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
16
Psychopharmacologic Drugs Advisory Committee.
17
DR. CHESNEY: Joan Chesney,
Professor of
18 Pediatrics at the University of Tennessee in
19
Memphis, and at St. Jude's Children Research
20
Hospital, and the Pediatric Subcommittee.
21
DR. McGOUGH: Jim McGough,
Associate
22
Professor in Child and Adolescent Psychiatry at
23
UCLA and member of the Psychopharm Drugs Advisory
24
Committee.
DR.
25
GRADY-WELIKY: Tana Grady-Weliky,
Associate
11
1
Professor of Psychiatry at the University of
2
Rochester, School of Medicine and Dentistry, and
3
member of the Psychopharm Advisory Committee.
4
DR. WANG: Philip Wang,
psychiatrist and
5
epidemiologist, Harvard Medical School.
6
DR. O'FALLON: Judith O'Fallon, recently
7
retired from the Cancer Center Statistics Unit of
8 the
Mayo Clinic. I am a member of the
Pediatric
9
Subcommittee.
10
DR. NELSON: Robert Nelson,
Pediatric
11
Critical Care Medicine at the Children's Hospital,
12
Philadelphia.
13
DR. ANDREWS: Elizabeth Andrews,