Legislature(2017 - 2018)ADAMS ROOM 519
04/11/2018 01:30 PM House FINANCE
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| Audio | Topic |
|---|---|
| Start | |
| HB384 | |
| SB32 | |
| HB384 | |
| SB32 | |
| HB306 | |
| SB4 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| += | HB 339 | TELECONFERENCED | |
| += | SB 32 | TELECONFERENCED | |
| + | SB 4 | TELECONFERENCED | |
| + | TELECONFERENCED | ||
| += | HB 306 | TELECONFERENCED | |
| += | HB 384 | TELECONFERENCED | |
SENATE BILL NO. 32
"An Act relating to biological products; relating to
the practice of pharmacy; relating to the Board of
Pharmacy; and providing for an effective date."
Co-Chair Foster relayed that SB 32 was last heard in
committee on May 3, 2017.
3:36:12 PM
SENATOR SHELLEY HUGHES, SPONSOR, provided a review of the
legislation. She reported that since the bill was last
heard the Alaska Board of Pharmacy decided to support the
bill and that 41 states adopted similar legislation; an
increase from 33 in 2017. She detailed that a biologic was
made from a living cell and had a complex molecular
structure. The drugs were the fastest growing type of
"therapeutic products." Approximately three dozen biologic
medicines were used to treat serious and chronic diseases
for thousands of Alaskans. Additionally, a generic drug
could be substituted by a pharmacist because it contained
"identical chemical recipe." Biological products differ
from traditional generics and were not able to replicate
exactly due to its complex compounds therefore generic
biologic medicines were not identical and were considered
"biosimilar." The federal Food and Drug Administration
(FDA) developed a "gold standard" or criteria for
biosimilar products and labeled them "interchangeables." An
interchangable biosimilar was highly similar to the
original biologic and had been found to produce similar
clinical results. The bill would update current laws to
allow a pharmacist to substitute interchangeable
biosimilars for prescribed brand-name biologics that were
approved by the FDA but maintained the prescribers control
by authorizing them to specify whether a substitution was
allowable. Patient consent was also required before any
substitution was made. The chemical results would be the
same. The legislation required that within three days after
dispensing, the pharmacist must communicate to the
physician the specific biologic product dispensed.
3:40:38 PM
Representative Kawasaki asked whether patient consent for
the substitution was necessary. Senator Hughes responded in
the affirmative. Representative Kawasaki asked about the
gold standard for interchangeable biosimilars and wondered
what the standard was. Senator Hughes replied that the
FDA's definition of an approved biosimilar was that the
"interchangeable would produce the same clinical result as
the referenced product in any given patient."
Representative Kawasaki asked how the process worked when
the pharmacist communicated to the prescribing practitioner
what specific biologic substitute was dispensed. Senator
Hughes relayed that it would happen via an electronic
system, emails, or phone calls and allowed 3 business days
for the communication.
Co-Chair Foster moved to invited testimony.
3:44:29 PM
Co-Chair Foster OPENED public testimony.
3:44:58 PM
RICHARD HOLT, CHAIRMAN, BOARD OF PHARMACISTS, ANCHORAGE
(via teleconference), indicated that the board supported SB
32. He reported that the field of biologic medicine was
rapidly growing, and the board needed to stay focused on
the industry. He noted that currently Alaskan pharmacists
would not be able to offer interchangeables and was in full
support of the bill.
Representative Wilson related that the board would be
required to post and maintain a link to the FDA's list of
all currently approved interchangeable biological products
on the board's website. She asked whether the board was in
support of the requirement. Mr. Holt replied in the
affirmative.
3:47:16 PM
MARC BOAS, SELF, ANCHORAGE (via teleconference), was a
current patient with the chronic illness, psoriasis. He
spoke in support of SB 32. He indicated that he was an
advocate for a chapter of the National Psoriasis
Foundation. He delineated that conventional drug treatment
results diminished over time. Biosimilars offered
significant relief and cost savings. He believed the bill
provided the correct pathways to gain access to the
appropriate interchangeables while protecting the patient.
He urged members not to delay passage of the bill. He
thanked members for their support.
