Legislature(2017 - 2018)BELTZ 105 (TSBldg)
04/04/2017 09:00 AM Senate LABOR & COMMERCE
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| Audio | Topic |
|---|---|
| Start | |
| Confirmation Hearings | |
| SB51 | |
| SB93 | |
| SB98 | |
| SB37 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| + | TELECONFERENCED | ||
| += | SB 51 | TELECONFERENCED | |
| += | SB 93 | TELECONFERENCED | |
| += | SB 98 | TELECONFERENCED | |
| += | SB 37 | TELECONFERENCED | |
| += | SB 79 | TELECONFERENCED | |
| + | TELECONFERENCED |
SB 37-PHARMA BD & EMPLOYEES;DRUG DIST/MANUFAC
9:36:07 AM
CHAIR COSTELLO reconvened the meeting and announced the
consideration of SB 37. She advised that this is the second
hearing, public testimony is open, and there is a proposed
committee substitute (CS).
9:36:23 AM
SENATOR MEYER moved to adopt the work draft CS for SB 51,
labeled 30-LS0191\J, as the working document.
CHAIR COSTELLO objected for an explanation of the changes.
9:36:43 AM
WESTON EILER, Staff, Senate Labor and Commerce Committee, Alaska
State Legislature, said the changes in the CS for SB 37, version
J, primarily removes references to establishing a range 23
executive position that would serve as a legislative
liaison/administrator position for the board. He listed the
three places where the reference is deleted.
9:38:32 AM
SENATOR GARDNER questioned how the record-keeping and follow-up
for inspection of facilities outside the state would happen
without that position.
MR. EILER said this likely would not be a position that would do
those site visits. The policy call to remove this position
reflects DCCED's budgetary constraints and could be reviewed at
a later date.
SENATOR GARDNER asked who is expected to do this administrative
work and where the funding is if the work is done by contract.
MR. EILER said licensing fees and inspections of facilities
outside the state will bring in additional revenues. The
department can speak to the structure, but the inspections don't
necessarily fall to the staff of the Board of Pharmacy.
SENATOR GARDNER asked if the board has the flexibility to set
the licensing fees at the appropriate level to cover contractual
work.
MR. EILER said his understanding is that the bill provides for
that.
9:41:39 AM
SARA CHAMBERS, Division Operations Manager, Division of
Corporations, Businesses and Professional Licensing, Department
of Commerce, Community and Economic Development (DCCED), stated
that the need for executive staff to handle the federal policy
changes has pushed the need for higher level staff over the
tipping point. SB 37 reflects an additional need the board has
expressed to comply with federal changes. Right now, this
program has one staff member who is the licensing examiner and
has fractions of management that is shared among 42 other
licensing programs. Thus, there is no policy position that is
assigned to this program, which puts Alaska at a disadvantage
among states that do have an executive administrator. The
position would be paid through receipt-supported services, so it
is not supported by UGF in any way. There is a growing interest
in managing opioids and the PDMP and this position would oversee
all those responsibilities as well. It would fill quite a
variety of needs beyond a liaison to the legislature and it's a
position that is desperately needed, she said.
SENATOR GARDNER summarized that the board has the authority to
raise the licensing fees to cover the cost of complying with the
federal requirements of licensing facilities and dealing with
the requirements of PDMP and the opioid crisis.
MS. CHAMBERS clarified that the division works with the board to
set fees. She said the fiscal note includes the cost of an
executive administrator, but it does not contemplate the
additional receipt authority needed for a contract position.
CHAIR COSTELLO noted that the original bill says the duties will
be established. She asked Ms. Chambers how she already knows
what the position would entail.
MS. CHAMBERS said that knowledge is based on the administrative
functions that existing boards such as medicine, public
accountancy, nursing, and marine pilots perform, and this
position proposes to do. "We know the existing needs and we know
what the bill will entail to implement." The division would
employ the executive administrator and work with the board to
make certain that all its priorities and the statutory
administrative priorities are met.
9:47:03 AM
SENATOR MEYER asked if pharmacy receipt increases are passed
along to the consumer. "Is this kind of a hidden tax on our
prescriptions?"
