Legislature(2017 - 2018)BUTROVICH 205
01/24/2018 01:30 PM Senate HEALTH & SOCIAL SERVICES
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| Audio | Topic |
|---|---|
| Start | |
| HB43 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| + | HB 43 | TELECONFERENCED | |
HB 43-NEW DRUGS FOR THE TERMINALLY ILL
1:31:09 PM
CHAIR WILSON announced the consideration of HB 43 with his
intent to hear and hold the bill. [CSHB 43(JUD), version 30-
LS0207\J, was before the committee.]
1:31:31 PM
REPRESENTATIVE JASON GRENN, Alaska State Legislature, sponsor of
HB 43, paraphrased the first paragraph of his 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.
REPRESENTATIVE GRENN noted that since 2014, 38 states have
signed similar legislation into law with strong bipartisan
support. HB 43 is supported by the Alaska State Medical Board,
the Alaska Commission on Aging, individual providers, and
countless Alaskans. Last session the bill passed the House 40-0.
He said more than 1 million Americans die from a terminal
illness every year. Fewer than three percent of patients who try
to be become part of a clinical trial are accepted. The United
States Food and Drug Administration (FDA) has a compassionate
care process to allow patients to access experimental drugs.
Nationally, estimates are that only 1,200 people make it through
this federal process. HB 43 provides the same access the FDA
program gives, but on a shorter timeline.
He said HB 43 is similar to the FDA compassionate care program,
but on a shorter timeline. "HB 43 attempts to offer new hope
when all other FDA-approved options have been exhausted," he
said.
1:34:15 PM
REPRESENTATIVE GRENN read from a letter of support from a man
whose father died of ALS, often known as Lou Gehrig's disease,
at the age of 58. The man wished his father had had options to
try other treatments.
1:35:33 PM
BROOKE IVY, Staff, Representative Grenn, Alaska State
Legislature, provided an overview of HB 43 paraphrasing the
following sectional analysis:
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.
1:37:55 PM
MS. IVY reviewed the FDA's Drug Review Process. Prior to Phase
One, sponsors of a drug submit an Investigational New Drug (IND)
Application.
1:38:32 PM
MS. IVY said the FDA then reviews preclinical testing results to
determine whether the drug is reasonably safe for testing in
humans. Phase One studies occur after the approval of the IND
application. The goal of Phase One testing is to determine
possible side effects and toxicity levels.
1:39:09 PM
MS. IVY said drugs that pass Phase One are considered relatively
safe and Phase Two focuses on a drug's effectiveness.
1:39:26 PM
MS. IVY said drugs considered effective pass onto to Phase
Three, where more information is gained on safety and
effectiveness, particularly with varying populations and in
combination with other drugs.
1:39:38 PM
MS. IVY said that after Phase Three, sponsors have a drug review
meeting with the FDA and complete a New Drug Application (NDA).
If approved the drug can be marketed in the United States.
1:40:00 PM
SENATOR VON IMHOF asked how long each phase is and how the
clinical trials fit into the four phases.
1:40:38 PM
MS. IVY said although she did not have specifics for each phase,
the average time is 10 to 15 years for the FDA approval process.
Clinical trials are part of Phases One, Two, and Three. HB 43 is
about drugs that have completed Phase One clinical trials, which
tests toxicity, so drugs are in Phases Two and Three.
1:41:46 PM
MS. IVY said with the FDA's compassionate care program, designed
for terminally ill patients without access to clinical trials,
patients must first work with their doctors to apply to the FDA.
By the FDA's own estimate, the application took 100 doctor hours
to complete. Recently the FDA has been trying to reduce that
time, but the application is only the first step in the process.
Manufacturers must also submit lengthy documentation. After an
application has made its way through the FDA internal process,
an individual must seek out an institutional review board for
approval.
1:42:53 PM
SENATOR BEGICH asked if any of the laws passed in the other 38
states impede the clinical trial process.
1:43:42 PM
MS. IVY said that has been a concern in other states with Right
to Try and the bill includes language that patients must be
unable to participate in clinical trials.
1:44:52 PM
SENATOR BEGICH asked if the bill applies only to people who
could not participate in clinical trials.
1:45:08 PM
MS. IVY said yes, and the goal is that clinical trials continue
to benefit from the process in place.
1:45:24 PM
SENATOR VON IMHOF asked what kind of data is collected in what
she would call a subset of clinical trials and how is it used,
if collected.
1:46:12 PM
MS. IVY explained that data, whether inside or outside the
clinical trials, is always important to manufacturers. They must
report that data to the FDA. That data is collected under
existing federal law
SENATOR VON IMHOF said that although there are no controls
outside of clinical trials, data is always important.
MS. IVY said 38 states have Right to Try legislation, and 11
states have legislation pending, including Alaska.
SENATOR GIESSEL asked why Hawaii vetoed its Right to Try bill.
