04/07/2017 03:15 PM House LABOR & COMMERCE
| Audio | Topic |
|---|---|
| Start | |
| HB9 | |
| Adjourn |
+ teleconferenced
= bill was previously heard/scheduled
| *+ | HB 9 | TELECONFERENCED | |
| + | TELECONFERENCED | ||
| += | HB 124 | TELECONFERENCED | |
ALASKA STATE LEGISLATURE
HOUSE LABOR AND COMMERCE STANDING COMMITTEE
April 7, 2017
3:17 p.m.
MEMBERS PRESENT
Representative Sam Kito, Chair
Representative Adam Wool, Vice Chair
Representative Andy Josephson
Representative Louise Stutes
Representative Chris Birch
Representative Gary Knopp
Representative Colleen Sullivan-Leonard
MEMBERS ABSENT
Representative Mike Chenault (alternate)
Representative Bryce Edgmon (alternate)
COMMITTEE CALENDAR
HOUSE BILL NO. 9
"An Act relating to the Board of Pharmacy; relating to the
licensing and inspection of certain facilities located outside
the state; relating to drug supply chain security; and creating
a position of executive administrator for the Board of
Pharmacy."
- HEARD & HELD
HOUSE BILL NO. 124
"An Act relating to corporations, including benefit
corporations, and other entities; and providing for an effective
date."
- SCHEDULED BUT NOT HEARD
PREVIOUS COMMITTEE ACTION
BILL: HB 9
SHORT TITLE: PHARMA BD & EMPLOYEES; DRUG DIST/MANUFAC
SPONSOR(s): REPRESENTATIVE(s) SADDLER
01/18/17 (H) PREFILE RELEASED 1/9/17
01/18/17 (H) READ THE FIRST TIME - REFERRALS
01/18/17 (H) L&C, FIN
04/07/17 (H) L&C AT 3:15 PM BARNES 124
WITNESS REGISTER
REPRESENTATIVE DAN SADDLER
Alaska State Legislature
Juneau, Alaska
POSITION STATEMENT: As the sponsor, introduced HB 9.
LEIF HOLM, PharmD, Master of Public Health (MPH)
Chair, Board of Pharmacy
North Pole, Alaska
POSITION STATEMENT: Testified in support of HB 9.
DIRK WHITE, Pharmacist
Sitka, Alaska
POSITION STATEMENT: Testified in support of HB 9.
BARRY CHRISTENSEN, Registered Pharmacist (RPh)
Co-Chair, Legislative Committee
Alaska Pharmacists Association
Ketchikan, Alaska
POSITION STATEMENT: Testified in support of HB 9.
DELLA CUTCHINS, Pharmacist
President, Alaska Pharmacists Association
Anchorage, Alaska
POSITION STATEMENT: Testified in support of HB 9.
SCOTT WATTS, Pharmacist
Juneau, Alaska
POSITION STATEMENT: Testified in support of HB 9.
ACTION NARRATIVE
3:17:11 PM
CHAIR SAM KITO called the House Labor and Commerce Standing
Committee meeting to order at 3:17 p.m. Representatives Kito,
Sullivan-Leonard, Stutes, Knopp, Birch, Josephson, and Wool were
present at the call to order.
HB 9-PHARMA BD & EMPLOYEES; DRUG DIST/MANUFAC
3:17:50 PM
CHAIR KITO announced that the first order of business would be
HOUSE BILL NO. 9, "An Act relating to the Board of Pharmacy;
relating to the licensing and inspection of certain facilities
located outside the state; relating to drug supply chain
security; and creating a position of executive administrator for
the Board of Pharmacy."
3:18:42 PM
REPRESENTATIVE WOOL moved that the committee adopt the proposed
committee substitute (CS) for HB 9, Version 30-LS0131\J, Bruce,
4/6/17, as the working document. There being no objection,
Version J was before the committee.
3:19:04 PM
REPRESENTATIVE DAN SADDLER, Alaska State Legislature, sponsor,
explained that HB 9 is about strengthening the integrity of
Alaska's prescription drug supply chain. It would do so by
making Alaska comply with the federal Drug Quality and Security
Act (DQSA) of 2013. Alaska is one of the last states to adopt
this and comply, he pointed out, and if Alaska doesn't do this
itself the federal government will do it for the state. He said
the bill would give Alaska's Board of Pharmacy the authority to
license and inspect three kinds of facilities: out of state
wholesale drug distributors; third party logistics providers,
which are people who coordinate shipping or warehousing of
pharmaceuticals but they don't actually own the drugs or direct
the sale; and outsourcing facilities that ship pharmaceuticals
to Alaska, which are places that might compound or create
sterile drugs in one place for delivery to another.
