Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee

Food and Drug Administration

Center for Drug Evaluation and Research

Holiday Inn, 8120 Wisconsin Ave., Bethesda, MD

GERD – Template

Agenda for June 11, 2002

8:00 Call to Order, Introductions: Joan P. Chesney, M.D., Chair

Meeting Statement: Thomas H. Perez, R.Ph., M.P.H., Executive Secretary

Opening Comments: Dianne Murphy, M.D.

8:15 Introduction to the PPI Written Request Template Hugo Gallo-Torres, M.D.

8:30 Pathologic Pediatric GER & Clinical Trial Design: Eric Hassall, M.D.
differences in infants < 1 & > 1 year

8:45 Clinical trial design related to studies of PPIs in the neonate Mark Hudak, M.D.
& premature infant

9:00 Ethical issues of using randomized, placebo-controlled withdrawal Benjamin Wilfond, M.D.
trial design in pediatrics

9:15 Open Public Hearing

9:45 Break

10:00 Introduction to Questions & Charge to the Subcommittee Dr. Victor Raczkowski

10:10 Discussion of Questions

12:00 Lunch

1:00 Introduction: Preliminary Priority List of Drugs Dr. Anne Willoughby

1:05 Background Dr. Rosemary Roberts

1:25 Development of the Preliminary Priority List of Drugs Dr. William Rodriguez

1:35 NIH’s Role in the Development of the Priority List Dr. Anne Willoughby

1:45 Discussion of Preliminary Priority List of Drugs Dr. Dianne Murphy

2:00 Open Public Hearing

2:30 Break

2:45 Presentation of Questions and Goals for Discussion Dr. Dianne Murphy

3:00 Discussion

4:30 Update from Europe Dr. Julia Dunne
Dr. Agnes St. Raymond

5:00 Rule and Exclusivity Update Peds Team

6:00 Close


Consultants (Voting)

Patricia Chesney, M.D., Professor of Pediatrics, University of Tennessee College of Medicine

Robert Fink, M.D., Chairman, Department of Allergy and Pulmonary Medicine, Children=s National Medical Center

Mark Hudak, M.D., Professor and Chief, Division of Neonatology, University of Florida at Jacksonville

Victor Santana, M.D., Associate Professor, Dept. of Hematology/Oncology, St. Jude=s Children=s Research Hospital

Naomi Luban, M.D., Vice Chairman, Department of Laboratory Medicine, Children=s National Medical Center

David Danford, M.D., Associate Professor of Pediatrics, University Nebraska Medical Center

Richard Gorman, M.D., FAAP, Pediatrician, Pediatric Partners

George D. Ferry, M.D., Professor of Pediatrics, Texas Children’s Hospital

Eric Hassall, MBChB FRCPC FACG, Division of Gastroenterology, BC Children's Hospital

Robert Nelson, M.D., Ph.D.,Associate Professor of Anesthesia & Pediatrics, The Children's Hospital of Philadelphia


Guests (Non-voting)

Benjamin Wilfond M.D., Bioethics Research Section,National Institutes of Health

Robert M. Ward, MD., Director, Pediatric Pharmacology Program, University of Utah

Harland Winter, MD., Director, Pediatric IBD Center, MassGeneral Hospital for Children

Ben Gold, M.D., Director, Division of Pediatric Gastroenterology & Nutrition, Emory University School Medicine

Lillian R. Blackmon, M.D. Clinical Associate Professor, Pediatrics, University of Maryland School of Medicine

Ralph E. Kauffman, M.D. Professor, Pediatric Pharmacology, Children’s Mercy Hospital

Laura James, M.D., Professor, Clinical Pharmacology, Arkansas Children’s Hospital

John T. Walkup, M.D., Professor Clinical Psychopharmacology, Johns Hopkins Hospital

Julia Dunne, M.D., National Expert seconded to the European Commission

Agnes Saint Raymond, M.D., Head of Sector Scientific Advice and Orphan Drugs, The European Agency for the Evaluation of Medicinal Products (EMEA)


Guest Industry Representatives (Non-voting)

Steven Spielberg, M.D., Johnson & Johnson Pharmaceutical