CABF Pepsi Project fundraiser: 2002 plea to FDA supported pediatric exclusivity incentives

CABF supports off-label use of psychiatric medications for children

Child &Adolescent Bipolar Foundation 2002

EXECUTIVE DIRECTOR
Martha Hellander, J.D.
PRESIDENT

Ruth Field

BOARD OF DIRECTORS

Ann Baumbach

Robert Field, C.P.A., C.F.P.

Barbara Geller, M.D.

Dorie Geraci, MS., R.N.

Marjorie Kitzes, M.Ed.

Tricia Kratz

Marcie Lipsitt

William MacDonald, C.P.A. (founding member in 1999 & tax preparer )

Ellen Solms

Susan R.F. Solomon, J.D.

MuffyWaiker, R.N., M.S.N.

PROFESSIONAL
ADVISORY BOARD

Chair

Barbara Geller, M.D.

Ross J. Baldessarini, M.D.

Joseph Biederman, M.D.

Kiki D. Chang, M.D.

Edwin H. Cook, Jr., M.D.

Andrea Eberle, M.D.

Gianni L. Faedda, M.D.

Robert L. Findling, M.D.

David Horrobin, M.D., Ph.D.

Kay Redfield Jamison, Ph.D.

Vivian Kafantaris, M.D.

Robert A. Kowatch, M.D.

Neal D. Ryan, M.D.

P.M.B. 331
1187 Wilmette Avenue
Wilmette, Illinois 60091

(847) 256-8525
(847) 920-9498 Fax
email: cabf@bpkids.org

CABF is a not-for-profit
organization. Contributions
may be tax-deductible.


July 8,2002

JULY 2002 Letter to the FDA


Food and Drug Administration

Fishers Lane, Room 1061
Rockville, MD 20852


Re: Obtaining Timely Pediatric Studies of an Adequate Pediatric Labeling
for Human Drugs and Biologics

..."CABF supports maintaining pediatric exclusivity incentives"...


..."medications designed to treat orphan conditions (such as pediatric mania) should be accepted for inclusion on the Pediatric List and be eligible for NIH funding in a manner to generic products."