Veterinary Medicine Advisory Committee, Animal Drug Manufactur

266 Pages·1998·0.39 MB·English

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ATDEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR VETERINARY MEDICINE
VETERINARY MEDICINE ADVISORY COMMITTEE
ANIMAL DRUG MANUFACTURING
Wednesday, November 12, 1997
8:30 a.m.
Holiday Inn
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2 Montgomery Avenue
Goshen Hall
Gaithersburg, Maryland
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PARTICIPANTS
Donald Lein, DVM, Ph.D., Chairperson
Robert Guidos, Executive Secretary
MEMBERS AND CONSULTANTS
Steven Barker, Ph.D.
George Cooper, Ph.D.
Ling-Jung (Kelvin) Koong, Ph.D.
Oscar Fletcher, DVM, Ph.D.
Alice Wolf, DVM
Ruth Francis-Floyd, DVM
Douglas Kemp, Pharm. D.
Diane Gerken, DVM, Ph.D.
Sue Hudson-Duran, R.Ph, MS
Gary Koritz, DVM, Ph.D.
Keith Sterner, DVM
Janis Cleland, DVM
Rolland Poust, Ph.D.
William Ravis, Ph.D.
CVM
Stephen F. Sundlof, DVM, Ph.D.
Andy Beaulieu, DVM
Gloria Dunnavan
Charles Eirkson
Manuel Garza, Kansas City District Office
Patricia Leinbach, Ph.D.
Robert Livingston, Ph.D.
William Marnane
David Newkirk, Ph.D.
INDUSTRY
Joseph Gloyd, DVM, (AVMA)
Jess Stribling, Esq. (ADA)
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C O N T E N T S
PAGE NO.
Opening Remarks: 4
Mr. Robert Guidos
Introductory Remarks:
Dr. Stephen Sundlof 7
Seminar Presentation-Drug Manufacturing:
Dr. Rolland Poust 11
Animal Drug Manufacturing Issues Overview:
Dr. Stephen Sundlof 86
Presentation of Certificates to Outgoing Members:
Dr. Stephen Sundlof 124
DISCUSSION OF QUESTION 1
CVM Presentation:
Dr. David Newkirk 126
DISCUSSION OF QUESTION 2
CVM Presentation:
Mr. Charles Eirkson 150
DISCUSSION OF QUESTION 3
CVM Presentation:
Dr. Andrew Beaulieu 207
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P R O C E E D I N G S
Opening Remarks
MR. GUIDOS: Welcome to the Center for Veterinary
Medicine's Advisory Committee Meeting for November 12, 1997.
Today, we are going to discuss issues relating to the
manufacture of animal drugs.
First of all, I would like to introduce myself.
My name is Robert Guidos. I am Dr. Sundlof's special
assistant at the Center for Veterinary Medicine. I am here
today to fill in for Dick Geyer who is the Executive
Secretary for this committee. He, unfortunately, is not
able to be here because he had a death in his family this
past week.
I am told that Dr. Lein is such an expert at
running these meetings, I won't have to do anything. So I
am going to hold him to that.
First of all, I would like to thank the members
here today and the consultants for the work that they have
done in preparing for this meeting. I would like to thank
Dick Geyer and Jackie Pace for the incredible amount of work
they have done preparing for this meeting, as well, and the
other employees of the Center for Veterinary Medicine, as
well as industry representatives and the representatives
from the veterinary profession.
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Before we get started, I am going to need to read
the Conflict of Interest statement for the meeting of the
Veterinary Medicine Advisory Committee for November 12 and
13th of 1997.
The following announcement addresses the issues of
conflict of interest with regard to this meeting and is made
a part of the record to preclude even the appearance of such
at this meeting.
The Federal conflict of interest laws preclude the
participation of committee members and consultants in
advisory committee meetings if they have a conflict of
interest unless a waiver from exclusion is granted by the
agency.
Based on the submitted agenda for this meeting,
and a review of all financial interests reported by the
committee participants, it has been determined that all
interest in the firms regulated by the Center for Veterinary
Medicine which have been reported by the participants
present no potential for a conflict of interest at this
meeting with the following exceptions:
In accordance with 18 U.S.C. 208(b)(3), a waiver
has been granted to Dr. Steven A. Barker, Dr. Diane K.
