was known as the "Compassionate Use
Program," it was estimated that only about 1200 people made it
through the long, arduous federal process annually. He declared
that the goal of the proposed bill was to provide the same
access as the existing program but on a shorter timeline. He
said that by assuring that terminally ill patients had more
timely access to safe, though experimental drugs, in
consultation with their doctor, the proposed bill would offer
new hope after all FDA approved options had been exhausted.
3:35:02 PM
BROOKE IVY, Staff, Representative Jason Grenn, Alaska State
Legislature, presented a PowerPoint titled "House Bill 43: The
Right to Try." She directed attention to the sectional analysis
[included in members' packets] and to slide 2, "House Bill 43."
She addressed Section 1 of the proposed bill, and stated that
this section prohibited disciplinary action by the State Medical
Board against physicians for prescribing or administering an
investigational drug to a terminally ill patient who met certain
criteria. She reported that patients had to be ineligible or
unable to participate in an ongoing clinical trial, had
considered all available treatment options in consultation with
their doctor, and had provided written consent. She moved on to
Section 2 of the proposed bill, which established that
physicians, medical team members, manufacturers, importers, and
distributors acting in good faith and with reasonable care would
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 the informed consent was obtained from the patient
and notice of immunity was also given to the patient in advance.
She added that the section also established immunity for
physicians and manufacturers who chose not to participate in the
distribution of investigational drugs. She addressed Section 3
which amended AS 17.20.110, and would allow physicians to
prescribe or administer investigational drugs under the
conditions established in Section 1 of the proposed bill. She
spoke about Section 4, which prevented the Department of Health
and Social Services from requiring a licensed health care
facility to increase its services, solely to accommodate
physicians who were prescribing or administering investigational
drugs to a patient.
3:37:37 PM
MS. IVY directed attention to slide 3, "FDA Drug Review
Process," and explained this process. She reported that, prior
to Phase 1, the sponsors of a drug were required to submit an
"Investigation New Drug" (IND) application, and through this
application, the FDA reviewed the applicant's pre-clinical
testing results, and then determined whether the drug was
reasonably safe for testing in humans.
MS. IVY spoke about slide 4, "FDA Drug Review Process (cont'd),"
and explained that in Phase 1, the studies occurring after
approval of the IND application, the studies could be conducted
on healthy volunteers dependent on the purpose of the
medication, or on individuals with specific diseases or terminal
illness. She stated that safety to determine possible side
effects and toxicity levels was the goal of Phase 1. She
addressed slide 5, "FDA Drug Review Process (cont'd)," and spoke
about the Phase 2 studies, which began when a drug was
determined to be safe, and was focused on the effectiveness of
the drug. She stated that, if there was evidence that a drug
was effective, it moved on to Phase 3, slide 6, "FDA Drug Review
Process (cont'd)." In Phase 3, more information was gained on
safety and effectiveness, particularly in varying populations
and in different dosages. After Phase 3, sponsors of the drug
have a review meeting with the FDA, and submit a new drug
application requesting approval to market the drug in the United
States, slide 7, "FDA Drug Review Process (cont'd)." After this
application, the FDA had 60 days to decide whether to file an
application for review and then applications were generally
processed within 10 months.
3:39:26 PM
MS. IVY reviewed slide 8, and explained that investigational
drugs had passed the safety testing in Phase 1, and were
currently in ongoing clinical trials in Phase 2 and Phase 3 of
the FDA process.
3:39:43 PM
MS. IVY directed attention to slide 9, "FDA's Expanded Access
Program," and spoke about the "Compassionate Use" program, which
was designed for terminally ill patients without access to
clinical trials so they could apply for these investigational
treatments. She explained that the patient had to work with
their doctor to apply directly to the FDA. She noted that,
until recently, this application took more than 100 hours for a
doctor to complete, but it had now been shortened. She
acknowledged that this was still just the first step in the
approval process. She added that manufacturers also had to
submit lengthy documentation before the application went through
the internal FDA approval process and on to a separate
institutional review board, often a lengthy multi-month process.