3:49:41 PM
AT EASE
3:49:56 PM
RECONVENED
Co-Chair Foster would be passing the gavel to Vice-Chair
Gara.
SHAINA SMITH, U.S. PAIN FOUNDATION, WASILLA (via
teleconference), spoke in favor of the legislation. She
read from a foundation member's letter who was a decorated
veteran and experienced chronic pain for over 45 years. He
relayed his experience with relief from rheumatoid
arthritis from a biologic medicine. He supported the
opportunity to have an FDA substitution in the case he
built resistance to his current biologic. He supported the
bill.
3:52:08 PM
ASHLYN ANTONELLI, SELF, ANCHORAGE (via teleconference),
spoke in favor of the bill. She shared that she was a brain
tumor survivor and currently struggled with psoriatic
arthritis and provided details about her health. She
supported the ability to be prescribed a biosimilar
substitute and noted that many other states had approved
the substitutions. She related that her pain was
debilitating, and she had to take a three-hour nap when she
got home from work. She hoped the committee would put
itself in the position of a person with chronic illness to
understand the need for supporting the legislation.
3:55:11 PM
TERRY MCCLELLAND, SELF, ANCHORAGE (via teleconference),
testified in support of the bill. He related that he was a
volunteer for the Colorectal Cancer Alliance. He shared
that he had cancer twice and was medically prohibited from
receiving any further chemotherapy or radiation. He wanted
the bill to pass to ensure all Alaskans had access to other
options.
3:56:50 PM
Vice-Chair Gara noted he was signing on as a co-sponsor for
the bill.
Vice-Chair Gara CLOSED public testimony.
3:57:24 PM
AT EASE
3:58:14 PM
RECONVENED
Representative Guttenberg asked what the difference between
a biologic and biosimilar was.
RYLAN HANKS, DIRECTOR OF REGULATORY POLICY, AMGEN, LOS
ANGELES, CALIFORNIA (via teleconference), replied that
since biologics were made with living cells exact
replications were impossible. He explained that a patient's
immune system recognized the biologic by responding in
certain ways to the small molecules. Because of the slight
differences in the small molecules between a biologic and
biosimilar, the biosimilar was not an exact copy. The way a
biosimilar reacted in the body was highly similar but not
exactly the same.
Senator Hughes appreciated the committee's time. She
commended her staff, Aimee Bushnell, for working hard on
the bill.
Vice-Chair Gara MOVED a conceptual amendment.
Representative Wilson OBJECTED for discussion.
Vice-Chair Gara explained Conceptual Amendment 1. He cited
that on page 4, line 17, the effective date was changed
from July 1, 2017 to July 1, 2018 and on page 4, line 18
the year 2018 was changed to 2019.
Representative Wilson WITHDREW her OBJECTION.
There being NO further OBJECTION, Conceptual Amendment 1
was ADOPTED.
Representative Kawasaki asked whether the bill applied
specifically to interchangeable biological products only.
Senator Hughes replied in the affirmative. She detailed
that an interchangeable was a sub-category of a biosimilar
and only an interchangeable biosimilar could be
substituted. Representative Kawasaki pointed to an FDA
document and read the following:
An interchangeable biological product may be
substituted for the reference product by a pharmacist
without intervention by a healthcare provider who
prescribed the product?
Representative Kawasaki restated his question regarding the
provision that the pharmacists must notify the prescriber
of the substitution. Senator Hughes answered that the FDA
did not require pharmacist's notification. However, patient
groups across the country requested the notification and
all 41 states included the notification requirement in
response to public outcry.
4:03:54 PM
Vice-Chair Gara reviewed the new fiscal impact note from
the Department of Commerce, Community and Economic
Development (DCCED) in the amount of $4,500 for the
regulatory process.
Vice-Chair Gara MOVED to REPORT HCS SB 32(FIN) out of
committee with individual recommendations and the
accompanying fiscal note. There being NO OBJECTION, it was
so ordered.
HCS SB 32(FIN) was REPORTED out of committee with a "do
pass" recommendation and with one new fiscal impact note
from the Department of Commerce, Community and Economic
Development.
4:05:55 PM
AT EASE
4:06:52 PM
RECONVENED