REPRESENTATIVE SADDLER stated that to accomplish this compliance
goal, HB 9 would create a new category of pharmacy license that
covers all three of the aforementioned facilities. It is called
an out of state wholesale or distributor license. The bill
would require that any out of state wholesale drug distributor,
third party logistics provider, or outsourcing facility hoping
to work in Alaska obtain this out of state license. The bill
would authorize the Board of Pharmacy to inspect each facility
or to have an inspection done by somebody designated by the
board, he continued. The bill would require such facilities to
appoint an agent in Alaska before it advertises its services or
ships drugs to Alaska. He noted that to help implement these
changes, HB 9 would also authorize the Board of Pharmacy to
create a new position of executive administrator. The person
holding this position would help manage the workload to meet
this federal act and other increasing Federal Drug
Administration (FDA) regulations, he said. The administrator
would also help manage the current licensing burden and serve as
a liaison to the legislature, the executive branches of other
states, and the pharmacy boards of other states.
REPRESENTATIVE SADDLER advised that the risks of failing to
comply with this federal act and provide these protections for
Alaska's drug chain are tremendous and fatal. The case study of
the need for doing this, he said, is the 2012 national outbreak
of fungal meningitis that infected 751 people in 20 states, of
which 64 people died. The investigators after the fact traced
the cause to a compounding facility in Massachusetts, which was
producing medication in unsanitary conditions and shipping the
medications across the country.
REPRESENTATIVE SADDLER summarized by saying that HB 9 would give
the State of Alaska and its Board of Pharmacy the tools to
ensure that Alaskans get safe, controlled, non-counterfeit
medications. The bill would close loopholes in the regulatory
system and would apply the same regulations that wholesalers
shipping drugs within the state must follow to those importing
drugs from out of the state.
3:22:33 PM
REPRESENTATIVE BIRCH inquired whether HB 9 would apply just to
the drugs that are behind a pharmacy counter or would also apply
to those drugs in front of the counter.
REPRESENTATIVE SADDLER replied it would apply to prescription
medications, not over the counter drugs such as pre-packaged
ibuprofen.
3:23:10 PM
REPRESENTATIVE KNOPP asked whether he is correct in
understanding that HB 9 would provide for the inspecting and
licensing of facilities that are out of state. He further asked
whether there would be anything in the state.
REPRESENTATIVE SADDLER responded that currently the state does
inspect the one wholesale distributor located in state. The
bill envisions the inspecting of some 400 facilities that meet
those three definitions that would be doing business in Alaska.
As for the actual inspections and standards and what the
inspections would consist of, he deferred an answer to one of
the experts on the Board of Pharmacy. He noted that HB 9 has an
effective date of 2018 for the regulations to take place. He
added that the effective date for the executive administrator
would be immediate because there is a backlog of work that needs
to be done as well as a fair amount of work that needs to be
done in advance of these inspections.
REPRESENTATIVE KNOPP offered his understanding that if HB 9 is
not adopted the federal government would impose regulations.
REPRESENTATIVE SADDLER addressed the question of what happens if
Alaska does not do this. Some folks, he related, have said that
other states within which a compounding facility is located
might have their own standards and the State of Alaska might
save money by adhering to and trusting those standards.
However, as seen by the case study about meningitis, he advised,
it might not be to the best interests of Alaskans to trust some
other place. He deferred to Dr. Leif Holm, chair of the Board
of Pharmacy, to further answer the question regarding what would
happen if the federal government were to take over.
3:25:44 PM
REPRESENTATIVE JOSEPHSON stated he likes HB 9 but needs to
understand it better. Regarding drug manufacturers in the Lower
48, he inquired whether there are 48 states that send an
investigator to the same factory to inspect the facility. He
said it seems odd that everyone would be doing this.
REPRESENTATIVE SADDLER allowed that it does seem redundant and
he isn't sure whether that actually is the situation. There are
some standards that a facility in any location meets, he said,
and it would receive that certification and that would be good
for all the other states. Some facilities serve so many states
that, yes, it is important to do that. He deferred to Dr. Holm
to further answer the question.
