Legislature(2015 - 2016)BELTZ 105 (TSBldg)
04/11/2016 01:30 PM Senate 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 | |
| SB108 | |
| SB113 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| += | SB 108 | TELECONFERENCED | |
| + | SB 113 | TELECONFERENCED | |
| *+ | SB 211 | TELECONFERENCED | |
| + | TELECONFERENCED | ||
SB 113-NEW DRUGS FOR THE TERMINALLY ILL
1:50:02 PM
CHAIR MCGUIRE announced the consideration of SB 113. [This is
the first hearing and CSSB 113(HSS) is before the committee.]
1:50:27 PM
SENATOR WIELECHOWSKI, Alaska State Legislature sponsor of SB
113, introduced the bill speaking to the following sponsor
statement:
Senate Bill 113 would create a legal climate in which
terminally ill patients who have exhausted other
available treatments and do not qualify for clinical
trials could 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 approval.
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, but not fully
approved. 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 can wait.
Since 2014, at least 44 states have seen "right to
try" legislation introduced, 12 of which still have
bills pending and 25 of which have signed bills into
law with strong, largely unanimous, bi-partisan
support. It is clear this is a human issue and one
that goes beyond state and party lines.
In providing terminal patients the ability to access
safe, but experimental drugs in consultation with a
doctor they trust, this bill offers new hope when all
FDA-approved options have been exhausted.
SENATOR WIELECHOWSKI said this bill is intended for the 97
percent of terminally ill people who apply for clinical trials
but are not accepted.
1:52:28 PM
BROOKE IVY, Staff, Senator Wielechowski Alaska State
Legislature, explained that the goal of SB 113 is to create a
legal climate so that terminally ill people can work directly
with their doctor and the drug manufacturer to access
experimental drugs that have passed phase 1 of the FDA review
process.
MS. IVY reviewed the sections of SB 113.
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.
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.
1:55:12 PM
KURT ALTMAN, Attorney, Goldwater Institute, Phoenix, Arizona,
testified in support of SB 113. He related he is the drafter of
the model legislation commonly referred to as "The Right to Try
Bill" and he has traveled across the country advocating for the
legislation. He pointed out that there are significant
protections in the bill and that this is a last chance for
terminally ill patients. For investigational medicine to be
eligible under right to try laws, it has to have passed the
safety testing phase 1 of the FDA approval process. More
importantly, the drug must be in ongoing phase 2 or phase 3
clinical trials. He confirmed that this is for the 97 percent of
terminally ill people who aren't accepted into clinical trials.
By the end of this legislative session, he expects that quite a
few more states will have passed similar legislation. This has
been a two to three year process and patients are finally taking
advantage of right to try laws, he said.
1:58:45 PM
SENATOR COGHILL asked if there have been liability issues or
families that feel somebody has been coerced into a treatment
program.
MR. ALTMAN said there has been no litigation to date with right
to try laws. For someone to receive a trial drug, there has to
be a detailed informed consent on behalf of the doctor and
patient. In practice, the manufacturers that have agreed to
provide these drugs also require a significant, detailed
informed consent liability waiver. Each law that has passed has
a similar liability waiver as SB 113 for any adverse effect from
the investigational drug. It does not waive any claims of
medical malpractice.
SENATOR COGHILL asked how the prohibition in Section 4 will
work.
2:00:53 PM
MS. IVY said the provision seeks to allay concerns of health
care facilities and hospitals about potentially losing their
certificate for Medicare or Medicaid. Other states have passed
this legislation with a similar provision. She noted that the
Department of Health and Social Services (DHSS) has determined
that SB 113 does not impact their operations due to that
provision in SB 113.
2:02:11 PM
MICHAEL MAHARREY, National Communications Director, 10th
Amendment Center, testified in support of SB 113. He said that
when the Center heard about the issue from the Goldwater
Institute, they knew they could support it without reservation.
SB 113 will take the decision-making process regarding a
patient's treatment options out of the hands of detached
individuals and put it where it belongs, with the patient and
their physician. He commented on the FDA approval process for
new drugs that is slow and cumbersome, and described right to
try laws as a bridge that spans the gap between federal
regulations and the needs of terminally ill patients. He urged
the committee to pass SB 113.
2:04:52 PM
CHARLOTTE WHITELEY, representing herself, testified in support
of SB 113. She shared a story about her father who was able to
participate in an experimental drug trial that helped him live
an extra 3 years. It was particularly important to him to know
that his data would be used to help future generations who get
multiple myeloma. She also described the case of a friend with
multiple sclerosis who participated in a drug trial in
Switzerland. A new and better drug is being developed as a
result of that trial. SB 113 allows people who are going to die
from their disease, a chance to give to the future.
2:06:35 PM
KEN LANDFIELD, representing himself, testified in support of SB
113. He said the situation is clear; the bill is designed to
provide a last ditch option for someone who is going to die
anyway. This is an opportunity for legislators to do the right
thing and it has no downside he can see. Further, it will cost
virtually nothing.
2:08:22 PM
CHAIR MCGUIRE closed public testimony on SB 113. She shared a
story about her physician father who made the decision to
develop a pilot program after the FDA denied the use of an
innovative scientific technique for his patients.
SENATOR COGHILL asked if a report goes back to the FDA to add to
the data on the experimental drug
MS. IVY said SB 113 does not include reporting requirements but
her understanding is that it is a requirement in the contracts
with manufacturers under both compassionate use and right to
try.
SENATOR COGHILL expressed satisfaction.
CHAIR MCGUIRE commented further on the pilot program her father
developed.
2:13:23 PM
SENATOR COGHILL moved to report the CS for SB 113, labeled 29-
LS0783\E, from committee with individual recommendations and
attached fiscal note(s).
2:14:04 PM
SENATOR WIELECHOWSKI said he was surprised and pleased to learn
that the Goldwater Institute supports the legislation. He
credited his staff for doing comprehensive research and
described SB 113 as good legislation that could save lives in
Alaska.
2:14:25 PM
CHAIR MCGUIRE announced that without objection, CSSB 113(HSS) is
reported from Senate Judiciary Standing Committee.