Legislature(2015 - 2016)SENATE FINANCE 532
04/11/2016 09:00 AM Senate FINANCE
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| Audio | Topic |
|---|---|
| Start | |
| SB101 | |
| SB201 | |
| SJR12 | |
| SB196 | |
| SB210 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| += | SB 101 | TELECONFERENCED | |
| += | SB 200 | TELECONFERENCED | |
| += | SB 201 | TELECONFERENCED | |
| += | SJR 12 | TELECONFERENCED | |
| += | SB 196 | TELECONFERENCED | |
| += | SB 210 | TELECONFERENCED | |
| + | TELECONFERENCED |
SENATE BILL NO. 201
"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."
9:29:03 AM
Co-Chair MacKinnon referred to a document from Senator
Cathy Giessel dated April 9, 2016, in response to questions
from the committee (copy on file).
JANE CONWAY, STAFF, SENATOR CATHY GIESSEL, addressed the
document that answered the questions that had come up at
the previous hearing of the bill:
1. Would SB 201 apply to regulation of international
wholesalers? (sub question.....do our AK licensees do
business with wholesalers in Mexico or Canada or
similar?) But even so, we can't regulate a business in
another country could we?
Alaskan pharmacies do not do business with wholesalers
in Mexico or Canada since they presumably don't sell
US FDA approved drugs and as such the FDA does not
allow import of said drugs.
Ms. Conway specified that drugs must be licensed in the
United States and be approved by the United States Federal
Drug Administration (FDA).
Co-Chair MacKinnon restated that her question had been if
an international or foreign country could market directly
to Alaskans, and somehow bypass the FDA.
Co-Chair MacKinnon referred to the first question, and
asked for professional feedback on the matter.
DIRK WHITE, PHARMACIST, SITKA (via teleconference), relayed
that he recently finished his term as president of the
Board of Pharmacy. He stated there had been ongoing
conversation regarding importation of drugs from foreign
countries. He recounted that in the Clinton era, the
importation of pharmaceuticals was going to be allowed but
was later quashed by the U.S. Justice Department. He
discussed the Drug Quality Security Act (DQSA), and
informed that there was a practice called "track and
trace," under which pharmacists were ensured as to the
provenance and pedigree of the items that had been ordered.
He noted that he received an electronic file every time he
placed an order from a wholesaler, which would show the
pedigree of each item that was ordered. He discussed
prevention efforts by the Board of Pharmacy to ensure that
wholesalers were following DQSA regulations. He pointed out
that the board had no jurisdiction over international
pharmacies or wholesalers, and added that there were
loopholes.
9:34:01 AM
Co-Chair MacKinnon was unclear as to Mr. White's response
on the matter of directly accepting drugs from wholesalers.
She wondered if the bill should endeavor to prevent the
ability to purchase drugs from a wholesaler that marketed
internationally. She wondered if the committee should amend
the bill to ban the ability to purchase internationally.
Mr. White clarified that the prohibition she described was
essentially what pharmacists had been operating under.
According to regulations, he should not be able to purchase
from an international pharmacy or wholesaler, but he was
sure there was a way around the rule, which is why he had
mentioned a loophole. He referred to copious amounts of
packages that were being sent from out of state, and
thought the FDA was unable to inspect them all. He asserted
that he would always order from a major national
wholesaler. There were also small regional businesses which
were licensed and certified and inspected, and were able to
ship into other states. He did not see that the
international concern was a priority.
Ms. Conway spoke to the regulation of internet sales on the
first page of the document:
2. Are internet sales regulated? Sub question - would
AK licensees purchase off the internet? Are they even
allowed to do that?
Alaskan Pharmacies may purchase off the internet from
Wholesalers licensed in the United States and purchase
FDA approved drugs. Alaskan pharmacies may not
purchase and then dispense drugs from wholesalers
(presumably out of the country) that are NOT FDA
approved.
Ms. Conway stated that individuals could purchase
medications over the internet. She noted that there had
been discussion about an internet corporation forming to
address the dot-com pharmacy industry; so that a person
could look up an internet pharmacy to see if it was
certified as handling FDA-approved drugs.
Co-Chair MacKinnon related that the committee had addressed
the fiscal note on April 9, 2016. She noted that public
testimony had opened and closed on the same date.
Vice-Chair Micciche MOVED to report SB 201 out of Committee
with individual recommendations and the accompanying fiscal
note.
SB 201 was REPORTED out of committee with "no
recommendation" and with one previously published fiscal
note: FN1 (CED).
9:38:36 AM
AT EASE
9:42:06 AM
RECONVENED
| Document Name | Date/Time | Subjects |
|---|---|---|
| SB 200 Public Testimony Nees.pdf |
SFIN 4/11/2016 9:00:00 AM |
SB 200 |
| SB 200 NEA Alaska Letter.pdf |
SFIN 4/11/2016 9:00:00 AM |
SB 200 |
| SB 210 Community Revenue Sharing Estimates.pdf |
SFIN 4/11/2016 9:00:00 AM |
SB 210 |
| SB 201 Responses to questions during SB 201 hearing SFIN 4.pdf |
SFIN 4/11/2016 9:00:00 AM |
SB 201 |
| SB 210 with $38.2 million vs Status Quo with $60 million.pdf |
SFIN 4/11/2016 9:00:00 AM |
SB 210 |