3:26:44 PM
REPRESENTATIVE WOOL offered his understanding that it is a
supply chain that is being talked about. He said he is unsure
how many stops a pill makes from the time it is fabricated until
the time it is in the pharmacy. He surmised that the inspection
point is what is being questioned; for example, food products
are inspected by the FDA and then distributed to many states and
he expects that this would be the same for a drug product. He
said he is therefore confused as to why every state would send
an inspector to a particular facility.
REPRESENTATIVE SADDLER deferred to those who deal with the
pills to provide an answer.
3:27:42 PM
CHAIR KITO inquired whether a PowerPoint presentation is going
to be provided by the sponsor.
REPRESENTATIVE SADDLER replied that [six slides in a PowerPoint
presentation, entitled "SB 37 & HB 9: Why license wholesale
drug distributors?"] are included in the committee packet, but
that he doesn't plan to provide them as an audio-visual
presentation.
3:28:10 PM
LEIF HOLM, PharmD, Master of Public Health (MPH), Chair, Board
of Pharmacy, testified in support of HB 9. He said the bill is
important on many fronts for the board's utmost concerns for the
safety of the state's patients. Alaska is one of the last
states in the union attempting to fill the requirements of the
DQSA that manage licensing of wholesale drug distributors and
503B outsourcing facilities. He pointed out that it's important
to license out of state entities so that Alaska, as a state, has
a better control and an increased confidence in its drug supply.
The control would develop and maintain standards for Alaska
facilities doing business in the state and there would be
confidence that medications provided to Alaskan patients are of
the highest quality and not counterfeit medications.
DR. HOLM stated that of equal importance to the Board of
Pharmacy is the executive administrator position included in the
bill. As proposed, he explained, this position would serve as a
liaison to the legislature and to other state boards of
pharmacy, as well as assisting the current full-time examiner
position's licensing duties. With the ever-increasing amount of
pharmacy issues and their complexity, he continued, the Board of
Pharmacy is already falling behind with regard to regulation
standards amongst other states and the board will only fall
farther behind without additional assistance. Licensing is on
the rise at a rapid pace due to out of state pharmacies being
licensed and having a single licensing examiner to oversee this
is no longer reasonable or very effective. This burden is only
going to increase with the request that [the Board of Pharmacy]
begin licensing out of state wholesalers and outsourcing
facilities. The bill is much needed and long overdue, he
emphasized, and the Board of Pharmacy is in full support of the
current form.
3:29:53 PM
REPRESENTATIVE JOSEPHSON noted that legislators have REAL ID on
their minds and have been told about things that could happen to
Alaska soon if it doesn't pass REAL ID. He asked what would
happen if Alaska didn't comply with the federal law in question.
DR. HOLM replied that the federal government would come in and
license. An issue with that is that there is no procedure in
place for the federal government to do that, and this is widely
understood by the organizations that are involved with this,
such as the National Association of Boards of Pharmacy (NABP)
and the National Community Pharmacy Association (NCPA). He said
it is believed that the federal government is ill equipped to do
it since it would be a new licensing procedure for them. With
most states already licensing their instate and out-of-state
wholesalers it is believed that this is really a back-burner
thing for the FDA and the federal government and that they might
not in a very timely fashion proceed with any type of licensing.
In the meantime, he continued, [the Board of Pharmacy] has no
oversight and even if [facilities] are licensed in another
state, if [the Board of Pharmacy] doesn't license them then the
board has no jurisdiction. He advised that it would open the
floodgates for [Alaska] having no system controls in place and
wholesalers can work and operate in Alaska in any way they want
and [the Board of Pharmacy] has no authority to inspect them or
even monitor an inspection or require that they operate in a
certain way. They can basically do whatever they want and [the
Board of Pharmacy] ends up where it is now, which is questioning
if there are counterfeit drugs in Alaska and drugs diverted in
Alaska. He said this is unknown because [the board] allows them
to operate without a license.
3:31:43 PM
REPRESENTATIVE KNOPP asked how many out of state wholesalers and
facilities would be inspected, what would be the frequency of
inspections, and whether there would be a requirement timeframe
for frequency and quantity.
