1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE
WITH THE PEDIATRIC SUBCOMMITTEE
OF THE ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE
Holiday
Inn
2
PARTICIPANTS
Matthew
Rudorfer, M.D., Chair
Anuja M. Patel,
M.P.H., Executive Secretary
PSYCHOPHARMACOLOGICAL DRUGS ADVISORY COMMITTEE
MEMBERS
Tana Grady-Weliky, M.D.
Irene
E. Ortiz, M.D.
Richard P. Malone,
M.D
Wayne K. Goodman, M.D.
James J. McGough, M.D.
Jean
E. Bronstein, R.N., M.S.
(Consumer
Rep)
Andrew C. Leon, Ph.D.
Philip S. Wang, M.D. M.P.H., Dr. P.H.
Dilip J. Mehta, M.D., Ph.D.,
(Industry Rep)
ANTI-INFECTIVE
DRUGS ADVISORY COMMITTEE
MEMBERS
Steven C. Ebert, Pharm. D. (Consumer Rep)
Mary P. Glode, M.D.
Samuel
D. Maldonado, M.D., M.P.H.
(Industry
Rep)
PEDIATRIC
SUBCOMMITTEE OF THE ANTI-INFECTIVE DRUGS
ADVISORY
COMMITTEE MEMBERS
P. Joan Chesney, M.D.
Mary
Glode, M.D.
Steven Ebert, Pharm. D. (Consumer Rep)
Robert Nelson, M.D., Ph.D.
Richard Gorman, M.D., FAAP
Robert J. Fink, M.D.
Susan Fuchs, M.D.
David Danford, M.D.
Victor Santana, M.D.
Mark Hudak, M.D.
Judith R. O'Fallon, Ph.D.
SGE CONSULTANTS
(VOTING)
Elizabeth B. Andrews, Ph.D.
Norman Fost, M.D., M.P.H.
Charles
E. Irwin, Jr., M.D.
Lauren K. Leslie, M.D., FAAP
James
M. Perrin, M.D.
Cynthia R. Pfeffer,
M.D.
SGE PATIENT
REPRESENTATIVE (VOTING)
Gail W. Griffith
3
PARTICIPANTS (Continued)
GOVERNMENT
EMPLOYEE (non-voting)
Daniel
S. Pine, M.D.
FDA
Robert Temple, M.D.
Russell
G. Katz, M.D.
Thomas Laughren, M.D.
M. Dianne Murphy, M.D.
Susan Cummins, M.D., MPH
Anne Trontell, M.D., MPH
4
C
O N T E N T S
PAGE
Call to Order
and Opening Remarks:
Matthew Rudorfer, M.D.
6
Introductions
8
Conflict of
Interest Statement:
Anuja M. Patel, MPH
15
Overview of
Issues:
Russell Katz, M.D.
19
Pediatric Drug
Development Program:
Dianne Murphy, M.D.
26
Pediatric
Depression and Its Treatment:
Cynthia R. Pfeffer, M.D.
39
Suicide and
Related Problems in Adolescents:
David Shaffer, FRCP (Lond) FRC Psych
60
Open Public
Hearing
Irving Kirsch and David Antonuccio
79
Lisa
Van Syckel
82
Ann Blake Tracy, Ph.D.
83
Tom Woodward
85
Mark Miller
87
Corey and Jay Baadsgaard
90
Joyce Storey 91
Jame Tierney
93
Donna and Mark Taylor
95
Shannon
Baker
97
Dawn Rider
98
Sara Bostock
100
Vera Hassner Sharav
103
Cynthia Brockman
104
Todd and Eileen
Shivak
107
Andy Vickery
109
Rosie Carr Meysenburg
111
Rachel Adler
112
Pepper Draper
115
Donald Marks, M.D., Ph.D.
117
Leah Harris
119
Donald Farber
121
Matthew Piepenberg
125
Terri Williams
127
Glenn McIntosh
129
Delnora Duprey
132
Joe Pittman
133
Richard Mack
135
Noah Wright Smith
137
Marion
Goff
139
5
C O N T E N T S (Continued)
PAGE
Open Public
Hearing (Continued)
Gary Cheslek, M.D.
142
Sherri Walton
144
Peter
R. Breggin, M.D.
146
Robert Fritz
148
Suzanne Vogel-Scibilia, M.D.
152
Dennis
Winter
155
Steve Cole
157
Allan Routhier
158
Daniel J. Safer, M.D.
161
Julie Magno Zito, M.D.
163
Joseph Glenmullen, M.D.
164
Linda Cheslek
165
Jeff Avery
167
Harry Skigis
169
Pamela Wild
170
Karen Barth Menzies
172
Amy Coburn
174
Sharon McBride
175
Thomas Moore, M.D.
178
Pediatric and
Adolescent Antidepressant Drug Use
in the
Gianna C. Rigoni, Pharm.D., M.S.
181
One-Year
Post-Exclusivity-Mandated Adverse Event
Review for
Paroxetine and Citalopram:
Solomon Iyasu, M.D., MPH
195
Office of Drug
Safety Data Resources
for the Study of
Suicidal Events:
Andrew D. Mosholder, M.D., MPH
215
Open Public
Hearing
David Fassler, M.D.
225
Regulatory
History on Antidepressants and
Suicidality and
Update on Current Plans for
Analysis of
Pediatric Suicidality Data:
Thomas Laughren, M.D.
230
Suicidality
Classification Project:
Kelly Posner,
Ph.D.