1:48:07 PM
MS. IVY said Governor [Jerry] Brown in California vetoed this
legislation in 2015, but later reversed his veto. But Hawaii
Governor [David] Ige noted his veto before he later changed it.
Governor Ige listed four reasons for vetoing the bill: 1. The
FDA compassionate care process already provided access. 2. It
intervened with FDA system, which may have the inadvertent
consequence of delaying new drugs. 3. It violated the supremacy
clause. 4. He was unsure of patient benefits.
SENATOR VON IMHOF asked when the legislation was introduced and
vetoed in Hawaii and if there have been further discussions
about that legislation.
MS. IVY said it was vetoed in May 2016, and she would report
later on the current status of the legislation in Hawaii.
MS. IVY drew attention to Clinical Trials: A student's interview
of nurses, patients and survivors experience and opinions of
cancer and clinical trials in Alaska document in committee
members' packets. She said these stories helped to illustrate
the benefit of having access to new treatments.
1:51:18 PM
CHAIR WILSON pointed out that Claire Radford, from Legislative
Legal Services and Deb Stovern, the executive administrator, the
Alaska State Medical Board, were available to answer questions.
He asked how many Alaskans would benefit from the law.
MS. IVY replied that it is difficult to say, but for individuals
who would benefit, the impact would be enormous because it could
be the difference between life and death. Even if only one
person benefits, it would be worth it.
CHAIR WILSON asked if there was a time restriction for a patient
to be on a trial drug. If the FDA approval for a new drug is 10
to 15 years, could someone stay on a trial drug until the FDA
denied or approved the drug?
MS. IVY said every clinical trial is designed differently and
has different lengths and qualifications, so she could not
specifically address the question of time.
1:53:38 PM
SENATOR GIESSEL noted that in a February 2017 letter the Alaska
State Medical Board took a neutral position because a no use
clause is not included in the bill. Her interpretation is that
refers to a removal of the liability for a person who chooses a
clinician who chooses not to prescribe this. She did think the
bill addressed it on page 3, lines 10 and 11, but asked Ms. Ivy
to respond.
MS. IVY said that statement about no use referenced a Senate
bill. HB 43 does include language that would protect physicians,
manufacturers, and other stakeholders who would choose not to
participate for a variety of reasons.
1:55:12 PM
SENATOR GIESSEL asked if the no use issue was addressed in the
bill on line on page 3, lines 10 and 11, which reads, "a person,
acting in good faith and with reasonable care, is not liable in
an action for damages solely for declining to prescribe . . .
and provide."
MS. IVY said that is correct.
SENATOR GIESSEL asked MS Stovern if the State Medical Board
still stands by its neutral position on HB 43 as stated in its
February 2107 letter.
1:55:57 PM
DEBORA STOVERN, Executive Administrator, Alaska State Medical
Board, answered questions about HB 43. She apologized for
confusion in the letter, which was written for both SB 19, a
similar bill, and HB 43. The neutral position was for SB 19. The
board does support HB 43.
1:56:53 PM
SENATOR BEGICH asked if a drug being used under Right to Try
would still be used if it was ruled unsafe during clinical
trials.
MS. IVY said its use would be stopped. HB 43 clarifies
investigational drugs must remain in ongoing clinical trials.
SENATOR BEGICH stated that clarification makes him more
comfortable about the bill.
SENATOR GIESSEL called attention to the March 2017 letter from
Premera. Premera suggested that a new section be added to the
bill. Item B of this proposed section states that the patient's
"insurance plan is not required to pay, and may deny coverage"
if there's been demonstrated to be associated any harm or
adverse effect. She asked Ms. Ivy what language in HB 43
addressed this issue.
She then identified the language as being on page 2, line 10.
She brought up the suggested language in the Premera letter that
said that a health care insurer may, but is not required to, pay
for coverage for the investigative drug. She thought HB 43 did
not address insurance.
2:00:05 PM
MS. IVY responded that insurance coverage being referenced in
the letter is not required by state or federal statute.
Clarifying language could be added, but the sponsor didn't
include it since it is not required by state or federal law.
MS. IVY said the informed consent part of the bill involves a
discussion between a patient and doctor regarding the lack of
insurance for an investigational drug.
SENATOR GIESSEL said often pharmaceutical companies do not
charge for experimental medications. She asked how often that
happens with these types of experimental medications.
MS. IVY said federal law does allow for cost recovery, but
manufacturers cannot sell experimental drugs for profit. She
said she would need to do further research to find out how often
they are given away for no charge.
SENATOR GIESSEL asked whether it was true that if a patient is
accepted into a clinical trial, the patient does not pay for the
medication.
MS. IVY said she believed that is usually true, although there
are other costs a patient might have to pay for.
2:03:23 PM
SENATOR GIESSEL noted that part of the Premera letter suggested
a definition of a terminal illness that stated, "a reasonable
likelihood that death will occur within six months." HB 43 has a
different definition on page two, lines 14-16. She asked why HB
43 did not have Premera's language.