She reported that approximately 1200 applicants made it through
the process annually. She addressed slide 10, "The Right to Try
- A Nationwide Effort," and pointed out that this legislation
had been passed or was under consideration in all but one state.
3:41:20 PM
REPRESENTATIVE SULLIVAN-LEONARD, referencing slide 9, asked how
many applicants did not make it through the process.
MS. IVY said that she did not have that number.
REPRESENTATIVE SULLIVAN-LEONARD offered her belief that it was
an important component to the proposed bill.
3:42:05 PM
MS. IVY pointed to the Clinical Trials document [included in
members' packets] which included stories of Alaskans facing
terminal illness and the benefit of having access to the drugs.
She stated that, additionally, there was a Goldwater Institute
policy report [included in members' packets] which delved into
greater detail for the challenges of the Compassionate Use
program.
REPRESENTATIVE TARR asked for an update to the policy signed by
President Obama prior to leaving office, which had included some
provisions to expand drug trials for non-approved drugs, and for
its interaction to the proposed bill.
MS. IVY said that she would research the specifics.
3:44:18 PM
REPRESENTATIVE KITO asked why the legislation was vetoed in
Hawaii.
MS. IVY replied that, although the legislation had passed
unanimously from the legislature in Hawaii, the governor had
vetoed it. She shared that Governor Brown in California had
also vetoed the legislation, but had since changed his mind,
purportedly because of instances of benefits to patients in
Texas.
3:46:00 PM
REPRESENTATIVE KITO referenced the statement from the bill
sponsor that this was an opportunity for individuals who have
terminal illnesses to try something that was not a standard
procedure. He offered his belief that there might be
opportunities for treatment benefits prior to waiting until a
diagnosis of terminal illness. He asked why it was necessary to
wait to prescribe a potential remedy until a terminal diagnosis.
MS. IVY replied that the national advisors on this legislation
had suggested to keep a narrow focus, as this was something
already available through the FDA. She pointed out that taking
on preventative care with all medications that go through the
FDA approval process was a much larger federal policy discussion
regarding the approval of drugs in the U.S.
3:47:59 PM
CHAIR SPOHNHOLZ added that, as medications had side effects, an
important part of the FDA approval process was to ensure that
the medication was safe, did what it claimed, and its benefits
outweighed the costs. The FDA approval process was set up to
protect consumers. She offered an example of aspirin being
taken to prevent heart problems, whereas it actually increased
gastric problems as a side effect. She pointed out that
experimental drugs needed to be proven safe. She asked for the
definition of terminally ill in the proposed bill.
MS. IVY directed attention to page 2, line 12 of the proposed
bill, and she read:
"terminal illness" means a disease that, without life-
sustaining procedures, will result in death in the
near future or a state of permanent unconsciousness
from which recovery is unlikely.
3:50:43 PM
LINDA BRUCE, Attorney, Legislative Legal Counsel, Legislative
Legal Services, stated that this was a new definition which had
been drafted for this bill.
MS. IVY offered her belief that the definition came from model
legislation in other states.
3:51:32 PM
REPRESENTATIVE SULLIVAN-LEONARD asked whether the information
collected from terminally ill patients could be used for other
patients.
MS. IVY replied that the data from investigational drugs, used
outside a clinical trial, was being collected and that federal
law dictated that manufacturers needed to provide this
information to the FDA. She offered her belief that it was
required that the data be collected.
3:53:16 PM
REPRESENTATIVE TARR commented that this was Rare Diseases
Awareness Day. She shared that, as there was not a large enough
population to have statistically relevant information for
appropriate interventions, it was often a fight to get access to
medication.
3:54:50 PM
STARLEE COLEMAN, Vice President, Communications, Goldwater
Institute, reported that her organization had crafted the
language on which proposed HB 43 was based, although, she
acknowledged, there had been some Alaska specific adjustments.
