Approved: March 2, 2006
The meeting was called to order by Vice-Chair Peggy Mast at 1:30 P.M. on March 1, 2006, in Room 526-S of the Capitol.
All members were present except Representatives Watkins, Kelley, Kilpatrick, Morrison, Landwehr, and Kirk, all of whom were excused.
Committee staff present:
Melissa Calderwood, Kansas
Legislative Research Department
Mary Galligan, Kansas Legislative Research Department
Renae Jefferies, Revisor of Statutes=
Office
Gary Deeter, Committee Secretary
Conferees appearing before the committee:
David Searle, Director, Pharmacy
Development, Pfizer
Carmen Catizone, Executive Director, National Association of Boards of
PharmacyDebra Billingsley, Executive Secretary, Kansas State Board of Pharmacy
Kevin Nicholson, Vice President of Pharmacy Regulatory Affairs, National
Association of Chain Drug Stores
David Gonzales, Director, State Government Affairs, Healthcare Distribution
Management Association
Others attending:
See attached list (not available on electronic copy).
The Chair opened the hearing on
HB 2820 and noted a previous hearing on a similar bill,
HB 2397, which
hearing was on 2-7.
David Searle, Director, Pharmacy Development, Pfizer, testified as a proponent
for the proposed legislation. (Attachment
1) He related the dangers of counterfeit drugs, noting the need to
regulate the secondary market by defining normal distribution and creating a
pedigree or footprint to trace each drug through the distribution system. He
listed the advantages of the bill, saying that it safeguards the state’s drug
supply through the Kansas Board of Pharmacy, whose licensing and background
checks will better protect Kansas citizens.
Carmen Catizone, Executive Director, National Association of Boards of Pharmacy,
testified in favor of the bill, noting that the NABP is an independent,
impartial association that assists state boards to develop and implement uniform
standards.
(Attachment 2) and (Attachment
3) Noting that about 15 states have similar legislation, he cited evidence
to show that the present tracking is inadequate, but that the present bill has
safeguards to prevent Kansas from becoming a haven for unscrupulous wholesalers.
Patrick Hubbell, representing PhRMA, offered written testimony in support of the
bill. (Attachment
4)
Debra Billingsley, Executive Secretary, Kansas State Board of Pharmacy, speaking
as a neutral party, delineated various concerns expressed by the Board. (Attachment
5) She estimated each pharmacy would expend $10,000 to implement
electronic tracking; she said some definitions are confusing or conflict with
present statutes or regulations; she commented that the cost of background
checks and inspections could be onerous if not passed on to distributors; and
she said the mandates are unrealistic. She noted that the Board is in agreement
with the theory of the bill, but is reluctant to implement it at the present
time.
Kevin Nicholson, Vice President of Pharmacy Regulatory Affairs, National
Association of Chain Drug Stores, spoke as opponent to the bill
(Attachment 6) and suggested amendments that he said would make the bill
more acceptable.
(Attachment 7) He noted that the present bill contains various inaccuracies
and that because of continued changes at the federal level and in a number of
states, counterfeit drug cases in 2005 fell to nearly half the number in 2004.
He explained that by 2010 an effective tracking system will become common—the
RFID, or radio-frequency identification, an electronic chip that will provide a
complete pedigree for each prescription bottle. He asked the committee to delay
action on what he called a premature bill.
David Gonzales, Director, State Government Affairs, Healthcare Distribution
Management Association, testified in opposition to the bill. He said his
colleague, Dan Bellingham, gave testimony opposing a similar bill (HB 2397)
on
February 7, testimony which he said applied to this bill as well. He cited
two problems with the bill: First, the licensing requirements are onerous, and,
second, the pedigree requirements unnecessarily restrict a wholesaler’s ability
to serve its customers. Noting that the ideal pedigree will be RFID, he said
90% of drugs are easily tracked because they follow the normal distribution
chain. However, 10% of drugs are purchased outside that chain when a wholesaler
does not buy directly from a manufacturer; the bill makes tracking that 10%
becomes unnecessarily restrictive.
A fiscal note was provided for committee members.
(Attachment 7)
Members posed questions to conferees. Ms. Billingsley said the Federal Drug
Administration (FDA) began but never completed a pedigree system. Mr. Catizone
explained that the FDA does not have resources to oversee drug tracking, since
licensing rests with the states, observing that if 1% of drugs were
counterfeited, that would total 35 million prescriptions, a Herculean task to
regulate. Ms. Billingsley said that the Board of Pharmacy regulates wholesalers
intrastate and requests inspections from resident states for out-of-state
wholesalers. Mr. Catizone said the patchwork of regulations is disappearing as
more states impose stricter tracking statutes. Mr. Gonzales stated that his
association has offered a federal model for licensing to the FDA. Mr. Catizone
added that the tracking process can be implemented, but not yet at the unit
level. A member commented that at present Kansas regulates puppy mills more
stringently than it does prescription drugs. Mr. Catizone said Indiana has
implemented an effective drug-tracking system paid for by manufacturer and
wholesaler fees. A member expressed concern that wholesalers would simply pass
on these fees to retailers.
The Chair closed the hearing.
The minutes for February 21, 2006, were approved.
Staff Mary Galligan briefed the committee on
HB
2813.
She said the bill repeals one section of the nurse practice act which
allows a nurse to practice up to 120 days pending receipt of the results of
his/her licensing examination.
Staff Melissa Calderwood explained two similar bills,
HB 2852 and
HB 2853, both of which create new law requiring the State Board of
Nursing to require fingerprinting and criminal history record checks before
licensing nurses, practical nurses, and mental health technicians. She noted
that in both bills there is no language directing the deposit of funds into the
state treasury nor does the bill specify how the funds would be generated. The
bill assumes but does not state that the Board will increase license fees for
applicants.
The meeting was adjourned at 2:54 p.m. The next meeting is scheduled for
Thursday, March 2, 2006.