DR. HOLM responded that there is a misunderstanding that [the
Board of Pharmacy] is going to inspect these facilities, which
is an option, but not a requirement. The intent is that [the
board] would require that they be inspected. There are national
third-party inspectors where they can become certified through a
verified wholesale inspection through the NABP. It is quite
expensive for these states to do, he said, but once they
complete it, most states recognize that as a quality inspection
and that the facility is a quality operating facility. So, he
reiterated, [the Board of Pharmacy] wouldn't necessarily be
inspecting all the facilities, the number of which he believes
to be just fewer than 1,200 wholesale distributors licensed in
each individual state. [The Board of Pharmacy] would not
physically fly someone down to inspect 1,200 different wholesale
distributors. The board would be monitoring them as a board as
they came in through a licensing application and monitoring
whether they did what the board deems is an appropriate
inspection. The board would then have access to monitor and
look at the inspection to see if it is acceptable by the state's
standards.
3:33:35 PM
REPRESENTATIVE WOOL remarked he is unfamiliar with how the
pharmaceutical industry works. He inquired as to what point in
the supply chain the Board of Pharmacy would be inspecting. For
example, whether it would be where the drugs are being made or
the wholesale distribution. He further inquired as to what
exactly would be inspected given Mr. Holm is talking about
inspecting licenses. He surmised the thrust of the bill is to
prevent counterfeit drugs from coming into Alaska or improper
compounding. He requested Mr. Holm to walk the committee
through the supply line of a pharmaceutical; for example, if it
is produced overseas whether it comes to a wholesaler or
distributor or pharmacy in the U.S.
DR. HOLM answered that a manufacturer sells to wholesale
distributors, and most of the major wholesale distributors are
large corporations that do a large percentage of the medications
that are brought into every state. However, he continued, there
are a lot of secondary wholesalers and pharmacies that operate
under less than good standards in what is called a grey market.
They purchase large amounts of medication through wholesalers
that are outside of a normal supply chain and [these
wholesalers] procure the drug through an illegal means or
produce the drug in a counterfeit form. These secondary
wholesalers purchase these medications from these counterfeit
manufacturers and sell them to pharmacies that don't necessarily
know where the origin of the drug came from. The licensing
procedure under HB 9 would require a transaction history.
Currently a transaction history is not required, so [the Board
of Pharmacy] has no authority to look at where a drug came from
each step of the way.
DR. HOLM added that it is a very confusing procedure where
someone gets these medications. [The Board of Pharmacy] cannot
inspect the facility, so it could be that a wholesaler is
operating out of his or her house and could be procuring common
drugs through a diverted means. There is counterfeiting going
on with Medicaid, he noted. Patients will get numerous drugs
under Medicaid and when they don't need the drugs, they will
resell them to wholesalers who will then hold on to the drugs
until they can find a very high-priced market for them and then
release them into the supply chain. That would be a diversion
tactic.
3:37:26 PM
The committee took a brief at-ease.
3:38:45 PM
DR. HOLM addressed the PowerPoint slides in the committee packet
to further continue his answer to Representative Wool. He drew
attention to the fifth slide entitled, "Trail of Counterfeit
Avastin," and said it provides a good representation of what the
Board of Pharmacy is trying to get at with HB 9. He explained
that the trail begins when clinics order a medication, a
middleman procures the medication from an unknown supplier, and
that supplier then supplies the medication to the various
clinics that have ordered it. Most affected are physicians'
offices that don't order from the larger and more reputable
wholesaler manufacturers and instead order from the cheapest
place they can find. There are a lot of secondary wholesalers,
he continued, 1,200 that are licensed within the states. So,
physicians are ordering from all sorts of places and it is not
known where those drugs are coming from. He pointed out on the
slide that the counterfeit Avastin ended up in numerous U.S.
clinics where medications were needed for cancer.
REPRESENTATIVE SADDLER added that while people might have in
mind the idea that there is a manufacturer, a wholesaler, the
retail seller, and then the customer, slide 5 shows that drugs
may go through a convoluted chain of custody, and over time and
the course of many transactions the trail can be lost so that it
is unknown where a drug came from and whether it is a legitimate
original drug. Under HB 9, he said, the licensing would require
a chain of custody so that each time a drug was shipped from one
place to another there would be documentation, thereby providing
a chain of accountability all the way back to the manufacturer.
3:41:34 PM
REPRESENTATIVE SULLIVAN-LEONARD requested an overview of what
the sponsor foresees as the duties and oversight of the proposed
executive administrator position.