She relayed that diagnosis for a terminal illness currently
offered three paths of approved options for the access to
promising investigational treatments: the first path was for
the clinical trials; the second path was for those who could
afford to travel overseas to access drugs that were already
available in countries other than the U.S; the third path was
for the connected, the aforementioned FDA "Expanded Access"
program. For the remainder of the public, there was no path to
access investigational treatments, hence the "Right to Try"
program. She stated that it was important to understand that
this program was the opposite of the right to die movement,
which was for people ready to end their own lives. The "Right
to Try" program allows patients with terminal illnesses who had
tried existing treatments with no success, and could not enroll
with a clinical trial, to access promising treatments being
safely used in government approved clinical trials. She pointed
out that it was not a question for whether or not trying an
investigational treatment was too risky, as the risk from these
treatments was exactly the same as for those entered into
government clinical trials. She emphasized that it was hard to
be selected for a clinical trial. She offered an example of
clinical trials for children diagnosed with spinal muscular
atrophy (SMA). She reported that 97 percent of cancer patients
had to rely on drugs already on the market, even if a drug in a
clinical trial was being developed specifically for their type
of cancer, and had already been approved in other countries.
She reiterated that, although about 1200 people annually made it
through the application process, it was not known how many
people were declined as FDA did not keep records. She reported
that, although the FDA declared that its approval rate was about
99 percent, she had questioned this rate. She offered an
example of a cancer trial center in Houston, the largest in the
world, which claimed that it had only been able to get one
person through the FDA "Expanded Access" process annually. She
surmised that many doctors spoke to the FDA in advance and would
not apply if the FDA stated they would not accept the
application. She pointed out the difficulty for doctors in
Alaska who were not familiar with the FDA process or hierarchy.
She compared the FDA program with a similar program in France
which treated 25,000 people annually, and declared that there
was a problem with the FDA program.
4:04:00 PM
MS. COLEMAN stated that, although no one expected a guarantee
that an investigational drug would offer a cure, they just
wanted an opportunity to try the medications already being used
in clinical trials. She declared that dying people and their
families were owed that opportunity. She stated that "Right to
Try" was already working and saving lives. She offered an
example of terminal pancreatic cancer patients. She emphasized
that states were able to do this to complement the federal drug
approval process, and not compete with it. She declared that
the right to save your own life was a human right, and that it
should not be necessary to also fight government red tape.
4:05:49 PM
REPRESENTATIVE JOHNSTON asked for clarification that the
proposed bill was for the right to try drugs that had gone
through the first, second, and third steps toward FDA approval.
MS. IVY replied that all of these drugs had passed Phase 1 for
safety testing and were currently in Phase 2 or Phase 3.
REPRESENTATIVE JOHNSTON asked if drugs allowed in Europe had
already passed Phase 1 by the FDA, and were also in Phase 2 or
Phase 3.
MS. IVY replied that was correct. She stated that in some
countries medications or treatments were in general use, and
considered safe and effective, but had not yet gone through
Phase 1 of the FDA process in order to be eligible under the
"Right to Try" program. She pointed out that a person could
travel to that country and utilize the medication, but that was
outside this process.
MS. COLEMAN offered an example for five FDA investigational
treatment drugs for breast cancer which had been approved in
other countries. She stated that "Right to Try" would allow
those treatments already in use to become available to American
women.
4:07:59 PM
CHAIR SPOHNHOLZ asked how many people had taken advantage of the
access to "Right to Try."
MS. COLEMAN replied that there was not a complete record for
that information, as there was not a state specific reporting
requirement for the use of drugs in a state with a "Right to
Try" law. She noted that this would be duplicative of drug
company reports to the FDA, adding that the FDA did not make
this information available under public records laws.
4:09:27 PM
REPRESENTATIVE JOHNSTON asked if a drug would qualify if it was
used for one treatment, even though its purpose was for
something else. She pointed out that it had already gone
through the Phase 1 safety test, but not through the next
phases.
MS. COLEMAN said that she would need more specifics about the
drug's placement in the trial process. She reiterated that the
goal of "Right to Try" was to provide access for terminal
patients to any drug which had passed the initial safety trial,
and was in on-going trials and under active investigation. She
said that it was legal for drugs to be used for another purpose,
which she termed "off label use."
