Legislature(2017 - 2018)SENATE FINANCE 532
03/29/2017 09:00 AM Senate FINANCE
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| Audio | Topic |
|---|---|
| Start | |
| SB32 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| += | SB 31 | TELECONFERENCED | |
| *+ | SB 32 | TELECONFERENCED | |
| *+ | HB 57 | TELECONFERENCED | |
| + | 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."
9:04:38 AM
Co-Chair MacKinnon invited the sponsor and staff to present
the bill.
SENATOR SHELLEY HUGHES, SPONSOR, discussed the bill. She
relayed that the bill provided safe access to a new,
affordable, Federal Drug Administration (FDA) approved
treatment option called "interchangeable biologic
products." She asserted that the State Medical Association
and Alaska State Hospital and Nursing Home Association
(ASHNHA) supported the bill.
Senator Hughes discussed generic medical products and how
they differ from biologic products. She stated that generic
prescription drugs were 100 percent identical to the
corresponding medical product. She conveyed that bio-
similar products were made from living cells and could not
be replicated identically. Biologic products include
insulin and Humira. She detailed that the FDA was on the
verge of creating a new category of drugs called
"interchangeable biologic products."
9:07:49 AM
Senator Hughes continued discussing bio-similar drugs,
indicating that there would be a very specific category of
biologics that were not a 100 percent copy, and that there
could be a very slight variance from the original. The bill
would require a pharmacist to notify the physician of the
substitution with the interchangeable biologic product.
The new category of "interchangeables" would be so similar
to the original drug that there would be no discernable
clinical difference. She emphasized the importance of
allowing pharmacists to substitute them, as they carried a
far lesser cost. She highlighted that this category had not
passed the FDA, but was in the pipeline, and legislation
needed to be put in place. She thought the issue needed to
be addressed to ensure Alaskans who were suffering from
serious conditions could access the drugs as soon as they
passed the FDA.
9:10:52 AM
Senator Olson asked if a patient would have to request a
biologic in lieu of the prescribed product.
Senator Hughes stated that a doctor may prescribe a
biologic, and the pharmacist would be able to substitute an
"interchangeable" and then notify the physician. She
relayed that the terms "dispense as written" and "call if
substitution" would mean the pharmacist could not make that
determination. The bill would not change the prescribing
doctor's authority over the prescription. No prior
authorization would be needed, but notification would be
required.
Senator Olson asked if a pharmacist could make the
substitution if the patient did not request it
specifically.
Senator Hughes answered that a patient retained control and
could request the original product that had been
subscribed.
9:13:16 AM
Senator von Imhof relayed that she had heard the bill in
the Senate Health and Social Services Committee, where
there had been a rich and robust discussion. She underlined
that the product would be FDA-approved. She thought the
bill provided the flexibility for the doctor or patient to
stipulate that the prescribed product not be substituted.
She thought it was important to note that under the bill, a
pharmacist would have a three-day window in which to notify
the prescribing doctor. The patient would have to be
informed at the time of filling the prescription, and would
have a variety of options, including requesting the
original product. She asked the sponsor for confirmation.
Senator Hughes answered affirmatively, and stated that the
patient would be informed and could refuse the
interchangeable product.
Senator Hughes pointed out that some history would be
helpful in understanding the bill. She recounted that there
had been a robust discussion between physicians, nurse
practitioners and other prescribers. Originally physicians
had wanted to require prior authorizations. Pharmacists had
countered that they were qualified to fill prescriptions
without waiting for authorization. The notification was
consensus language that had been worked out between
physician and pharmacist groups. She continued that younger
doctors were happy to proceed without the notification
period, however it had been left in as the product was not
identical to the originally prescribed product.
9:16:40 AM
Senator von Imhof added that legislation similar to the
bill had already passed in 26 states, and the proposed
process had been occurring successfully in Europe for many
years.
Senator Hughes concurred.
9:17:04 AM
Senator Olson asked about a letter of opposition from
representatives of the pharmacist community and wondered
what had been the objection.
Senator Hughes thought there had been concern about the
notification requirement. She reiterated that the
notification provision had been worked out and was
streamlined.
Senator Olson identified that there were three boards in
the state that oversaw prescriptive authority. He asked
whether the sponsor had heard from nurse practitioners.
Senator Hughes was not sure whether they had and would
check with her staff.
AIMEE BUSHNELL, STAFF, SENATOR SHELLEY HUGHES, stated that
she had been approached by nurse practitioners asking
whether other groups had supported the legislation.
Senator Olson asked whether the state medical board had
supported it.
Ms. Bushnell relayed that the Alaska State Medical Board
had submitted a letter of neutrality.
9:19:22 AM
Ms. Bushnell reviewed the document "SB 32 Interchangeable
Biological Products - Sectional Analysis":
Sec. 1 - AS 08.80.030
Adds a new subsection requiring the Board of Pharmacy
to have a link on the board's website to the United
States Food and Drug Administration's (FDA) list of
approved interchangeable biological products.