REPRESENTATIVE SADDLER replied that HB 9 proposes a high-level
position at range 23. The position would be paid for out of
increasing the license fees that would be assessed to the out-
of-state wholesalers, he emphasized. The administrator would
assist the Board of Pharmacy in ensuring that whoever is
providing drugs will have that licensure in effect. The
administrator would coordinate with other state legislatures,
executive agencies, and pharmacy boards to verify inspections.
The administrator would process the applications for licensure
that are received by the Board of Pharmacy. Representative
Saddler estimated that about 400 facilities would be applying
for this licensure, which would require a fair amount of
paperwork and coordination. As it stands now with the amount of
work required under the different [federal] healthcare mandates,
the current staff person to the Board of Pharmacy is overwhelmed
and the workload is weeks and months behind schedule. The
executive administrator would primarily help with implementation
of HB 9, he said, but would also help with other things.
3:43:12 PM
REPRESENTATIVE JOSEPHSON offered his understanding that HB 9
would only affect prescriptions, not over the counter drugs.
REPRESENTATIVE SADDLER responded correct.
REPRESENTATIVE JOSEPHSON surmised that a drug store pharmacist
would be able to say from what location the drug was obtained,
but that going any farther back would run into a brick wall.
REPRESENTATIVE SADDLER answered that in essence, it would get
foggy - where a person might assume good will but couldn't
verify it. Unless dealing with a very short chain, a person
doesn't know how many transactions have happened.
3:44:00 PM
CHAIR KITO returned to the PowerPoint slides and brought
attention to the fourth slide entitled, "What Do Counterfeit
Drugs Look Like? They are hard to detect!" He pointed out that
the photograph compares an authentic versus counterfeit [tablet
of Tamiflu].
DR. HOLM explained that he owns independent pharmacies and
through day-to-day business his pharmacies are constantly on the
lookout for positive reimbursement in medications. He said he
deals with 6-10 secondary wholesalers daily that he is fairly
certain are operating under good circumstances. However, he
doesn't know that for sure because they are not licensed by the
state of Alaska and so he tries to use them as minimally as
possible. For the times that he needs to use a secondary
wholesaler, he continued, he would like to know that Alaska is
being responsible in licensing them and knowing as a pharmacist
that in day-to-day business any wholesaler that he might come
across within his state has been vetted by his state. But right
now, he reiterated, he does not know that.
3:45:30 PM
REPRESENTATIVE JOSEPHSON inquired whether the counterfeits are
normally benign placebos or are harmful.
DR. HOLM offered his understanding that they are generally sugar
and are non-harmful, non-medicated, and no active drugs within
them. He related that about 150 countries manufacture the drugs
coming into the U.S.; 40 percent of the total drug supply is
manufactured out of country; and 80 percent of all the active
ingredients are manufactured out of country.
REPRESENTATIVE SADDLER added that the motivation for fraud is
tremendous. Everyone has heard horror stories of $500 per pill
or $40,000 a month for injectable cancer treatments. Bad actors
receive inexpensive placebos or contaminated drugs and pass them
on to end-user pharmacy clients, pocketing the money and not
caring that the results could be fatal or damaging to the
patient. Every country has bad actors and given how many
trillions of dollars the pharmaceutical business represents,
there is powerful motivation to take advantage of weaknesses.
If Alaska is the last state that has this protection, he
advised, then those bad actors are going to migrate to Alaska
and take advantage of the state's low threshold of safety.
3:47:31 PM
REPRESENTATIVE BIRCH asked whether the supply chain is looked at
through such things as radio-frequency identification (RFID)
tags. He surmised there would be some sort of tracking
mechanism for some drugs more than others.
REPRESENTATIVE SADDLER replied that there might be such, but he
is unsure. He deferred to Dr. Holm to provide an answer.
DR. HOLM stated he is unfamiliar with RFIDs.
CHAIR KITO explained that it is a radio-frequency tag associated
or affiliated with a batch that was manufactured.
DR. HOLM responded that the [2013] federal Drug Supply Chain
Security Act (DSCSA) intends that by the year 2023 a Quick
Response Code (QR Code) be placed on medication bottles. By
scanning this code, he explained, the entire history of that
bottle of medication will be seen from start to finish, but that
currently there is no capability to do this.
3:49:50 PM
DIRK WHITE, Pharmacist, testified in support of HB 9. He noted
he is the Past President of the Board of Pharmacy, and Past
President of the Alaska Pharmacists Association, and stated that
Dr. Holm's father was on the Board of Pharmacy when it
originally started working on this issue about five years ago.