Gerken, Dr. Keith E. Sterner, Dr. Alice Wolf, Dr. Janis L.
Cleland, and Dr. William A. Ravis.
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Under the terms of the waiver, Drs. Barker,
Gerken, Sterner, Wolf, Cleland, and Ravis will be permitted
to participate fully in the discussions and deliberations
relating to the quality standards for manufacture of animal
drugs, such as Current Good Manufacturing Practices, CGMPs.
A copy of this waiver statement may be obtained
through the agency's Freedom of Information Office at
HFI-35, Room 2A-15 of the Parklawn Building.
The statement was prepared by Dick Geyer on
November 4, 1997, and Dr. Sundlof concurred on 11-7-97.
Now, for a few housekeeping items. I am going to
pass around a phone list to members just to make sure the
list accurately reflects their current addresses, and that
will be coming around.
Also, for the members and other participants who
received a notebook prior to this meeting, there are some
extra inserts that may have been produced since your book
was prepared. They are on the back corner on the left on
the table.
Jackie Pace also standing in the back of the room
will be able to provide any other attendees here today with
other materials if they are interested in receiving them.
Just ask Jackie and she will put your name on a list and
then she will send you those materials next week.
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I have some envelopes I need to pass around also
to the members for them to -- basically, it's return receipt
envelopes for your travel vouchers. I don't know if there
are members who have received them. They are addressed to
Susan Simmons. If your travel voucher package already
includes that, please don't take that.
Also, Jess Stribling from the Animal Drug Alliance
has asked me to pass around a letter that was sent to him by
Dr. Sundlof on October 3rd, just for you to include in your
package. I don't think it was included in your material.
With that, I just want to make an announcement
about lunch. Lunch will be served between 12:00 and 1:00.
It is going to be promptly over at 1:00. I am going to try
and keep the members and the participants to a strict
schedule here. Lunch will be next-door behind the salad
bar. For those of you who have already participated, you
know where that is. If you have any questions about that,
just let me know.
If you have any other comments or questions,
please, either Jackie Pace is in the back of the room or
myself can help you.
With that, I would like to introduce Dr. Stephen
Sundlof, who is the Director of the Center for Veterinary
Medicine, and he has some introductory remarks that he would
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like to make.
Introductory Remarks
DR. SUNDLOF: Thank you very much, Bob.
I would like to welcome all of the members of the
Veterinary Medicine Advisory Committee in addition to the
consultants that we have asked to attend this because of
their expertise in the area of manufacturing chemistry.
I would like to pass along Dick Geyer's regrets
that he could not attend this today. As Bob indicated, Dick
has been intimately involved in this issue, putting together
this program, and he sincerely regrets that he could not be
in attendance today, but we are in good hands with Bob
Guidos and with our chairman, Dr. Lein. I am sure we will
be able to carry on admirably in the absence of Dick Geyer.
I would also like to mention that tomorrow, most
of the senior staff at FDA and CVM will not be attending
this meeting and we very much regret that. We are scheduled
to have our management meeting in Charlottesville, Virginia,
and the only dates that we could get in a whole year was the
date tomorrow and the next day.
So, the fact that I won't be here tomorrow and a
number of the other senior managers in CVM won't be here
tomorrow is not an indication of the importance that we
place on this meeting. It was an unfortunate conflict of
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interest that we felt we just couldn't reschedule.
So, again I apologize for that. I will be here
all day to try and answer any questions, so if there is
things that anybody needs to talk to me personally about or
other senior managers in the Center, grab us today and we
will be glad to try and answer any questions you have.
We have a really outstanding meeting I think
scheduled for today. This is a very complex issue,
manufacturing chemistry, and there are not a lot of people
that know a whole lot about that, and most of the experts
here on the VMAC panel are not experts in this area.
I think it is a tribute to the pharmaceutical
industry that we just more or less take the quality of these
products for granted, and we don't need to know as much --
for most of the people here -- don't need to know all the
intricate details that are associated with manufacturing
chemistry, but it is a very, very important process and
again one that, as you found out through reading, very
complex.
So, in order to help us all learn a little bit
more, myself included, we had discussed at the last meeting
whether or not it would be possible to have a tour, an
actual GMP inspection-type tour through a veterinary drug
manufacturer.
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