Legislature(2017 - 2018)BUTROVICH 205
02/15/2017 01:30 PM Senate HEALTH & SOCIAL SERVICES
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| Audio | Topic |
|---|---|
| Start | |
| SB36 | |
| SB32 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| += | SB 36 | TELECONFERENCED | |
| + | TELECONFERENCED | ||
| += | SB 32 | TELECONFERENCED | |
SB 32-PRESCRIPTIONS FOR BIOLOGICAL PRODUCTS
1:58:35 PM
CHAIR WILSON called the committee back order. He announced the
consideration of SB 32. He summarized that the committee heard a
bill overview and had taken public testimony on February 10. He
asked that Senator Hughes, the bill sponsor, provide final
comments on SB 32.
1:59:06 PM
SENATOR SHELLEY HUGHES, Alaska State Legislature, Juneau,
Alaska, sponsor of SB 32, stated she was available to answer
questions.
SENATOR BEGICH noted that he received a letter from the Alaska
State Medical Association (ASMA) that indicated opposition to SB
32. He detailed that ASMA proclaimed that SB 32 was not as
permissive as it needed to be because biosimilars are perceived
by the FDA to be considerably safe.
SENATOR HUGHES replied that she was surprised by the ASMA letter
because she received an earlier letter from a physician who
requested notification and prior authorization. She remarked
that ASMA has indicated their belief that the FDA process and
approval of biosimilars for substitution at the "silver
standard" level would be fine versus the "gold standard" of
interchangeable. She opined that biosimilars are new and because
the FDA does plan to have additional criteria for the
interchangeable "gold standard," SB 32 should be left as is in
order to provide another level of safety. She set forth that a
prescriber needs to stay in the "driver's seat" with the ability
to write, "Dispense as written" or "Call if substitute
available".
SENATOR HUGHES detailed that the FDA criteria for
interchangeable is very strict:
1. The interchangeable first has to be classified as a
biosimilar.
2. The biosimilar must be expected to produce the same
clinical results as the original-biologic product in any
given patient.
3. The risk in terms of safety and efficacy of alternating or
switching between the use of an interchangeable and the
original biologic is not greater than the risk of continued
use of just the original biologic product.
2:02:45 PM
She noted health-care provider groups that announced their
support as follows:
· Every state medical society,
· The American College of Rheumatology,
· The National Medical Association,
· The American Association of Clinical Endocrinologists,
· The American Association of Neurological Surgeons,
· The American College of Mohs Surgery,
· Association of Black Cardiologists,
· American Society of Plastic Surgeons,
· The Congress of Neurological Surgeons,
· The National Hispanic Medical Association.
She emphasized that the list consisted of health-care providers,
not just patient-advocacy groups. She opined that the groups
looked hard at the legislation and the consensus language that
was reached seems to be appropriate. She reiterated that
maintaining the interchangeable "gold standard" is what's best
for Alaskans.
2:04:02 PM
CHAIR WILSON asked Senator Hughes to address a $4,500 Department
of Commerce, Community and Economic Development fiscal note for
the bill.
SENATOR HUGHES concurred that the fiscal was a little odd. She
remarked that she is not accustomed to departments that ask for
funding to write a minor set of regulations. She noted that the
fiscal note can be addressed in the Senator Labor and Commerce
Committee, the next committee of referral.
SENATOR GIESSEL pointed out that the fiscal note analysis was
referenced on page 2 of the fiscal note.
CHAIR WILSON asked if there were any amendments for SB 32.
2:05:33 PM
SENATOR GIESSEL offered Amendment 1:
30-LS0188\J.1
Bruce
2/14/17
AMENDMENT 1
OFFERED IN THE SENATE BY SENATOR GIESSEL
TO: SB 32
Page 2, line 17:
Delete "equivalent drug product or interchangeable biological
product"
Insert "(1) equivalent drug product; or
(2) interchangeable biological product after obtaining
authorization under (c) of this section"
Page 2, line 25, following "shall":
Insert ", before dispensing the interchangeable biological
product,"
Page 2, line 26:
Delete "biological product"
Insert "proposed biological product that may be"
Page 2, line 27, following "product":
Insert ", and obtain authorization from the prescribing
practitioner"
Page 2, lines 27 - 29:
Delete "The communication must be provided within three business
days after dispensing the biological product as follows:"
Insert "The communication may be provided as follows:"
Page 3, line 10, following "information":
Insert "to or obtain authorization from the prescribing
practitioner"
Page 3, line 19, following "information":
Insert "and obtain the authorization"
Page 3, lines 21 - 22:
Delete ", without the prescriber's expressed authorization,"
Page 3, line 23, following "(A)":
Insert "without the prescriber's expressed authorization,"
Page 3, line 25, following "(B)":
Insert "with the prescriber's authorization,"
2:05:40 PM
SENATOR VON IMHOF objected for discussion purposes.
2:06:14 PM
At ease.
2:06:42 PM
CHAIR WILSON called the committee back to order.