He urged that HB 9 be passed for the health and safety of
Alaska's citizens. Had such a bill been passed, he advised, it
is possible that the New England Compounding Center, which
produced the contaminated injectable steroid that killed about
300 people and maimed 1,000 more, would have been caught. Had
the center been inspected on a regular basis, he continued, it
would have been caught and would have prevented the loss of life
and loss of quality of life.
MR. WHITE addressed the question about the pedigree of
medications and chain of custody. He pointed out that without
that pedigree on a medication and the chain of custody that
comes with it, he becomes liable for anything that might go
wrong. [Alaska] doesn't have anything that verifies that a
wholesaler, from which [pharmacies] are buying, is qualified to
provide the medications. He pointed out that parameters are
associated with medications, such as the need to be kept at a
certain temperature and humidity while stored for large
quantities of time. Parameters that are looked at in an
inspection include whether a medication needs refrigeration and
remains constantly refrigerated throughout its life from
manufacturer to wholesaler to secondary wholesaler to pharmacy.
The pedigree includes whether a medication has been kept
correctly, shipped correctly, or diverted somehow, and without
that pedigree none of this is known, he said.
MR. WHITE noted that RFID tracking was looked at years ago for
putting the tags all the way down to the tablets. However, no
one was able to come up with a tag that was compatible with the
FDA requirement, he advised, so [the FDA] will probably stick
with the QR Code, which can be scanned to pop up much of the
pedigree. He urged that HB 9 be passed.
3:53:31 PM
BARRY CHRISTENSEN, Registered Pharmacist (RPh), Co-Chair,
Legislative Committee, Alaska Pharmacists Association, testified
in support of HB 9. He said moving this legislation forward has
been the number one priority for his association for several
years. He stated he won't repeat what was said by Dr. Holm and
Mr. White but added that pharmacists like himself need to be
able to go to the Alaska statewide website and see that the
medications they are buying or contemplating to buy are coming
from a verified source. There is a need to create the executive
administrator position, he continued, to help the board and
ensure it can do its current job as well as the additional
strains of this legislation as well as several other bills. He
urged the passage of HB 9.
3:55:04 PM
CHAIR KITO opened public testimony on HB 9.
3:55:22 PM
DELLA CUTCHINS, Pharmacist, President, Alaska Pharmacists
Association, testified in support of HB 9. She said the bill is
vital to bring the state into compliance with federal
requirements that all wholesalers distributing prescription
drugs in Alaska be licensed. The Alaska Pharmacists Association
represents over 250 pharmacists and pharmacy technicians in
Alaska, she noted. The association's mission is to preserve,
promote, and lead the profession of pharmacy in Alaska, and HB 9
strongly aligns with that mission, as it will ensure that Alaska
is in line with the FDA mandate. She reiterated the
association's support of HB 9.
3:56:30 PM
REPRESENTATIVE WOOL recalled it being mentioned that if Alaska
doesn't do anything the federal government will come in and
regulate. He asked if that has happened in any other state.
MS. CUTCHINS deferred to Dr. Holm to answer the question.
DR. HOLM responded that there have been no repercussions at this
time because the FDA has not yet put forth a licensing
procedure. He offered his belief that three or four other
states have not yet licensed and are therefore in the same
situation as Alaska and do not monitor the drugs coming into the
state. However, he continued, years down the road when the FDA
gets around to it, the FDA would be in charge and have all the
rules and regulations fall under whatever the FDA requires and
not necessarily what Alaska thinks is important.
REPRESENTATIVE WOOL remarked that it looks like a couple of the
situations mentioned are different - for example, the compounder
in Massachusetts was bad practice or fraud, rather than
counterfeit. He surmised that that was not a supply chain
problem as illustrated on [slide 5]. He inquired whether Dr.
Holm agrees that the compounding problem was a different thing.
DR. HOLM concurred that the compounding problem is a different
thing and advised that that is a reason for licensing. While
wholesaler drug distributors have been referenced, it also
includes outsourcing facilities, which that facility would have
fallen under. It goes back to inspections, he said, and that
facility would have been required to have some form of
inspection that [the Board of Pharmacy] would have had to accept
before allowing the facility to operate in Alaska. Without an
inspection, [the board] would not have allowed the facility to
ship anything into Alaska. Based on what has been on the news,
that facility would not have passed, period.
