02/28/2018 01:30 PM Senate JUDICIARY
| Audio | Topic |
|---|---|
| Start | |
| SB173 | |
| HB43 | |
| Adjourn |
+ teleconferenced
= bill was previously heard/scheduled
| + | SB 173 | TELECONFERENCED | |
| + | HB 43 | TELECONFERENCED | |
| + | TELECONFERENCED |
ALASKA STATE LEGISLATURE
SENATE JUDICIARY STANDING COMMITTEE
February 28, 2018
1:46 p.m.
MEMBERS PRESENT
Senator John Coghill, Chair
Senator Mia Costello
Senator Pete Kelly
Senator Bill Wielechowski
Senator Click Bishop
MEMBERS ABSENT
All members present
COMMITTEE CALENDAR
SENATE BILL NO. 173
"An Act relating to the liability of a person or the state for
the release of certain pesticides during application on a
utility pole."
- HEARD & HELD
COMMITTEE SUBSTITUTE FOR HOUSE BILL NO. 43(JUD)
"An Act relating to prescribing, dispensing, and administering
an investigational drug, biological product, or device by
physicians for patients who are terminally ill for the purpose
of sustaining the patient's life; providing immunity related to
manufacturing, distributing, or providing investigational drugs,
biological products, or devices; and relating to licensed health
care facility requirements."
- HEARD & HELD
PREVIOUS COMMITTEE ACTION
BILL: SB 173
SHORT TITLE: LIABILITY: PESTICIDES & UTILITY POLES
SPONSOR(s): SENATOR(s) MICCICHE
02/02/18 (S) READ THE FIRST TIME - REFERRALS
02/02/18 (S) RES
02/12/18 (S) RES AT 3:30 PM BUTROVICH 205
02/12/18 (S) Heard & Held
02/12/18 (S) MINUTE(RES)
02/14/18 (S) RES AT 3:30 PM BUTROVICH 205
02/14/18 (S) Heard & Held
02/14/18 (S) MINUTE(RES)
02/16/18 (S) RES AT 3:30 PM BUTROVICH 205
02/16/18 (S) Moved CSSB 173(RES) Out of Committee
02/16/18 (S) MINUTE(RES)
02/19/18 (S) RES RPT CS 2DP 3NR NEW TITLE
02/19/18 (S) DP: GIESSEL, COGHILL
02/19/18 (S) NR: BISHOP, VON IMHOF, MEYER
02/19/18 (S) JUD REFERRAL ADDED AFTER RES
02/28/18 (S) JUD AT 1:30 PM BELTZ 105 (TSBldg)
BILL: HB 43
SHORT TITLE: NEW DRUGS FOR THE TERMINALLY ILL
SPONSOR(s): REPRESENTATIVE(s) GRENN
01/18/17 (H) PREFILE RELEASED 1/13/17
01/18/17 (H) READ THE FIRST TIME - REFERRALS
01/18/17 (H) HSS, JUD
02/28/17 (H) HSS AT 3:00 PM CAPITOL 106
02/28/17 (H) Heard & Held
02/28/17 (H) MINUTE(HSS)
03/02/17 (H) HSS AT 3:00 PM CAPITOL 106
03/02/17 (H) Heard & Held
03/02/17 (H) MINUTE(HSS)
03/07/17 (H) HSS AT 3:00 PM CAPITOL 106
03/07/17 (H) Moved HB 43 Out of Committee
03/07/17 (H) MINUTE(HSS)
03/08/17 (H) HSS RPT 5DP 1NR 1AM
03/08/17 (H) DP: JOHNSTON, TARR, EDGMON, SULLIVAN-
LEONARD, SPOHNHOLZ
03/08/17 (H) NR: KITO
03/08/17 (H) AM: EASTMAN
03/29/17 (H) JUD AT 1:00 PM GRUENBERG 120
03/29/17 (H) Heard & Held
03/29/17 (H) MINUTE(JUD)
04/03/17 (H) JUD AT 1:00 PM GRUENBERG 120
04/03/17 (H) Moved CSHB 43(JUD) Out of Committee
04/03/17 (H) MINUTE(JUD)
04/05/17 (H) JUD RPT CS(JUD) NT 5DP 1NR
04/05/17 (H) DP: EASTMAN, KOPP, FANSLER, LEDOUX,
CLAMAN
04/05/17 (H) NR: REINBOLD
04/10/17 (H) MOVED TO BOTTOM OF CALENDAR
04/10/17 (H) MOVED TO BOTTOM OF CALENDAR
04/10/17 (H) TRANSMITTED TO (S)
04/10/17 (H) VERSION: CSHB 43(JUD)