4:11:28 PM
REPRESENTATIVE TARR expressed concern for the provision of
immunity, noting that medical malpractice provisions were still
in place, and asked if this had been an issue in any other
states. She asked if there was protection for an individual who
felt pressured or coerced into taking a drug.
MS. COLEMAN shared this concern that patients were protected
from any undue pressure to try something they were not fully
comfortable with and to protect them from medical malpractice.
She shared that the proposed bill had two patient protections:
(1) that a patient must voluntarily sign a comprehensive,
informed consent document, and (2) that this was totally
voluntary with no incentive for the pharmaceutical company to
participate. She said that medical malpractice laws were not
impacted by the proposed bill, and these laws would remain in
place. She declared that a point of the liability shield was to
ensure that doctors, hospitals, and pharmaceutical companies
understand that should a patient in a terminal situation die
while taking an investigational treatment, that, in and of
itself, was not a reason to be sued.
4:15:05 PM
MS. IVY added that there were other protections in the proposed
bill, as it included investigational drugs in on-going trials.
She offered her belief that, under federal law, manufacturers
cannot engage in the marketing and sale of unapproved drugs, and
were not legally permitted to sell investigational drugs for
more than the production cost. She stated that this removed the
cost benefit for manufacturers to participate.
CHAIR SPOHNHOLZ asked whether the informed consent described in
the proposed bill included a verbal discussion for the risks and
benefits.
MS. IVY, in response to Chair Spohnholz, expressed her agreement
and added that discussion would include all available treatment
options currently approved by the FDA.
CHAIR SPOHNHOLZ directed attention to page 2, lines 26 - 27, as
the guarantee of a verbal conversation with the doctor regarding
the risks and benefits of a potential treatment, and that
writing was a codification of that consent.
MS. IVY expressed her agreement that this was the intent of the
proposed bill, and expressed her support of any necessary
amendment to clarify the requirement for a verbal conversation.
4:18:24 PM
CHAIR SPOHNHOLZ said that HB 43 would be held over and public
testimony would be opened at that time.
| Document Name | Date/Time | Subjects |
|---|---|---|
| HB025 ver A 2.16.17.PDF |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Sponsor Statement 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Sectional Analysis ver A 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Supporting Document-Cost Savings Study 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Supporting Document-ADN Commentary 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Supporting Document-Guttmacher Alaska Statistics 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Supporting Document-Guttmacher Public Costs from Unintended Pregnancies 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Supporting Document-Letter Kachemak Bay Family Planning Clinic 2.23.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Supporting Document-Letter League of Women Voters Alaska 2.24.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Supporting Document-Unintended Pregnancies Study 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Supporting Document-Letter Planned Parenthood Votes Northwest & Hawaii 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Supporting Document-UCSF Study Newspaper Article 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Supporting Document-Letter Dr. Tina Tomsen 2.27.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Supporting Document-Support Emails 2.27.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Opposing Document-America's Health Insurance Plans 2.27.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Opposing Document-Letter NFIB 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Fiscal Note DHSS-Medicaid Services 2.28.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Fiscal Note DHSS-DHCS 2.28.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Fiscal Note DCCED-DIO 2.28.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB043 ver D 2.22.17.PDF |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
| HB043 Sponsor Statement 2.22.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
| HB043 Sectional Analysis ver D 2.22.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
| HB043 Supporting Document - Legislative Map 2.22.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
| HB043 Supporting Document - FDA Drug Review Process 2.22.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
| HB043 Supporting Document - Clinical Trials in Alaska.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
| HB043 Supporting Document - Goldwater Institute Fact Sheet 2.22.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
| HB043 Supporting Document - Goldwater Institute Patient Stories 2.22.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
| HB043 Supporting Document - Goldwater Institute Policy Report Summary 2.22.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
| HB43 Supporting Document - Letters of Support 2.27.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
| HB043 Fiscal Note DCCED--DCBPL 2.28.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
| HB 43 Powerpoint Presentation.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
| AK ED Coordination Project from SB 74 to H HSS.pdf |
HHSS 2/28/2017 3:00:00 PM |