Sec. 2 - AS 08.80.294
Amends this section by requiring a pharmacist to
include on the label of a biological product container
the proprietary or proper name of the biological
product. This section also includes language to
differentiate between drugs that are and are not
biological products to ensure that statutes regarding
equivalent generic drugs are not substantively
changed.
Sec. 3 - AS 08.80.294
Adds a new subsection to define the term "proper name"
being the name that reflects scientific
characteristics of a biological product. This new
subsection also defines "proprietary name" which is
the trademarked and registered name of the product.
Sec. 4 - AS 08.80.295
Adds language to differentiate between equivalent drug
products and interchangeable biological products.
Sec. 5 - AS 08.80.295
Adds new subsections to provide guidelines as to how
pharmacists or their designee will need to communicate
with a prescribing doctor when dispensing a biological
or interchangeable biological product if an
interchangeable product is available.
Under subsection (c), a pharmacist must communicate to
the prescribing doctor the name and manufacturer of
the biological product provided to the patient. This
communication must happen within three days after
dispensing the product by an entry through an
interoperable electronic medical records system, an
electronic prescribing technology, a pharmacy benefit
management system, or a pharmacy record. If an entry
under this subsection is not possible, the pharmacist
may communicate by e-mail, telephone, fax, or by any
other prevailing means.
Under subsection (d) provides an exception to the
communication requirement under (c) if the dispensed
biological product is a refill of the prescription and
is the same biological product. Subsection (e)
provides that communication provided under (c)(1) of
this section is providing notice to the prescribing
doctor. Under subsection (f), a pharmacist is required
to maintain a record for two years after a biological
product is dispensed. Finally subsection (g) defines
"designee" as an agent or employee of a pharmacist who
has been authorized to communicate information under
subsection (c).
Sec. 6 - AS 08.80.480(34)
Changes language, and gives option to change the term
"drug" and "equivalent drug" to "biological product"
and "interchangeable biological product".
Sec. 7 AS 08.80.480
Adds new subsection (37) to define term "biological
product".
Adds new subsection (36) to define term
"interchangeable biological product" as a biological
product as determined by the United States Food and
Drug Administration.
Under subsection (A) provides that it meets the
standard for interchangeability under US code
(Regulation of biological products, Safety standards
for determining interchangeability).
Under subsection (B) provides that it is
therapeutically equivalent in the most recent edition
of the United States Food and Drug Administration
evaluations.
Sec. 8 AS 08.80.480
Amends this section by adding transition regulations
if necessary to implement changes made by
this Act. Having changes take place in accordance with
AS 44.62 (Administrative Procedure Act) but not before
the effective date of this Act.
Sec. 9 AS 08.80.480
Adds language that section 8 of this Act takes effect
July 1, 2017.
Sec. 10 AS 08.80.480
Adds language that this Act will take effect January
1, 2018, except for a provided in section 9.
9:21:13 AM
Senator Hughes added that she had received a letter of
neutrality from the Alaska State Medical Association
initially, and later the board had submitted a letter of
support.
Ms. Bushnell informed that currently there were 29 states
and Puerto Rico that had passed similar legislation and two
states in the process of doing the same.
9:22:03 AM
Co-Chair MacKinnon OPENED public testimony.
9:22:10 AM
AT EASE
9:22:46 AM
RECONVENED
Co-Chair MacKinnon informed the committee that she had
received a list of testifiers from the sponsor.
9:23:05 AM
RYLAN HANKS, AMGEN, LOS ANGELES (via teleconference),
testified in support of the bill. He relayed that he was
Director of Regulatory Policy for biotechnology company
Amgen, which made biosimilars. He was also a practicing
pharmacist. He was formerly with the FDA in the Office of
Generic Drugs. He noted that biosimilars were in the
process of coming to market. The FDA was in the process of
outlining guidelines for these products. He wanted to
ensure that good communication happened between patients,
pharmacists and physicians.
9:24:37 AM
JEANNIE MONK, ALASKA STATE HOSPITALS AND NURSING HOMES,
JUNEAU, spoke in support of the bill. She was the Vice-
President of Policy and Programs for ASHNHA. When the
legislation first came forward the organization had
consulted with hospital-based pharmacists and physicians to
ensure the bill would provide guidance needed to give safe
and effective treatments to patients while providing
potential to lower pharmaceutical costs. Based on the
positive views held, ASHNA had made the decision to support
the bill. She specified that the communication and timeline
required were critical elements to ASHNA's support. The
legislation included a three-day notification period for
pharmacists to contact the prescribing physician. It also
provided accessibility and affordability as well as
competition for biological drugs in the way that generics
did for brand name drugs. She believed the legislation
protected patients and benefitted the state of Alaska.
9:26:27 AM
Senator Olson asked if Ms. Monk was familiar with the
situation in the health corporations in rural Alaska.
Ms. Monk replied that she had some knowledge of the
situation.
Senator Olson asked whether she had visited those areas.
Ms. Monk relayed that she had been in Bethel two weeks
previously.
Senator Olson asked Ms. Monk whether the organization had
discussed the current legislation with rural health
corporations and what their response had been.