04/11/17 (S) READ THE FIRST TIME - REFERRALS
04/11/17 (S) HSS, JUD
01/24/18 (S) HSS AT 1:30 PM BUTROVICH 205
01/24/18 (S) Heard & Held
01/24/18 (S) MINUTE(HSS)
01/29/18 (S) HSS AT 1:30 PM BUTROVICH 205
01/29/18 (S) Moved CSHB 43(JUD) Out of Committee
01/29/18 (S) MINUTE(HSS)
01/31/18 (S) HSS RPT 3DP 1NR
01/31/18 (S) DP: VON IMHOF, BEGICH, GIESSEL
01/31/18 (S) NR: MICCICHE
02/28/18 (S) JUD AT 1:30 PM BELTZ 105 (TSBldg)
WITNESS REGISTER
SENATOR PETER MICCICHE
Alaska State Legislature
Juneau, Alaska
POSITION STATEMENT: Sponsor of SB 173.
DAVID WILKINSON, Assistant Attorney General
Civil Division
Environmental Section
Department of Law
Anchorage, Alaska
POSITION STATEMENT: Answered questions related to SB 173.
EMILY NAUMAN, Legislative Counsel
Legislative Legal Services
Alaska State Legislature
Juneau, Alaska
POSITION STATEMENT: Answered questions related to SB 173.
KRISTIN RYAN, Director
Spill Prevention and Response
Department of Environmental Conservation (DEC)
Anchorage, Alaska
POSITION STATEMENT: Answered questions related to SB 173.
ERIC FJELSTAD, Attorney
Perkins Coie LLP
Anchorage, Alaska
POSITION STATEMENT: Testified in support of SB 173 on behalf of
the Homer Electric Association.
MICHAEL ROVITO, Director of Member and Public Relations
Alaska Power Association
Anchorage, Alaska
POSITION STATEMENT: Testified in support of the CS for SB 173.
REPRESENTATIVE JASON GRENN
Alaska State Legislature
Juneau, Alaska
POSITION STATEMENT: Sponsor of HB 43
BROOKE IVY, Staff
Representative Jason Grenn
Alaska State Legislature
Juneau, Alaska
POSITION STATEMENT: Delivered a sectional analysis for HB 43 and
answered related questions.
ACTION NARRATIVE
1:46:33 PM
CHAIR JOHN COGHILL called the Senate Judiciary Standing
Committee meeting to order at 1:46 p.m. Present at the call to
order were Senators Costello, Wielechowski, Kelly and Chair
Coghill. Senator Bishop arrived during the introduction.
SB 173-LIABILITY: PESTICIDES & UTILITY POLES
1:47:14 PM
CHAIR COGHILL announced the consideration of SB 173. He listed
the individuals available to answer questions.
1:48:09 PM
SENATOR MICCICHE, Alaska State Legislature, Juneau, Alaska,
sponsor of SB 173, said he introduced the legislation after an
employee from the Kenai National Wildlife Refuge did an
unscientific sampling and found residue of pentachlorophenol
("penta") around a power pole. The compound is used as an
insecticide to extend the life of these poles. Utility companies
worried that if they were asked to completely remove all 250,000
utility poles in the state, their potential exposure would be
about $7.5 billion. He continued the introduction speaking to
the following sponsor statement:
The bottom-line purpose of my choice to bring SB173
forward is the financial protection of nearly every
Alaskan ratepayer who depends upon a utility to
deliver electricity to their home, business or
facility. SB173 conforms Alaska law to federal law
with respect to wood poles treated with pesticides
registered with the Environmental Protection Agency.
