Food and Drug Administration

Center for Drug Evaluation and Research

Drug Safety and Risk Management Advisory Committee (DSaRM)

in joint session with the

Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC)

Hilton, 620 Perry Parkway, Gaithersburg, Maryland

Agenda February 26, 2004

8:00 Call to Order and Opening Remarks Peter Gross, M.D.

Chair, DSaRM

Introduction of Committee

Conflict of Interest Statement Shalini Jain, PA-C, M.B.A.

Executive Secretary, DSaRM

Effectiveness of the isotretinoin risk management program

for the prevention of fetal exposure to Accutane and its generic equivalents

and

consideration of whether changes to this isotretinoin risk management program

would be appropriate

8:15 Charge to the Committees Steven Galson, M.D., M.P.H.

Acting Director, Center for Drug Evaluation

and Research (CDER)

8:30 Background and Regulatory History Jill Lindstrom, M.D.

Medical Officer

Division of Dermatologic and Dental Drug

Products, FDA

Questions to the Speaker from Committee

9:30 Open Public Hearing

9:40 Hoffmann-La Roche, Inc. Presentations Joanna Waugh

Group Director, Regulatory Affairs

Martin H. Huber, M.D.

Vice President, Global Head Drug Safety Risk Management

Susan Ackermann Shiff, Ph.D.

Global Head Risk Management, Drug Safety Risk Management

Food and Drug Administration

Center for Drug Evaluation and Research

Drug Safety and Risk Management Advisory Committee (DSaRM)

in joint session with the

Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC)

Agenda (cont.) February 26, 2004

10:30 Generic Firms' Presentations

Isotretinoin Risk Management Program - Frank R. Sisto, Vice President

Background Information Corporate Regulatory Affairs

Mylan Laboratories Inc.

Isotretinoin Survey Allen A. Mitchell, M.D., Director

Slone Epidemiology Center

Boston University

Isotretinoin Enhanced Risk Management Program Robert W. Pollock, Vice President

- Program Elements for Which Advisory Committee Lachman Consultant Services Inc.

Input is Requested

Questions to Roche and Generic Firms from Committee

11:45 Lunch

1:00 Isotretinoin Pregnancy Exposure: Marilyn Pitts, Pharm.D.

Spontaneous Reports 1-Year pre and Safety Evaluator, FDA

1-Year post-Risk Management Program Pharmacist

Isotretinoin Pregnancy Prevention Allen Brinker, M.D., M.S.

Program Evaluation Lead Medical Officer, Epidemiology, FDA

2:00 Kaiser Presentation Richard A. Wagner, Pharm.D.
Leader
Kaiser Permanente Drug Use Management

Questions to Kaiser from the Committee

2:30 Organization of Teratology Information Services Richard Miller, Ph.D.

(OTIS), Interim Report, North American Professor and Associate Chair of

Isotretinoin Information and Survey Line Obstetrics and Gynecology

Questions to OTIS from the Committee

3:00 Break

3:15 Risk Management Options for Kathleen Uhl, M.D.

Pregnancy Prevention Pregnancy Labeling Team, FDA

Selecting Risk Management Tools:  Anne Trontell, M.D., M.P. H.

Considerations and Experience Deputy Director

Office of Drug Safety, FDA

Questions to Speakers from the Committee

5:30 Adjourn

Food and Drug Administration

Center for Drug Evaluation and Research

Drug Safety and Risk Management Advisory Committee (DSaRM)

in joint session with the

Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC)

Hilton, 620 Perry Parkway, Gaithersburg, Maryland

Agenda February 27, 2004

8:00 Call to Order and Opening Remarks Peter Gross, M.D.

Chair, DSaRM

Conflict of Interest Statement Kimberly Topper, M.S.

Executive Secretary, DODAC

Effectiveness of the isotretinoin risk management program

for the prevention of fetal exposure to Accutane and its generic equivalents

and

consideration of whether changes to this isotretinoin risk management program would be appropriate

8:30 Open Public Hearing

9:40 Break

10:00 Introduction of Questions Paul Seligman, M.D., M.P.H.

Director, Office of Pharmacoepidemiology

and Statistical Science, FDA

10:20 Committee Discussion

12:00 Lunch

1:00 Committee Discussion

5:00 Adjourn