MS. IVY said the House discussed the definition of terminal
illness. The definition in the bill is one used by other states.
Premera offered Medicare's definition of 6 months. The sponsor
thought that timeframe was too narrow. The compassionate use
program does not have a definition for terminal illness.
SENATOR GIESSEL said the bill's definition of a terminal illness
on page 2, line 15, says "death in the near future," which is
nebulous. She asked what is "the near future."
2:06:10 PM
CLAIRE RADFORD, Staff, Legislative Legal Services, Alaska State
Legislature, answered questions about HB 43. She said the state
medical board would define any definitions that are not clear.
SENATOR GIESSEL said Ms. Radford was pointing out that under AS
08.64, the medical board would have authority to do this.
2:07:08 PM
SENATOR VON IMHOF said she was concerned about Premera's request
to add a section 5 to the bill of clarifying language for health
insurance. She wondered whether it wasn't the health insurance
policy that should state what coverage is. Health insurance
policies are updated on a regular basis, but that is not usually
true for statutes. She asked Ms. Ivy if she asked Premera/Blue
Cross and Blue Shield of Alaska how they handle the issue in
their policies and what they cover for clinical trials.
MS. IVY said in conversations with Premera/Blue Cross she did
not ask for copies of policies and how they handled coverage.
The sponsor may agree that referencing a point in time in
statute can be problematic. The elements of pointing out what is
not covered is not currently required by state or federal
statute. The suggested Section 5c in the Premera letter about
what would be covered is mandated in the [federal] Affordable
Care Act (ACA). If the ACA changes then the state statute would
have to be changed. The bill's current language would not
require any changes in current statutes. She offered to research
how insurance policies currently address the issue.
2:10:24 PM
SENATOR BEGICH asked when the 38 states passed their laws and
how are they working.
MS. IVY said the Right to Try legislation movement started in
2014. Florida, Oregon, and Texas have some success stories. In
Texas, a doctor used a promising treatment available in Europe
with 150 patients, but the FDA would not allow him to continue
to treat his patients when the trials were completed. He was
able to resume treatment after Texas passed its Right to Try law
and many patients, who were given three to six months to live,
are still alive a year later.
2:12:31 PM
SENATOR BEGICH relayed a story of a close friend with pancreatic
cancer who was given 6 months to live. He left the country for a
clinical trial. He lived long enough for his daughter, who was 4
years old at the time of his diagnosis, to have memories of him.
It almost bankrupted his friend's family. He said the proposal
is overdue because the opportunity to extend life is important.
SENATOR GIESSEL asked whether the states that did not have Right
to Try laws have offered legislation.
MS. IVY said yes, all have Right to Try legislation introduced.
2:14:37 PM
CHAIR WILSON opened public testimony
2:14:55 PM
STARLEE COLEMAN, Senior Policy Advisor, Goldwater Institute,
provided information on Right to Try laws. She said the FDA
compassionate care program, particularly for patients in Alaska,
is not a practical option. About 1,200 people a year make it
through the FDA's compassionate care process. About 25,000
people a year are in a similar program in France. France, a
country with a population one-fifth size of the United States,
helps 2,000 percent more people. America has a red tape problem.
The Institute receives two responses from doctors when
discussing the compassionate care program: the what program and
oh, that is impossible.
2:16:43 PM
MS. COLEMAN said according to a doctor who ran the early stage
clinical trials center, the largest in the world, at the MD
Anderson Cancer Center in Houston, the center was only able to
get one person a year into the FDA compassionate care program.
Imagine the obstacles in Alaska. Practical opportunities for
people who are not in big hospitals in big cities to have access
to clinical trials are not good. Right to Try legislation is one
of the only options for people in these situations. The
institute has talked to hundreds of families and has heard the
same thing. No one expects a guarantee, but they want the
opportunity to try. "We feel we owe dying people and their
families that opportunity," she said.
2:20:44 PM
MS. COLEMAN said the question has come up about whether these
laws conflict with federal law. States have the authority to
provide additional constitutional rights above the federal
floor. States can go above what is guaranteed in the
Constitution. There have been no efforts by the FDA to shut down
these laws or intervene in treatment.
MS. COLEMAN said the U.S. Senate last summer unanimously passed
a law to protect states that have passed Right to Try laws from
federal interference. They are hoping the U.S. House will pass
the law soon and Alaska will know it will have the federal stamp
of approval for this law.
2:24:09 PM
SENATOR BEGICH asked if she said the federal law passed
unanimously in the U.S. Senate.
MS. Coleman said that is correct.
2:24:35 PM
CHAIR WILSON opened public testimony.
2:25:02 PM
KEN LANDFIELD, Representing Self, testified in support of HB 43.
He said he could not imagine any reason not to support this
bill.
2:26:10 PM
CHAIR WILSON closed public testimony.
2:26:24 PM
CHAIR WILSON held HB 43 in committee.