The legislation is drafted narrowly to apply only to a
"wood utility pole installed, removed or used by
public utilities in connection with providing a
utility service in the state."
In the State of Alaska, every wooden utility pole is
factory-treated with a preservative/pesticide which
prolongs the service life of the pole by protecting it
from organisms that compromise structural integrity.
It is logical to assume that soil coming in direct
contact with treated utility poles for 30 or more
years would include traces of that preservative.
The provisions of AS 46.03.822(a) are interpreted to
assume public utility liability and indirectly,
Alaskan ratepayers for remediating residual
preservative when replacing or removing treated wooden
utility poles. This liability does not exist under
federal law because the companion federal statute to
AS 46.03.822 contains a specific exemption for "the
application of a pesticide product registered under
the Federal Insecticide, Fungicide, and Rodenticide
Act [7 U.S.C. 136 et seq.]."
SB 173 clarifies and eliminates the assumption of
liability and remediation costs for trace elements by
including the federal exemption within Alaska's
statutes.
SENATOR MICCICHE said the expectation is that the Department of
Environmental Conservation (DEC) will provide best practice
guidelines for use requirements and disposal of preservative-
treated utility poles to control or eliminate future
contamination when poles are retired.
He expressed appreciation that the committee requested the
additional referral because it's important that the liability
matches that under the federal code. There is no desire to
account for liability beyond that point.
1:51:13 PM
SENATOR WIELECHOWSKI asked what provision in FIFRA exempts the
federal government from liability.
SENATOR MICCICHE deferred the question to DEC or the legislative
drafter, Emily Nauman.
1:52:23 PM
SENATOR COSTELLO asked if SB 173 takes the same approach that
other states facing this issue have taken.
1:54:20 PM
DAVID WILKINSON, Assistant Attorney General, Civil Division,
Environmental Section, Department of Law, Anchorage, Alaska,
advised that the exemption under federal law is found in
Comprehensive Environmental Response, Compensation, and
Liability Act (CERCLA) Section 107 (i) [42 U.S.C. 9607(i)]. That
exemption applies to registered pesticides broadly, not utility
poles specifically. It exempts the application of a pesticide
that has been registered under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) from liability under
CERCLA. The provision includes savings language that provides
that it does not affect or modify other statutory or common law
obligations.
SENATOR WIELECHOWSKI read the first sentence of 42 U.S.C.
9607(i) into the record:
(i) Application of a registered pesticide product
No person (including the United States or any State or
Indian tribe) may recover under the authority of this
section for any response costs or damages resulting
from the application of a pesticide product registered
under the Federal Insecticide, Fungicide, and
Rodenticide Act [7 U.S.C. 136 et seq.]. [Nothing in
this paragraph shall affect or modify in any way the
obligations or liability of any person under any other
provision of State or Federal law, including common
law, for damages, injury, or loss resulting from a
release of any hazardous substance or for removal or
remedial action or the costs of removal or remedial
action of such hazardous substance.]
He said his staff found that courts have interpreted that as the
actual application of the pesticide on poles or somewhere else.
He asked Mr. Wilkinson if he had a different understanding of
the courts' interpretation.
MR. WILKINSON said no. The focus is on the application, which is
the intended use of a pesticide. The way federal case law has
played out is if the pesticide is intended to be sprayed on one
plant and it drifts onto a nearby property, that drift is not
the application of the pesticide that is shielded under CIRCLA.
Only the intended use of the pesticide is shielded.
SENATOR WIELECHOWSKI read the second sentence of 42 U.S.C.
9607(i) into the record:
Nothing in this paragraph shall affect or modify in
any way the obligations or liability of any person
under any other provision of State or Federal law,
including common law, for damages, injury, or loss
resulting from a release of any hazardous substance or
for removal or remedial action or the costs of removal
or remedial action of such hazardous substance.
He said his understanding is that the federal law only provides
an exemption for the actual application of the pesticide, but it
doesn't shield the product from any laws states or the federal
government have adopted in that regard. He asked if it's fair to
say that Alaska is not out of compliance.
MR. WILKINSON said he agreed with that reading of the provision.
