Legislature(2015 - 2016)BUTROVICH 205
02/24/2016 01:30 PM Senate HEALTH & SOCIAL SERVICES
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| Audio | Topic |
|---|---|
| Start | |
| SB113 | |
| SB156 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| *+ | SB 113 | TELECONFERENCED | |
| *+ | SB 156 | TELECONFERENCED | |
| + | TELECONFERENCED |
SB 113-NEW DRUGS FOR THE TERMINALLY ILL
1:32:09 PM
CHAIR STEDMAN announced the consideration of SB 113.
1:32:59 PM
SENATOR GIESSEL moved to adopt the CS for SB 113, labeled 29-
LS0783\H, as the document before the committee.
CHAIR STEDMAN objected for discussion.
1:33:17 PM
SENATOR BILL WIELECHOWSKI, Alaska State Legislature, as sponsor,
introduced SB 113. He noted that the bill is called the "Right
to Try Act." It allows terminally ill patients to work with
their doctors and drug or device manufacturers to access
investigational treatments that have passed the Federal Drug
Administration's (FDA) safety testing phase - Phase 1 - but are
not yet widely available. More than a million Americans die
every year from terminal illness.
CHAIR STEDMAN requested to hear the change made in the CS.
1:34:06 PM
BROOKE IVY, Staff, Senator Wielechowski, Alaska State
Legislature, explained the changes in version H of SB 113. She
reported that SB 113 has had three iterations; version A,
version W, and now version H. She related that in version H on
page 1, line 10, provisions to prevent any damage to clinical
trial participation were added by ensuring that patients had
already attempted to enter a clinical trial. The language in
Section 1 states that patients must be "ineligible or unable to
participate in a clinical trial" as part of their condition.
MS. IVY related that on page 2 of Section 1, the requirement for
hospitals and healthcare facilities to participate was repealed.
Language was added that the investigational drug shall remain in
an on-going clinical trial in order to clarify that the
investigational drug is in Phase 2 or Phase 3 of the FDA
approval process.
She said on page 2, line 21, immunity protections for medical
team members, in addition to physicians, was added. On page 3,
line 12, a fourth section was added because the previous section
was repealed. Section 4 says it is optional for hospitals and
healthcare facilities to participate in order to accommodate
physicians prescribing, dispensing, or administering
investigational drugs to a patient, and DHSS cannot require them
to do so.
1:36:39 PM
MS. IVY said in Section 4 of version W, it stated that "a
licensed entity may not be subject to investigation or an
enforcement action for failing to increase services." The only
change from version W to version H was stating that the
department may not be required to provide additional services.
1:37:20 PM
CHAIR STEDMAN removed his objection. There being no further
objection, version H was adopted.
He noted the presence of Senator Stoltz.
1:38:22 PM
SENATOR WIELECHOWSKI explained the origins of SB 113. He said
the bill is known as the "Right to Try Act" and has passed in 24
states and been introduced in virtually every other state. He
related that SB 113 sets up a legal framework that allows
terminally ill patients to work with their doctors and drug and
device manufacturers to access investigational treatments that
have been passed the FDA's safety testing phase, but are not
widely available. It would expand access to potentially life-
saving treatments years before patients would normally be able
to access them. The problem is the bureaucratic process in the
FDA can take years, and fewer than 3 percent of terminally ill
patients gain access to treatments through clinical trials. This
legislation is designed to try and make those treatments
available to the other 97 percent.
He noted he worked on the legislation with Kurt Altman, an
expert from the Goldwater Institute in Arizona. He emphasized
that this issue cuts across party lines. It enjoys overwhelming
bi-partisan support in the states where it has passed.
MS. IVY explained that the goal of the bill is to create a legal
climate in which terminally ill patients, who have exhausted all
FDA-approved treatment options, may work with their doctors and
drug manufacturers to access investigational treatments that
have passed Phase 1 of the FDA approval process, but are not yet
widely available.
MS. IVY said version H has four sections:
Section 1 of the bill prohibits the State Medical Board from
taking disciplinary action against physicians for prescribing or
administering an investigational drug to a terminally ill
patient that meets certain criteria. Patients under this section
must be ineligible or unable to participate in an ongoing
clinical trial, have considered all other approved treatment
options and have provided written consent.