MS. CHAMBERS explained that all 43 licensing programs are paid
for by receipts. "Whether you're getting your hair cut, whether
you're vising the doctor, whether you're getting a house built,
that's a business decision that those professionals make on how
they recoup their licensing costs. But it is not unusual in how
statute mandates these programs be paid for."
SENATOR MEYER asked if this legislation is modeled on other
states.
MS. CHAMBERS said yes, it's an outgrowth of a need the federal
government expressed after 2012 and compounded by the pharmacy
crisis. All but six states have adopted similar legislation.
SENATOR MEYER asked if out of state distributors will be
assessed a licensing fee should the bill pass.
MS. CHAMBERS said only instate wholesale distributors are
licensed so there is currently a disparity between instate and
out-of-state. Should the bill pass, the division will develop a
licensing process and an associated fee to help offset the cost
of running the program.
CHAIR COSTELLO listed the individuals available to answer
questions.
SENATOR STEVENS questioned the need for the bill if these out-
of-state facilities are already licensed and inspected by
another state or the federal government. Concerning reciprocity,
he asked if the intention is to automatically license any
facility that already has an inspection by another state or the
federal government.
9:50:02 AM
MS. CHAMBERS deferred the question to Leif Holm or Richard Holt.
9:50:13 AM
LEIF HOLM, Chair, Board of Pharmacy, Fairbanks, Alaska, said
this bill is needed to protect consumers from counterfeit or
increased costs due to diverted medications. He said Alaska is
one of four states that does not license outside wholesalers and
that presents a problem. A wholesaler that is licensed in
another state and doing business in Alaska would follow that
other state's laws, but not necessarily the rules and
regulations that Alaska has established. This could provide an
opportunity for diverters and counterfeiters to exploit Alaska.
"We don't have requirements for transaction data history; we
don't have requirements for inspections; we don't have any
accountability or oversight and it's basically decreasing the
confidence in our drug supply."
SENATOR STEVENS asked for confirmation that a drug distributor
or outsourcing facility that is licensed in another state would
not automatically receive a license to operate in Alaska.
MR. HOLM said that's correct; a wholesaler would not
automatically be granted a license to operate in Alaska based on
licensure in another state. Rather, the board would write
regulations for wholesalers to follow based on FDA guidelines.
The intent is to require inspections, but the board would accept
outside third-party inspections upon review.
SENATOR STEVENS asked how many facilities will be licensed in
Alaska.
MR. HOLM said a recent National Association of Boards of
Pharmacy (NABP) presentation stated that about 1,163 wholesale
distributers are licensed in other states. and could potentially
be licensed in Alaska. If each of those paid $500 to apply for
licensure in Alaska, that would generate just under $600,000.
9:54:43 AM
SENATOR GARDNER asked, should the original bill pass: 1) if he
anticipates that Alaska would establish some sort of
reciprocity; and 2) the number of licensed distributers that
would want to participate in Alaska's licensing process.
MR. HOLM said most facilities accept that they must have a
license from any state in which they operate. The executive
administer position would help make the process more fluid, but
he didn't have an estimate for the number of distributors that
would apply for licensure. He reiterated that 46 other states
have passed similar legislation with no reported issues.
SENATOR GARDNER asked how it would be possible to move forward
if the committee substitute were to pass with the requirement
but no funding for the position to handle the licensing.
MR. HOLM said it would be difficult for the one existing
licensing examiner to handle 1,100 additional licenses.
CHAIR COSTELLO asked what impact the increased fees would have
on licensed pharmacists.
MR. HOLM replied there probably would not be any licensing fee
increase for pharmacists. Should wholesalers be licenses, that
would be more than enough to cover any extra costs.
9:58:35 AM
CHAIR COSTELLO stated that, based on the testimony today, she
would hold SB 37 and continue to work with the sponsor.
| Document Name | Date/Time | Subjects |
|---|---|---|
| CS SB 37 (L&C) - Ver. J.pdf |
SL&C 4/4/2017 9:00:00 AM |
SB 37 |
| SB 51 - Support Letter - State Veterinarian Dr Gerlach.pdf |
SL&C 4/4/2017 9:00:00 AM |
SB 51 |
| CS SB 51 (L&C) - Ver. O.pdf |
SL&C 4/4/2017 9:00:00 AM |
SB 51 |