CHAIR COGHILL said the bill is before the committee to make that
determination.
SENATOR COSTELLO asked Ms. Nauman if this legislation was based
on model law.
1:59:27 PM
EMILY NAUMAN, Legislative Counsel, Legislative Legal Services,
Alaska State Legislature, Juneau, Alaska, said she was not aware
of that, but she would look into it.
CHAIR COGHILL requested she send her response to both his office
and the sponsor's.
SENATOR WIELECHOWSKI read AS 09.65.085(a) and opined that it
gives utility companies the liability exemption they're looking
for. He asked if she or Mr. Wilkinson have a different
interpretation.
MR. WILKINSON said he would need to do additional research
before he answered.
2:01:49 PM
SENATOR MICCICHE clarified that application is not spraying the
pesticide. "The application is the use of the pesticide so
there's a little misunderstanding there." He restated that he
introduced SB 173 because he doesn't want there to be a need for
a cleanup of the 250,000 poles in the state if they have residue
of penta around the poles for a reasonable distance. There is no
intent to entirely absolve liability. The intent is to find the
right mix of liability that protects the normal, intended use
and application of penta.
CHAIR COGHILL asked Senator Wielechowski to restate his question
for Ms. Nauman.
SENATOR WIELECHOWSKI said he doesn't believe that current state
law is at odds with the federal law 42 U.S.C. 4607(i) regarding
the application of registered pesticides. The exemption under
CERCLA applies to the application of pesticides that are
registered under FIFRA. The second sentence of 42 U.S.C. 4607(i)
specifically gives states and the federal government the right
to enact whatever laws they wish on this topic.
2:04:51 PM
MS. NAUMAN said she would need to examine CERCLA more closely
before giving a response.
CHAIR COGHILL asked what remedy would be available if the bill
passes and people had trouble with penta residue on their
property.
2:05:46 PM
MR. WILKINSON said other remedies are likely to survive
exemption to AS 46.03.822 with two caveats, but it isn't clear
how an exemption to .822 would alter those common law remedies.
Also, common law remedies are not direct substitutes for AS
46.03.822. Some federal district courts have held that CERCLA
preempts federal common law causes of action that are subsumed
under the structure of CERCLA. However, in the pesticide context
the FIFRA exemption in CERCLA section 107(i) expressly preserves
those other statutory rights in common law, causative action.
He said he hasn't found similar case law in Alaska looking at
the impact of .822 on common law claims. The Alaska Supreme
Court has analyzed common law causes of action, which is
negligence, nuisance, and trespass alongside .822 causes of
action but hasn't squarely addressed whether .822 preempts those
common law claims. There is a question there and about the
interplay between a statute and common law in these more
traditional claims.
One example of this interplay is in the negligence context.
Negligence cause of action, which would arguably survive for a
landowner, requires duty, breach of duty, causation, and harm.
But when courts look to find a duty, they look to statutes so
there's a question raised by an exemption to .822. Does that
alter the duty that a utility company might owe a landowner?
They're exempt from liability for release of hazardous
substances under a statute. Whether that changes the duty that
they have to landowners is potentially a litigation question.
CHAIR COGHILL commented that the clearer we can speak in this
statute, the better for common law remedies.
MR. WILKINSON agreed that clarity in the statute would lessen
the argument that an exemption changes the common law somehow.
CHAIR COGHILL asked Ms. Ryan who a private individual would go
to if they found pollution on their property that contaminated
their well.
2:10:23 PM
KRISTIN RYAN, Director, Spill Prevention and Response,
Department of Environmental Conservation (DEC), Anchorage,
Alaska, said Mr. Wilkinson expressed that there are some
unknowns as to how a court would interpret liability in that
scenario. DEC would eliminate the exposure pathway by providing
a drinking water source if the chemicals were carcinogenic when
consumed but deciding who would pay for that or who would remedy
the problem is a little murky. Based on the language, she
guessed that the utility company would not be liable, and the
homeowner probably would not be liable. It is clear that the
state would be obliged to use its resources to remedy the
problem.
CHAIR COGHILL asked if there has ever been a problem in Alaska.
