Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee


Food and Drug Administration

Center for Drug Evaluation and Research

Hilton, The Ballrooms, 620 Perry Parkway, Gaithersburg, MD.


Clinical Risk Management of HPA Axis Suppression in Children

with Atopic Dermatitis being treated with Topical Corticosteroids



Draft Agenda for October 29, 2003


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.

Director, Office of Counter-terrorism and Pediatric Drug Development


                                                                                                                                Jonathan Wilkin, M.D.

                                                                                                                                Director, Division of Dermatologic

                                                                                                                and Dental Drug Products


8:30         Atopic Dermatitis:  Its Clinical Course                                   Bindi Nikhar, M.D.

                and Therapeutic Options                                                                  Division of Dermatologic and

Dental Drug Products


9:00                Overview of HPA Axis Suppression                                         Jean Temeck, M.D.

                                                                                                                                Division of Pediatric Drug



9:40         FDA Experience:  Topical Corticosteriods                                    Denise Cook, M.D.

                and HPA Axis Suppression                                                                Division of Dermatologic and

Dental Drug Products


10:10       Post Marketing Adverse Event Reports                                  ODS Staff


10:20       Q & A of Speakers


10:35       Break


10:50                Discussion of Question 1


11:10                Framework for Risk Assessment and Management                Anne Trontell, M.D.

                                                                                                                                Office of Drug Safety


11:30       Q & A of Speakers                                                                         


11:45       Lunch


12:45       Open Public Hearing


1:45                Discussion of Questions 2-4 and Wrap Up


3:30         Break


Section 17, Best Pharmaceuticals for Children Act, Adverse Event Reporting


3:45         Adverse Event Reports per Section 17 of BPCA                    Solomon Iyasu, M.D.

                                                                                                                                Division of Pediatric

Drug Development


4:30         Open Public Hearing


5:00                Committee Discussion of Presentations


5:30         Adjourn