2:06:48 PM
JANE CONWAY, Staff, Senator Giessel, Alaska State Legislature,
Juneau, Alaska, summarized that Amendment 1 requires that
communication must be provided and authorization obtained from
the prescribing practitioner prior to dispensing the medication,
the interchangeable biological product. She explained the
changes as follows:
Page 2, line 17:
Page 2, line 17: adds "or interchangeable biological
product." It also adds "interchangeable biological
product after obtaining authorization" under "C" of
this section.
Page 2, line 25:
Following "shall", insert "before dispensing the
interchangeable biological product"; again, just
emphasizing that these things shall happen before the
dispensing of the product.
Page 2, line 26:
Deletes the words "biological product" and inserts
"proposed biological product that may be" dispensed.
Page 2, line 27:
Following "product", inserts the words "and obtain
authorization from the prescribing practitioner".
Page 2, lines 27-29:
Deletes the line, "The communication must be provided
within three business days after dispensing the
biological product as follows:", that whole line is
deleted and inserted instead is, "The communication
may be provided as follows:", and then it goes on to
show how those different communications can be done.
Page 3, line 10:
Following "information", inserts the words, "to or
obtain authorization from the prescribing
practitioner".
Page 3, line 19:
Following "information", inserts the words, "and
obtain the authorization".
Page 3, lines 21-22:
An error to a comma that was caught during the draft
of the amendment, delete "',' without the prescriber's
expressed authorization".
Page 3, line 23:
Following "(A)" inserts, "without the prescriber's
expressed authorization".
Page 3, line 25:
Following "(B)" inserts, "with the prescriber's
authorization".
All of these changes have to do with the intent of
that amendment to have all of the communication be
provided and authorized before the dispensing of the
drug.
2:10:32 PM
SENATOR GIESSEL spoke to Amendment 1 as follows:
We held public testimony on this bill last week. My
concern is that the testimony was solely from those
individuals who advocates for the bill. Oral history
last week had 7-national organizations advocating for
this bill and 4-local organizations, there was no
oppositional testimony. In the letters, written
documents, we have 16-national organizations
advocating and 1-local organization, and 2-local folks
are opposing this; those local folks were never heard
from, so I'm actually speaking on behalf of them, I'm
actually told that one of those local individuals who
wrote a letter was asked to withdraw her letter, that
concerns me.
The argument that's put forth in the most recent
document I received today, in fact an hour or so, came
from the Arthritis Foundation and I've heard this
argument before that such an amendment that I'm
offering would conflict with federal law, because the
federal law allows this without the substitution,
without intervention of the health-care provider, and
this is asserted to be a reason that the state of
Alaska cannot be more strict and I'm no lawyer, but I
contested that assertion. I believe state law can be
more restrictive than federal law, so I don't believe
that negates the amendment.
I'm a clinician, it has been asserted that if the FDA
approves this, it's got to be okay. I have heard from
specialists who use these medications that these are
unique proteins that act uniquely in each one of us in
a different way and that switching from one protein to
the other, in other words these allegedly
interchangeable products actually diminishes the
effectiveness of these unique proteins in the
individual's body, that concerns me.
The second thing that concerns me is FDA approval
being asserted as a "gold standard." About 15 years
ago, the Varivax vaccine was approved by the FDA, this
is a vaccination for children to prevent the
occurrence of chicken pox. I worked at a pediatric
clinic at that time and we gave one of the first
Varivax vaccines in this state; a week later that two-
year old came in and could no longer walk, his verbal
skills were significantly impaired, and he was having
a reaction to this Varivax vaccine. FDA does not mean
that there will not be adverse events; that sticks in
my mind as the question I always put behind someone
who says, "FDA approves it, it must be okay."
I also question, and I have heard from a pharmacist
that they are not sure they have a concern about this,
but I have concerns for the pharmacist's liability. So
the pharmacist is now making a decision to change this
very unique protein medication without discussion with
the clinician, change it to a different formulation.
So the clinician has the health records of this
individual, the clinician knows a lot about the
patient and he has chosen, he or she, has chosen this
unique protein medication, wonderful medications, and
now the pharmacist is unilaterally going to change
that without consultation with the clinician. I
contend that there's going to be a liability for that
pharmacist if there's an adverse outcome; that of
course can only be tested in a court of law, that's a
very expensive process.
So that's my reason for offering this amendment. I
don't believe this has to be rushed, I don't believe
this needs to be done without the team that makes up
health care: the clinician, the pharmacist, and the
patient, all consulting together for the best
outcomes.
2:15:27 PM
CHAIR WILSON asked if there was further objection to the
amendment.
SENATOR BEGICH announced that he objected to Amendment 1. He
explained his objection as follows:
As Senator Giessel duly noted in a duly noticed public
hearing that all of the proper, appropriate notice
required by law, a number of organizations testified
on this bill and anyone was able and had opportunity
to testify on this bill. We had testimony, as she
points out, that was overwhelmingly in favor of this
legislation.