MS. RYAN said not that she was aware of.
CHAIR COGHILL asked if she had experience with any of these
common law remedies.
MS. RYAN said joint and several liability statutes are very
clear that all the parties that spilled the contaminant are
responsible, as well as the land owner who inherited the
contaminated property. She was not aware of any broad
exemptions; this would be the first.
CHAIR COGHILL asked if contamination of groundwater [from
residue around a power pole] was likely or highly speculative.
MS. RYAN said contamination of a private drinking water well
from utility pole residue has not occurred in Alaska, but she
was aware of it happening in one other state. The chance of this
occurring is remote, but the question is what would occur if it
did happen. DEC is working with industry to develop best
management practices to minimize any migration of chemicals from
the utility poles into an aquifer. DEC's focus has always been
to be proactive instead of dealing with the problem after the
fact.
2:16:26 PM
CHAIR COGHILL asked if DEC defines minimal standards for other
contaminants instead of a blanket exemption.
MS. RYAN said she was unaware of any exemptions in the liability
statutes, but the department believes that a minimal amount of
leaching around a utility pole is to be expected and would not
be a large concern. She suggested that if that was the utility
companies' concern, it should be clearly stated in the
legislation. That would provide the companies some relief and
wouldn't tie the department's hands to deal with a significant
contamination event.
2:18:03 PM
SENATOR WIELECHOWSKI summarized that the bill exempts both the
utility company and the homeowner from liability. He asked if
she interprets the language in Section 1 regarding liability of
persons to include the state.
MS. RYAN agreed with the summary and that the Department of
Labor and Workforce Development (DOLWD) would meet the
definition in Section 1. She added that even though liability
would not fall to DOT, DEC would need to utilize some funds to
eliminate the exposure pathway so that human health isn't
impacted.
SENATOR WIELECHOWSKI said he didn't want utility companies to
replace 250,000 poles but somebody must be responsible if there
is significant contamination. He asked her to think about an
amendment he was working on that adds a paragraph under
subsection (b) in Section 1. It basically says, "there is no
liability as long as the release does not contaminate soil,
surface water or ground water beyond the radius depth and
concentration specified by the Department of Environmental
Conservation." The amendment goes on to determine by regulation
what radius depth and concentration would potentially lead to
the harm of public safety or welfare.
CHAIR COGHILL asked if contamination is measured in parts per
million or if each pesticide is considered based on the latest
health bulletin.
MS. RYAN replied DEC relies on the numbers in regulation
regarding what is safe for dioxins in different receiving
environments and human health. She also pointed out that while
penta is approved for use on utility poles, it is not the main
chemical of concern for leaching. It is dioxin, which is a
byproduct of the manufacturing process. The EPA talks at great
length about that in the record of decisions approving its use
in these situations.
CHAIR COGHILL asked if she had any comment on Senator
Wielechowski's proposed amendment.
MS. RYAN replied the department has been considering a similar
improvement to the legislation. Setting a minimal level of
contamination as acceptable would require the department to be
very specific in its regulations, but before they could be
drafted more information is needed to understand where the
chemicals are migrating and how far.
2:23:57 PM
SENATOR WIELECHOWSKI asked if a homeowner would be required to
disclose when they sold their property that utility poles in the
right-of-way on their property were leaching pesticides or
dioxins.
MS. RYAN said a homeowner would be required to disclose that
information if they were aware of it, but she would assume most
homeowners would not have that information.
CHAIR COGHILL said he'd like to hear from utility companies at
this point.
2:25:41 PM
ERIC FJELSTAD, Attorney, Perkins Coie LLP, Anchorage, Alaska,
said he was testifying in support of SB 173 on behalf of the
Homer Electric Association. He said he would offer the utility
company's perspective on the issues that have been raised
focusing on the state liability scheme under AS 46.03.822 and
comparing it to the federal liability scheme under the
Comprehensive Environmental Response, Compensation, and
Liability Act (CERCLA). He said he agrees with Senator
Wielechowski that this isn't a question of the state being out
of compliance with federal law. The question is what the state
should do as a matter of policy because it does have latitude.