265
Plans for
Analysis of Patient Level Data
for Pediatric
Studies:
Tarek Hammad, M.D., Ph.D., M.Sc., M.S.
273
Open Committee
Discussion
291
6
1
Call to Order and Opening Remarks
2
DR. RUDORFER: I am Dr.
Matthew Rudorfer,
3 a research psychiatrist at the
National Institute
4
of Mental Health, today
wearing my hat as Chair of
5 the Advisory
Committee.
6
As you settle in, please take this
7 opportunity to put into silent
mode your cell
8 phones and any other devices that
ring, beep, or
9 play show
tunes.
10
I have some official language to read.
11 All committee members and
consultants have been
12 provided with copies of background
materials from
13 the FDA and with copies of letters
from the public
14 that were received by the January
26th deadline.
15 The background materials have been
posted on the
16 FDA web site. Copies of all these materials
are
17 available for viewing at the FDA
desk outside this
18 room.
19
We have a large table and a full house as
20 you can see and a very important
and exciting topic
21 to discuss, so we would like to
start with a few
22 rules of order. FDA relies on its
advisory
23 committees to provide the best
possible scientific
24 advice available to assist us in a
discussion of
25 complex topics. We understand that issues raised
7
1 during the meeting may well lead
to conversations
2 over breaks or during
lunch.
3
However, one of the benefits of an
4 advisory committee meeting is that
discussions take
5 place in an open and public
forum. To that end,
we
6 request that members of the
committees not engage
7 in off-record conversations on
today's topic during
8 the breaks and
lunch.
9
Whenever there is an important topic to be
10 discussed, there are a variety of
opinions. One
of
11 our goals today is for this
meeting to be conducted
12 in a fair and open way where every
participant is
13 listened to carefully and treated
with dignity,
14 courtesy, and respect. Anyone
whose behavior is
15 disruptive to the meeting will be
asked to leave.
16
We are confident that everyone here is
17 sensitive to these issues and can
appreciate that
18 these comments are intended as a
gentle reminder.
19 We look forward to a productive
and interesting
20 meeting.
21
Just to reiterate a couple of points.
22 This is an unusual meeting in that
we have two
23 advisory committees represented
here,
24 Psychopharmacologic Drugs and a
subcommittee that
25 is equivalent of a Pediatric Drugs
Advisory
8
1 Committee chaired by Dr. Joan
Chesney here to my
2 left.
3
Suppose we begin by going around the table
4 for introductions. Can we start at that
end,
5 please.
6
Introductions
7
DR. TEMPLE: I am Bob
Temple. I am
the
8 Office Director for Office of Drug
Evaluation I.
9
DR. KATZ: Russ Katz,
Division Director of
10 the Division of
Neuropharmacological Drug Products,
11 FDA.
12 DR.
LAUGHREN: Tom Laughren,
Psychopharm
13 Team Leader in the Neuropharm
Division.
14
DR. MURPHY: Dianne Murphy,
Office
15 Director, Office of
Counterterrorism and Pediatric
16 Drug
Development.
17
DR. CUMMINS: Susan Cummins,
Medical Team
18 Leader with the Division of
Pediatric Drug
19 Development.
20
DR. TRONTELL: Anne Trontell,
Deputy
21 Director, Office of Drug
Safety.
22
DR. FUCHS: Susan Fuchs,
member of the
23 Pediatric Subcommittee of the
Anti-Infective Drugs
24 Advisory
Committee.
25
DR. FINK: Bob Fink,
pediatric
9
1 pulmonologist, Dayton,
Ohio.
2
DR. ORTIZ: Irene Ortiz,
geriatric
3 psychiatrist, Albuquerque VA and
the University of
4 New Mexico.
5
DR. LESLIE: Lauren Leslie, behavioral
6 and developmental pediatrician and
health services
7 researcher in San
Diego.
8
DR. LEON: Andrew Leon,
Professor of
9 Biostatistics and Psychiatry at
Cornell Medical
10 College.
11
DR. GOODMAN: Wayne Goodman,
Professor and
12 Chairman, Department of Psychiatry
at the
13 University of
Florida.
14
DR. PFEFFER: Cynthia
Pfeffer, Adolescent
15 Psychiatrist and Professor of
Psychiatry at Weill
16 Medical College of Cornell
University.
17
DR. GORMAN: Rich Gorman,
pediatrician in
18 private practice in Ellicott City
and member of the
19 Pediatric Advisory
Subcommittee.
20
DR. GLODE: Mary Glode,
Professor of
21 Pediatrics, Pediatric Infectious
Disease Specialist
22 at Children's Hospital, University
of Colorado at
23 Denver.
24
DR. HUDAK: Mark Hudak,
neonatologist and
25 Professor of Pediatrics,
University of Florida at
10
1 Jacksonville, and member of the
Pediatric
2
Subcommittee.
3
DR. MALONE: Richard Malone,
child
4 psychiatrist, Drexel University,
College of
5 Medicine, and I am a member of the
Psychopharm
6 Advisory
Committee.
7
DR. SANTANA: Victor Santana,
pediatric
8 hematologist/oncologist, St.
Jude's Children's
9 Research Hospital and University
of Tennessee at
10 Memphis,
Tennessee.
11
MS. PATEL: Anuja Patel,
Executive
12 Secretary, Advisors and
Consultants Staff.
13
DR. RUDORFER: Dr.
Matthew
Rudorfer,
14 Acting Chief, Adult Interventions
Branch, National
15 Institute of Mental Health and
Chair of the