Section 2, a new section in AS 09.65, establishes that
physicians, medical team members, manufacturers, importers and
distributors, "acting in good faith and with reasonable care,"
will 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 informed consent was obtained from the patient,
and notice of immunity was also given to the patient, in
advance.
Section 3 adds a new section to AS 17.20.110, a statute limiting
the sale and distribution of new drugs. The new section will
allow physicians to prescribe or administer investigational
drugs under the conditions established in Section 1.
Finally, Section 4 would prevent the Department of Health and
Social Services from requiring a licensed health care facility
to increase its services solely to accommodate physicians who
are prescribing or administering investigational drugs to a
patient.
1:42:12 PM
MS. IVY reviewed the four phases of the FDA drug review process:
Prior to Phase 1 is when sponsors of a drug are required to
submit what's called an Investigational New Drug (or IND)
Application - it is through this application process the FDA
reviews the applicant's preclinical testing results and
determines whether the drug is reasonably safe for testing in
humans.
Phase 1 studies occur after the approval of the Investigational
New Drug Application. These studies may be conducted on healthy
volunteers in cases of testing on drugs like ibuprofen or anti-
inflammatories, or on individuals with a specific disease or
terminal illness. The goal of Phase 1 testing is to determine
possible side effects and toxicity levels. Basically, Phase 1
focuses on safety.
Phase 2 studies begin when a drug passes Phase 1 and is
therefore considered relatively safe (no unacceptable toxicity
levels). While Phase 1 focuses on safety, Phase 2 focuses on a
drug's effectiveness.
If there is evidence a drug is effective, it will then progress
to Phase 3. This is where more information is gained on safety
and effectiveness, particularly in varying populations, at
different dosages and in combination with other medications.
After Phase 3, sponsors of the drug then have a review meeting
with the FDA, and go on to complete a New Drug Application,
which if approved, would allow them to market the drug in the
United States. From there the FDA has 60 days to decide whether
to officially "file" the application for review. If filed,
applications are generally processed within 10 months.
1:44:24 PM
MS. IVY explained that when the term "investigational drugs" is
used in Senate Bill 113, it refers to those experimental drugs
that have passed safety testing in Phase 1, and that remain in
ongoing clinical trials in either Phase 2 or Phase 3 of the FDA
approval process.
She addressed the purpose of the legislation. Each year, it is
estimated that over one million Americans die from a terminal
illness. Many individuals diagnosed with a fatal condition may
spend years searching for a cure or a viable treatment. 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.
In recognition of the 97 percent of patients denied access to
clinical trials, the FDA does have a program in place for
accessing investigational drugs outside of clinical trials,
known as the "compassionate use" program. Nevertheless, it's
estimated that only about 1,000 people make it through this
federal process each year.
By the FDA's own estimate, the program's application form alone
can take 100 hours for a doctor to complete. In an effort to
streamline the process, the FDA did announce plans in February
of 2015 to shorten the application. However, a year has now
passed and the new form has yet to be made available. The
application is only the first step. Manufacturers must also
submit lengthy documentation. Once complete, application
paperwork must then make its way through the FDA, and then to a
separate Institutional Review Board for approval, an often
lengthy, multi-month process.
1:46:38 PM
She stated that given this information, the goal of Senate Bill
113 is to provide the same access as the FDA's existing
"compassionate use" program, but on shorter timeline. By
ensuring terminally ill patients have more timely access to
safe, but experimental drugs, in consultation with their doctor,
SB 113 attempts to offer new hope when all FDA-approved options
have been exhausted
She noted items in members' packets:
1) An Updated NCSL Legislative Map (1-4-2016). Although this
th
map was published on January 4 of this year, it is already
out of date. As of today, 47 states have now seen "Right to
Try" legislation either introduced or passed. Of those, 24
states have signed the "Right to Try" into law with
overwhelming bi-partisan, and often unanimous, support.
The Indiana - (H), Georgia - (H), Texas - (S), Nevada -
(H&S), North Carolina - (H&S) are just a sampling of
legislative bodies that put their unanimous support behind
the "Right to Try." 22 states also currently have
legislation pending, including Alaska. For the record,
this now adds WA, ID, KS, KY, WV, GA, SC, MD, RI & VT to
the map as "pending." Please also note the map contains an
error: NH has not yet passed the "Right to Try," but it is
currently pending.
2) Sponsor Statement - note that state legislation numbers
reference in the sponsor statement, being based on this
map, are now incorrect.