3:59:26 PM
REPRESENTATIVE SADDLER, regarding what would happen if the state
doesn't pass the bill, added that unless and until the federal
government required that licensing federally, there would be no
stick that the State of Alaska could use to punish someone. For
example, if the compounding facility in Massachusetts shipped to
Alaska and it did not produce good product, Alaska would have no
statute with which to prosecute the facility because there would
be no law requiring them to be inspected to get a license.
4:00:20 PM
SCOTT WATTS, Pharmacist, testified in support of HB 9. He said
he is the owner of several pharmacies in Juneau and explained
that a pharmacist's main responsibility is ensuring that the
right person gets the right medication in the right dose.
Pharmacists can do all of that in their pharmacies, he noted,
but they do need to make sure that that pill is the right pill
that is being ordered. He advised that pharmacists are getting
a lot of constraints from pharmacy benefit managers (PBMs),
middlemen that the committee may be hearing about.
MR. WATTS, regarding maximum allowable cost (MAC) prices,
related that at times pharmacists have difficulty finding a
medication from the larger wholesalers at that [MAC] price.
This forces pharmacies to go out to the smaller wholesalers, he
said. For example, he gets phone calls daily from small
wholesalers saying they have this medication at this price
much lower than what his wholesalers are offering it for. He
pointed out that pharmacists don't know if this small wholesaler
is calling from a garage without having verification that
they've been licensed or at least that the state has the ability
to license that.
MR. WATTS noted that a pharmacist sending out prescriptions to
other states must be licensed in the state that the prescription
is being sent to, and the pharmacy must also be licensed. The
other states want to verify that a pharmacist isn't doing things
under the table or incorrectly. He reiterated his strong
support for HB 9.
4:02:25 PM
REPRESENTATIVE BIRCH shared that long ago he studied some
analysis techniques for minerals to get a detailed analysis. He
asked how a pharmacist confirms that a pharmaceutical is what it
is purported to be.
MR. WATTS replied that there are no ways in-house to test a
medication. Pharmacists are relying on the manufacturers and
whether the drug can be tracked from the manufacturer to the
wholesalers. The FDA inspects the manufacturers, he said, and
that's where the assurance is that that is the appropriate drug.
Also, there are markings for identifying a drug. When that
supply chain is not clear it is hard, he added, and that is
where pharmacists need the assurance that that pill and that
bottle is what it is purported to be.
REPRESENTATIVE BIRCH noted there are often five pages of tiny
print stating what a drug might do, while street drugs are often
something that an amateur chemist has tweaked. He asked whether
a pharmacist can get a rock-solid signature for a drug, so it is
known what it is.
MR. WATTS responded that at the pharmacy level, the pharmacist
is looking at appearance and markings of the tablet.
4:05:24 PM
CHAIR KITO held over HB 9.
4:05:35 PM
ADJOURNMENT
There being no further business before the committee, the House
Labor and Commerce Standing Committee meeting was adjourned at
4:06 p.m.
| Document Name | Date/Time | Subjects |
|---|---|---|
| HB009 Fiscal Note DCCED-CBPL 3.31.17.pdf |
HL&C 4/7/2017 3:15:00 PM |
HB 9 |
| HB009 Summary of Changes version A to version J 4.6.17.pdf |
HL&C 4/7/2017 3:15:00 PM |
HB 9 |
| HB009 Supporting Documents-Letter of Support Alaska Board of Pharmacy 3.6.17.pdf |
HL&C 4/7/2017 3:15:00 PM |
HB 9 |
| HB009 Supporting Documents-Presentation Board of Pharmacy 4.7.17.pdf |
HL&C 4/7/2017 3:15:00 PM |
HB 9 |
| HB009 version J 4.6.17.pdf |
HL&C 4/7/2017 3:15:00 PM |
HB 9 |
| HB124 Explanation of changes version A to version D 4.6.17.pdf |
HL&C 4/7/2017 3:15:00 PM |
HB 124 |
| HB124 Sectional Analysis ver D 4.6.17.pdf |
HL&C 4/7/2017 3:15:00 PM |
HB 124 |
| HB124 Supporting Documents-Letters of Support 4.1.17.pdf |
HL&C 4/7/2017 3:15:00 PM |
HB 124 |
| HB124 ver D 4.6.17.pdf |
HL&C 4/7/2017 3:15:00 PM |
HB 124 |
| HB009 Sectional Analysis version J 4.7.17.pdf |
HL&C 4/7/2017 3:15:00 PM |
HB 9 |