I also take note of some of the comments from the
Arthritis Foundation, which I also received today and
would note that there's a question here of the
amendment proposed potentially delaying prescription
service, but I want to go further and since we are
talking about personal stories, a member of my own
staff is a beneficiary of these products. My staffer
who is in the audience, Richard Benavides, suffers
from cancer, uses these and has identified to me that
the ability to have rapid access to what are known to
be safe procedures is something that he finds is
essential to his wellbeing.
I would argue that our duty here is to allow a public
process and then through that public process, adjust
if necessary a bill. We have done that public process,
the testimony overwhelmingly favored the bill as is or
in fact moves in the opposite direction of what
Senator Giessel is proposing. We will have further
committees and there will be further opportunity, but
at this time I just want to express my objection to
that amendment and would urge the members to not
support this amendment.
2:17:56 PM
SENATOR GIESSEL clarified that public testimony did not allow
opposition. She set forth that the individuals who opposed the
bill were online and were not allowed to testify because the
meeting ran out and public testimony was closed; consequently,
their voice was not heard. She explained that Amendment 1 does
not limit access to biologics in any way. She specified that the
interchangeables, which are addressed in the bill, are not yet
available and may not be available for several years. She asked
what the rush is.
CHAIR WILSON noted for the record that some of the comments for
and against were publicized and made available on the internet
for folks to see.
SENATOR VON IMHOF commented on Amendment 1 as follows:
I very much appreciate the robust dialogue and thank
you Senator Giessel, you brought up actually some
interesting points that gave me pause today and made
me think, it's interesting trying to digest the
information that comes in associated with all of these
bills, both in the written form and in the verbal
form. As we sit here, I feel that it is best to try
to, again, to use my words I said in the previous
bill, thread-the-needle and try to find the best-foot-
forward based on the information that we have in front
of us.
I understand the concern with the FDA, I don't share
those same concerns; I believe that it is a very
robust and successful entity and that their analysis
gives me comfort. I also see in the letter we received
today that biosimilars have been used in Europe with
excellent safety and efficacy profile since 2006, and
have resulted in significant cost savings. Health-care
costs in Alaska is a significant issue as we can all
attest and if there's no clinical, meaningful
differences between biologic and the reference
biological in terms of safety, purity and potency, yet
it provides a cost difference, then I think it makes
sense to go forward with this.
I understand that there are no biosimilars on the
market now, but yes it could be years from now, or it
could be months from now, we don't know. So as a good
boy scout it's best to be prepared. I'm going to vote
for the pure form of this bill and not support the
amendment.
2:21:40 PM
A roll call vote was taken. Senator Giessel and Chair Wilson
voted in favor of Amendment 1; Senators Begich and von Imhof
voted against it. Therefore, Amendment 1 failed by a 2:2 vote.
CHAIR WILSON announced that hearing no further amendments, he
would entertain a motion to move SB 32 out of committee.
2:21:53 PM
SENATOR VON IMHOF moved to report SB 32, [30-LD0188\J], from
committee with individual recommendations and attached fiscal
note(s)
2:22:03 PM
CHAIR WILSON announced that without objection, SB 32 moved from
Senate Health and Social Services Standing Committee.
2:22:12 PM
SENATOR GIESSEL commented as follows:
Before we leave this subject, you know there's a
reason that Senator von Imhof is on the finance
committee. She has expertise in that area. There's a
reason that I am on the health committee. I'm a
clinician. I appreciate the discussion today, thank
you.
| Document Name | Date/Time | Subjects |
|---|---|---|
| ASPS Comments - Scope Optometric - AK SB36 - 02-13-2017.pdf |
SHSS 2/15/2017 1:30:00 PM |
SB 36 |
| Carmen Moore - oppose.pdf |
SHSS 2/15/2017 1:30:00 PM |
SB 36 |
| Drug schedules - Giessel.pdf |
SHSS 2/15/2017 1:30:00 PM |
SB 36 |
| New Mexico House Business & Industry Committee Letter 2007.pdf |
SHSS 2/15/2017 1:30:00 PM |
SB 36 |
| SB 32 Legislation - Version J.pdf |
HHSS 4/13/2017 3:00:00 PM SHSS 2/10/2017 1:30:00 PM SHSS 2/15/2017 1:30:00 PM |
SB 32 |
| SB 36 ASMA oppose.pdf |
SHSS 2/15/2017 1:30:00 PM |
SB 36 |
| Alaska Biosimilars Arth Fdn oppose amendment sb 32.pdf |
HHSS 4/13/2017 3:00:00 PM SHSS 2/15/2017 1:30:00 PM |
SB 32 |
| SB32 - Clarification on Questions Asked in the Committee (Sen Hughes).doc |
HHSS 4/13/2017 3:00:00 PM SHSS 2/15/2017 1:30:00 PM |
SB 32 |
| SB32_ASMA.pdf |
HHSS 4/13/2017 3:00:00 PM SHSS 2/15/2017 1:30:00 PM |
SB 32 |
| SB 32 Am No. 1.PDF |
SHSS 2/15/2017 1:30:00 PM |
SB 32 |