Legislature(2017 - 2018)BELTZ 105 (TSBldg)
02/28/2018 01:30 PM Senate JUDICIARY
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| Audio | Topic |
|---|---|
| Start | |
| SB173 | |
| HB43 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| + | SB 173 | TELECONFERENCED | |
| + | HB 43 | TELECONFERENCED | |
| + | TELECONFERENCED |
HB 43-NEW DRUGS FOR THE TERMINALLY ILL
2:45:36 PM
CHAIR COGHILL announced the consideration of HB 43.
2:46:15 PM
REPRESENTATIVE JASON GRENN, Alaska State Legislature Juneau,
Alaska, sponsor of HB 43, introduced the legislation speaking to
the following sponsor statement:
House Bill 43 would allow terminally ill patients who
have exhausted other available treatments and do not
qualify for clinical trials to gain faster access to
safe, but experimental drugs in an effort to save
their own lives. By providing certain immunities to
prescribing physicians, manufacturers and distributors
acting in good faith, this bill would allow terminal
patients, in consultation with their doctor, the
freedom to try new treatments as they fight to
survive, without the burden of waiting for federal
approval.
More than 1 million Americans die from a terminal
illness every year. Many spend years searching for a
potential cure, or struggle in vain to get accepted
into a clinical trial. Unfortunately, FDA red tape and
government regulations can often restrict access to
promising new treatments, and sometimes for those who
do get access, it is too late.
The United States Food and Drug Administration
currently offers an "expanded access" or
"compassionate use" exemption that allows terminally
ill patients that meet certain criteria to access
drugs in the clinical trial phase. However, even with
recent efforts by the FDA to streamline the
application process, this exemption program is known
to be arduous and can take longer than patients facing
terminal illness have to wait.
Since 2014, 38 states have signed "right to try"
legislation into law with strong, bi-partisan support.
It is clear this is a human issue that goes beyond
state and party lines, and could provide Alaskans
increased access to potentially life-saving treatments
in the times they need it most.
In allowing Alaskans facing terminal illness the
ability to access safe, though experimental drugs in
consultation with a doctor they trust, this bill
offers new hope when all FDA-approved options have
been exhausted. I urge your support of House Bill 43.
REPRESENTATIVE GRENN read a letter of support from a
constituent.
I write to you today in support of HB 43 with the
short title, "New Drugs for the Terminally Ill." In
June 2011, my father was diagnosed with ALS, sometimes
known as Lou Gehrig's disease. For those unfamiliar,
this disease slowly saps a person's ability to move,
rendering them bed-ridden. Eventually it takes away
their ability to breathe at which point they die. For
my father, this deterioration began in June.
He had been working 12 hours days, five or six days a
week as a machinist. He was, by all accounts, a very
strong and health man at the time of his diagnosis. By
late fall he had completely lost his ability to walk.
At Thanksgiving, he held out five-month-old son for
the last time in his arms as he had become to weak to
be trusted with such precious cargo. In early morning
of February 1, 2012, he died at the all too young age
of 58.
In the end I wish the State had afforded him the right
to fight his disease. Recently in the Washington Post
there was an article detailing the experience of a man
who had, for all intents and purposes, beaten ALS
through advance therapies pioneered by doctors at the
ALS Center in Atlanta, Georgia. In reading about this
man, I became aware of the Right to Try movement. I
cannot say for sure that these advance therapies may
have saved my father's life, but they may yet same
someone's father, mother, daughter, or son.
Thank you for your consideration on this important
legislation.
REPRESENTATIVE GRENN stated that the goal of HB 43 is to provide
the same access as the FDA's Compassionate Use Program, but on a
shorter timeline. That program recognizes that 97 percent of
people are not accepted in clinical trials. HB 43 seeks to offer
new hope when all other FDA approved options have been
exhausted.
2:50:15 PM
BROOKE IVY, Staff, Representative Jason Grenn, Alaska State
Legislature Juneau, Alaska, paraphrased the following sectional
analysis for HB 43:
Section 1: Prohibits disciplinary action of physicians
by the State Medical Board for prescribing, dispensing
or administering an investigational drug, biological
product or device to terminally ill patients that are
ineligible or unable to participate in a current
clinical trial, have considered all other treatment
options approved by the FDA and have provided written
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 or the marketing
application process but have not been approved for
general use.
Defines "terminal illness" as a disease that will
result in death in the near future or permanent state
of unconsciousness from which recovery is unlikely.
Section 2: Establishes immunity for physicians,
medical team members, manufacturers and distributors
in the case of injury or death of a terminally ill
patient from the use of an investigational drug,
biological product or device, provided informed
consent was obtained from the patient and notice of
immunity was given in advance.
Establishes immunity for physicians and manufacturers
who choose not to participate in the distribution of
an investigational drug, biological product or device.
Section 3: Amends statute limiting the sale and
distribution of new drugs (AS 17.20.110) so as not to
apply to physicians prescribing or administering
investigational drugs under the conditions established
in Section 1.
Section 4: Prohibits the Department of Health and
Social Services from requiring a licensed health care
facility to increase its services solely to
accommodate physicians prescribing, dispensing or
administering investigational drugs to a patient.
CHAIR COGHILL asked if 97 percent of Alaskans have been denied
clinical trials.
MS. IVY replied that is a national number. She noted the
clinical trials document in the packet has stories of Alaskans
who have been admitted into clinical trials.
CHAIR COGHILL asked her to discuss the FDA drug review process.
MS. IVY explained that when a drug manufacturer's application
for an investigational new drug (IND) is accepted, the drug
moves into phase 1. The drug is studied for possible side
effects and toxicity levels on healthy volunteers. Phase 2 looks
at how effective the drug is for the condition. Phase 3 looks at
safety again as well as effectiveness.
CHAIR COGHILL asked if the informed consent form tells an
individual they are part of a trial.
2:55:22 PM
MS. IVY clarified that the volunteer would not be in a clinical
trial, but the data related to the experimental drug would be
collected and sent to the FDA.
2:57:32 PM
CHAIR COGHILL held HB 43 in committee.