Ms. Monk specified that ASHNHA had shared the information
with their partners and there had been no response.
Senator Olson asked about adverse reactions.
Ms. Monk stated that there was no concern expressed about
the language in the bill including the notification and
process of using biologic drugs. She noted she was not a
medical provider and could not speak to any risks, but no
one had expressed concern to the organization about risks.
9:27:37 AM
MARK GUIMOND, THE ARTHRITIS FOUNDATION, WASHINGTON D.C.
(via teleconference), spoke in support of the bill. He
thought biologic products changed lives in a positive way.
He stated it made the difference between a child being in a
wheelchair, or someone being on disability aid, and living
an active life. He furthered that biosimilar products were
composed of living cells and would be injected or
intravenous. They were not products that would be readily
available outside a pharmacy. In Alaska, retail pharmacies
dispensed about 1,100 medical products a week, and these
products would represent only 13 of that 1,100. Biosimilars
offered a more affordable option. The foundation supported
the communication stipulation within the bill. He
underlined that it had been a part of every other similar
piece of legislation that had passed, and Alaska would be
aligned with other states in maintaining it. He relayed
that the majority of arthritis patients also suffered from
additional chronic conditions and knowing the specifics of
the drug product was vital to ensuring that those other
medications were not affected.
9:29:56 AM
ASHLYN ANTONELLI, SELF, ANCHORAGE (via teleconference),
testified in support of the bill. She had suffered from a
brain tumor and other chronic pain illnesses. Her course of
therapy had included biologic products. If her doctor had
not prevented the substitution and it was FDA approved, she
wanted that option. She wanted the substitution recorded
for her doctor. She agreed with the three-day notification
rule. She did not want to wait for future legislation to
enable her to benefit from the new products. She discussed
her personal experience with high costs of the other
biologics. She answered a query about anaphylactic shock
previously posed to the sponsor by Senator Olson, stating
that it had taken six weeks to appear and that she did not
think it would happen within three days.
Senator Olson asked about her experience with adverse
reactions and asked for verification that it had manifested
in a rash.
Ms. Antonelli recounted having an allergic reaction to a
drug and seeing a specialist to find another drug to
counteract the reaction. She detailed that it had taken
about six weeks for the rash to appear. She felt that in
the three-day notification period, her doctor would be
fully informed of which medication she was taking.
Senator Olson asked if Ms. Antonelli knew about HLA-B27. He
wondered how she knew that the biologic was the cause of
the allergic reaction.
Ms. Antonelli replied that her doctor had staggered
administration of the drug. She discussed the timing of
prescription aimed at determining which product had caused
any reactions.
9:34:29 AM
ROBERT THOMS, SELF, MAT-SU (via teleconference), spoke in
support of the bill. He discussed his decorated military
experience. He informed that he suffered from chronic pain
for the last 45 years. He had been on a non-biologic
medication and had suffered adverse effects. He had
switched to a biologic product that had benefitted him
tremendously. He was concerned that his medication may
cease working. He had taken an allergy medicine that had
stopped working, and he had subsequently used a substitute
which had begun working immediately. He discussed a
previous bill hearing at which an individual had questioned
the need for haste in passing the bill. He responded that
the bill was needed in advance of those products coming
onto the market so that patients could make immediate use
of them.
9:37:18 AM
CINDY CASERTA, US PAIN FOUNDATION, MAT-SU (via
teleconference), testified in support of the bill. She
stated that the bill would help all patients who needed
immediate access to the products in question. She discussed
her personal experience caring for her husband.
Senator Olson thanked Mr. Thoms for his service.
Co-Chair MacKinnon thanked Mr. Thoms on behalf of the
entire committee.
9:38:55 AM
KERRY MCCLELLAND, COLON CANCER ALLIANCE, ANCHORAGE (via
teleconference), testified in support of the bill. He was a
cancer survivor and hoped the legislation could make the
products available as soon as possible. He stated that if
his cancer were to return, he wanted to access the drugs in
question in-state rather than having to travel to the Lower
48.
9:40:20 AM
Co-Chair MacKinnon CLOSED public testimony.
Vice-Chair Bishop read FN1 from the Department of Commerce,
Community and Economic Development.
If the bill passes the division will require $4,500
for legal costs to amend regulations, printing, and
postage in the first year.
Professional licensing programs within the Division of
Corporations, Business and Professional Licensing are
funded by Receipt Supported Services, fund source 1156
Rcpt Svcs (DGF). Licensing fees for each occupation
are set per AS 08.01.065 so the total amount of
revenue collected approximately equals the
occupation's actual regulatory costs.
9:41:51 AM
Senator Dunleavy suggested that the money be taken from the
Board of Pharmacy budget which showed a carry-over of
$544,000, as opposed to General Fund money.
Co-Chair MacKinnon relayed that there was no General Fund
money in the item, that it was coming from designated fund
receipts, but that it could be more closely examined.
Co-Chair MacKinnon informed committee members that proposed
amendments were due the following Friday at 5:00 p.m.
Co-Chair MacKinnon discussed the schedule for the following
meeting.
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