Approved: February 8, 2006
The meeting was called to order by Chairman Jim Morrison at 1:30 p.m. on February 7, 2006, in Room 526-S of the Capitol.
All members were present except Representatives Mast and Kelley, both 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:
Dan Bellingham, Healthcare Distribution Management Association
Nancy Zogleman, Director, Government Relations, Pfizer
Others attending:
See attached list (not available on electronic copy).
Staff
Mary Galligan briefed the committee on the similarities and differences between
HB 2397 and
HB 2820. (Attachment
1) She noted variations in the definitions—the definition of wholesaler
includes manufacturers in the former, but is excluded in the latter. She stated
that section three identifies the main focus of the bills; both require that a
wholesale distributor be licensed, not merely registered. She identified
several differences in the bills: HB 2820 requires information
only on the designated representative, whereas HB 2397 requires
information on the representative and on other staff members; HB 2820
requires the Board of Pharmacy to physically inspect premises of the wholesaler,
but not so HB 2397; the bond differs in each bill; HB 2397
requires a licensee to pass a test, but HB 2820 does not. She
commented on several discrepancies: the need to specify the length of time a
license is valid, a clarification if background checks are required before a
wholesaler is licensed, the conditions required for a wholesaler to receive
drugs from a pharmacy, a delineation of how the distribution of a drug is to be
halted, and what information can be disclosed. She concluded by noting that
HB 2820 does not address what percent of inventory must be sold to
pharmacies; HB 2397 requires 95% of inventory to be sold to
pharmacies, adding that criminal penalty levels also differ between the two
bills.
The Chair opened the hearing on
HB 2397.
Dan Bellingham, Healthcare Distribution Management Association, spoke as a
proponent. (Attachment
2) He gave background on his association and commented on issues of concern
regarding HB 2397, recommending changes regarding the definition
“normal distribution channel” and the licensing requirements of the designated
representative, suggesting that the latter delete the examination requirement.
He stated that he opposes the requirement of 95% of sales to a pharmacy and the
penalties mandated by the bill.
Answering a question, he said both bills (HB 2397 and HB
2820) create distribution problems for wholesalers.
Nancy Zogleman, Director, Government Relations, Pfizer, spoke as an opponent to
the bill. (Attachment
3) She explained that a counterfeit Lipitor drug sold in the Kansas City
market three years ago illustrates the problem of a faulty distribution system,
which the bill addresses. She commented that although the top three wholesalers
account for 90% of the drug distribution in the United State, there are
thousands of registered wholesalers, a fact which creates a large secondary
market. Through unscrupulous wholesalers, counterfeit drugs enter the market,
not only creating a danger to the public from unregulated drugs, but also, if a
drug must be withdrawn from the market, absence of that drug can endanger many
consumers whose health may depend on that drug. She recommended strict
licensing requirements for wholesalers, a pedigree or paper trail for each drug,
and increased penalties for violators. She said that legislation was rapidly
evolving, and she recommended HB 2820 as a better bill that
HB 2397.
Answering questions, Ms. Zogleman said after Pfizer turns a drug over to a
wholesaler, the companies loses control of the product, commenting that the
rationale of either bill is protection of the public. She replied that federal
legislation usually is created after a number of states have addressed an issue.
Representative Hill commented that the bill appears to be a wise move toward
protecting the public, but he expressed concern about the fiscal cost and
wondered about unintended consequences. Ms. Zogleman replied that presently
wholesalers are paying a $300 fee, but that statutorily the ceiling is $500.
She said many states are enacting or considering similar license requirements
for drug wholesalers.
The Chair closed the hearing and announced that the committee would work the
bill(s) after turnaround.
A fiscal note was included. (Attachment
4)
Staff Melissa Calderwood briefed the committee on
HB 2452. She said that the bill creates a new law and amends
current law to create a central registry for all licensed nurses and mental
health technicians who have resigned or been terminated from employment, the
registry being made available to health-care providers who employ licensed
nurses or licensed mental health technicians. All health-care providers are
required to submit names of such persons, including details relating to the
resignation or termination, to a Board Administrator. The nurse or technician
is allowed to submit a written response in the report. The board and its
officers are immune from civil liability for information in the report; however,
employees are not allowed to disclose any further information gained from the
registry. A fiscal note was included.
(Attachment 5)
Staff Mary Galligan reviewed
HB 2497, commenting that the bill amended existing law, imposing
certain restrictions as to who can work at or live or volunteer at certain
child-care facilities. The bill allows the secretary of the Kansas Department
of Health and Environment to have access to background information regarding
those employees, volunteers, or residents. Placement agency staff who are
responsible for this information are required under criminal penalties to keep
the information confidential. A fiscal note was included in the briefing.
(Attachment 6)
The minutes for the February 6, 2006, meeting were approved.
The meeting was adjourned at 2:38 p.m. The next meeting is scheduled for Wednesday, February 8, 2006.