3) Goldwater Institute Policy Report - an abbreviated version
of the Goldwater Institute's Policy Report.
The Policy Report goes into greater detail on the
challenges of the FDA's "compassionate use" program, and
tells the story of Kianna Karnes, a 41 year old diagnosed
with kidney cancer who passed away before she could receive
access to an investigational drug that may have helped her.
To read a quick excerpt from the executive summary:
"In the case of Kianna Karnes, she had a better chance than
most patients at receiving expanded access. As her father
explained, "Here is a case where her old man understood
clinical trials. I knew about compassionate use; I had a
friendship with a powerful member of Congress; I've got the
Wall Street Journal behind me. But I still couldn't save
her life. Now, what about the thousands of people out there
who don't have these kinds of resources available to them?"
To most patients, and many physicians outside of major
institutions, the process of obtaining expanded access is
excessively time-consuming and extremely difficult to
navigate."
For those members who are interested, the full report is
now available on Basis.
4) Clinical Trials - a document entitled "Clinical Trials."
While SB 113 focuses on terminally ill patients who do not
qualify for clinical trials, we felt the inclusion of these
Alaskan stories would help to illustrate local experiences
with terminal illness, as well as the benefit of simply
having access to new treatment options, clinical trial or
not.
1:49:50 PM
SENATOR STOLTZE requested a definition of biological products
and information whether FDA's testing "not doing harm" must also
"show that it does good."
1:50:28 PM
MS. IVY deferred to Mr. Altman to answer.
SENATOR STOLTZE voiced concern about product contents leading to
false hopes.
CHAIR STEDMAN opened public testimony.
1:52:45 PM
KURT ALTMAN, Counsel, Goldwater Institute, presented information
about SB 112. He said he is the drafter of the model legislation
SB 113 is generally fashioned after. He said he has been to
about 30 to 35 states and has met with stakeholders,
legislators, legal panels, FDA doctors, pharmaceutical
companies, and insurance companies for about two years. He
explained that the bill would allow terminal patients, on the
recommendation of their physicians, to access investigational
new drugs, biologics, or devices that have passed Phase 1 of FDA
testing and remain in the testing process. He said a common
misperception is that a drug can pass Phase 1 and be marketed to
desperate people. The "Right to Try" was designed to prevent
that and there are a number of safeguards. A company cannot get
a drug through Phase 1 and then market it to the public.
1:56:24 PM
MR. ALTMAN continued to describe the FDA approval process and
stressed that the bill does not take people away from clinical
trials. He used the cell phone as an example of how technology
has advanced and compared it to medical technology advances,
which have often outpaced the FDA process. Many drugs are in
their 12th year of clinical trials and it is nearly impossible
for patients to access those drugs. The bill would keep the
access to these drugs between the doctor and the patient.
1:58:37 PM
MR. ALTMAN defined biological products as cells - plant or human
- that are injected into the body. He said there is a
significant concern about charlatans trying to take advantage of
desperate people. Right to Try has made that nearly impossible
because the drug has to pass FDA's Phase 1 and remain in Phase 2
or 3. That means it is a legitimate drug and it would be
provided for free or for cost of production. Federal statute
prohibits any profit to a company for sale of a drug that has
not been officially approve for marketing. The process is
designed not to make money off of desperate people.
2:01:16 PM
SENATOR STOLTZE asked if the cells could be from an aborted
child.
MR. ALTMAN said no.
SENATOR STOLTZE questioned, "Absolutely no?"
MR. ALTMAN replied, "Absolutely no."
2:02:20 PM
MICHAEL MAHARREY, National Communications Director, 10th
Amendment Center, testified in support of SB 113. He said his
organization has been involved in, and supportive of, the Right
to Try from the beginning. He provided statistics related to the
time it takes to get a drug approved. He said the bill is a
perfect example of states exercising their rightful authority to
exercise control over local issues. It would expanded access to
treatments for the desperately ill.
2:05:47 PM
KEN LANDFIELD, representing himself, testified in support of SB
113. He referred to the Hippocratic Oath to do no harm, and
wondered how much harm could be done to a terminally ill person
under guidance of their physician. He thought the Right to Try
should be an option.
SENATOR WIELECHOWSKI said he appreciated the opportunity to
present SB 113. He concluded it is an important bill that
crosses party lines and potentially saves lives.
CHAIR STEDMAN held SB 113 in committee.