Section 107 (i) of CERCLA says that if a pesticide has been
registered and approved by EPA, then CERCLA cannot be used to
require an investigation and cleanup of that pesticide. Similar
provisions in CERCLA apply to other situations such as federal
air or water permits and consumer product exception for
asbestos. The policy issue is that while these products may be
harmful, when they are used properly Congress through CERCLA
should not create a liability scheme where something is used
pursuant to its intended use. AS 46.03.822 is modeled on CERCLA
and proposes to include pesticides in the state liability
scheme.
MR. FJELSTAD said he was highly confident that these pesticides
would fall within the exemption under CERCLA because the
exemption in federal law is being actively regulated by another
federal scheme. It's not just Congress making an exemption that
some particular person or industry shouldn't be liable. This
goes to Senator Coghill's question about whether this has been a
problem in the past. It hasn't been a problem because the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is
actively regulating how these materials can be applied in
practice.
He explained that the utility companies are concerned because
the question about pesticide leaching was raised in the one
instance and there is an affirmative obligation for any party
that is aware of a release to report it to DEC and that starts
the cleanup process. There are hundreds of thousands of poles in
the state and the question is whether the utility companies must
go out and prove a negative, that there is nothing there or that
it's de minimis.
2:31:01 PM
CHAIR COGHILL asked if the general liability in existing statute
would apply in this situation.
MR. FJELSTAD said he would like to say it applies but he would
be nervous doing so given that the courts generally construe
exceptions to liability narrowly.
SENATOR WIELECHOWSKI asked what liabilities would be available
to homeowners or affected individuals if the bill were to pass
as currently drafted.
MR. WILKINSON said common law exceptions are likely to survive,
but the Alaska Supreme Court has not directly addressed the
question of whether AS 46.03.822 has an impact on the survival
of common law claims. Chapter 46.03 does have the regulation of
hazardous substances including the prohibition of releasing
hazardous substances without a permit and prohibitions on
pollution.
SENATOR COSTELLO asked if there is higher liability regarding
utility easements near school grounds.
MR. WILKINSON said AS 46.03.822 doesn't change the liability
based on the vulnerability of people who might be injured.
CHAIR COGHILL commented that it's an interesting question when
school yards are often paved with asphalt.
2:37:55 PM
MICHAEL ROVITO, Director of Member and Public Relations, Alaska
Power Association, Anchorage, Alaska, stated support for the CS
for SB 173. He said large and small utility companies throughout
Alaska utilize the pesticide pentachlorophenol on the hundreds
of thousands of utility poles they own throughout the state. Use
of this pesticide is regulated under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). In 2008, the U.S.
Environmental Protection Agency reregistered penta after issuing
a report that found the benefits of penta outweighed any
remaining risks. The FIFRA regulations ensure that using the
pesticide according to specification will not cause unreasonable
adverse effects on the environment. SB 173 ensures that the
pesticide on utility poles is properly regulated as pesticide
use and not spills. This is an important distinction missing in
Alaska law. The bill also provides that the use of penta on
utility poles will be regulated under Alaska's pesticide control
program under FIFRA instead of under DEC's Division of Spill
Prevention and Response.
2:40:40 PM
CHAIR COGHILL said he intended to look into Alaska's pesticide
control program under FIFRA.
2:41:45 PM
SENATOR MICCICHE said his office has worked with DEC throughout
this process to find the right balance on liability. This is
about protection of Alaska ratepayers.
SENATOR BISHOP said he doubts there would be a spill from these
poles, but there could be an inadvertent release.
SENATOR MICCICHE said there have only been two incidents in the
history of the use of penta and he assumes that the penta was
improperly applied during manufacture.
CHAIR COGHILL commented that even that would be identified as
leaching, not a spill.
SENATOR BISHOP added that Kristen Ryan has a calculation for
what is a reportable spill and what is not.
SENATOR MICCICHE reiterated that he wanted to get the right
balance.
2:45:21 PM
CHAIR COGHILL held SB 173 in committee.
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.
2:57:46 PM
There being no further business to come before the committee,
Chair Coghill adjourned the Senate Judiciary Standing Committee
meeting at 2:57 p.m.