Food and Drug Administration        

Center for Drug Evaluation and Research (CDER)


Advisory Committee for Reproductive Health Drugs (ACRHD)


December 15, 2003


Hilton Grand Ballroom

620 Perry Parkway, Gaithersburg, MD




8:00       Call to Order and Opening Remarks                              Linda Giudice, M.D., Ph.D.

Introductions                                                                   Chair, ACRHD


8:10       Conflict of Interest Statement                                       Jayne E. Peterson, R.Ph., J.D.

                                                                                                         Acting Executive Secretary, ACRHD, FDA


8:20       Opening Remarks                                                            Daniel  Shames, M.D.

Director, Div. of Reproductive and

  Urologic Drug Products  (DRUDP), FDA


Issue:  The public health issues, including the safety and potential clinical benefit, associated with combining folic acid and an oral contraceptive into a single combination product. 


8:30       FDA Presentations

               Folate Nutrition and Metabolism and Influence           Barry Shane, Ph.D.

                  on Neural Tube Defects (NTDs)                                 Professor, Dept. of Nutritional

Sciences and Toxicology

University of California, Berkeley


Folic Acid and Safety                                                      Patrick J. Stover, Ph.D.

                                                                                                         Associate Professor of

                                                                                                         Nutritional Biochemistry

                                                                                                         Cornell University


               Folic Acid Fortification in the U.S.:                                            Elizabeth Yetley, Ph.D.

               Planning, Implementation, and Monitoring                  Lead Scientist for Nutrition

Center for Food Safety and

Applied Nutrition (CFSAN), FDA  


               Assessing the Impact of Fortification on the                              Joe Mulinare, M.D., MSPH

               Epidemiology of NTDs                                                  National Center on Birth Defects

and Developmental Disabilities                                     Centers for Disease Control

                                                                                                         and Prevention (CDC)


               Folic Acid Supplementation and Fortification             Michiel Van den Hof, M.D.

               in Nova Scotia                                                                 Division Head, Maternal/Fetal Medicine

                                                                                                         Dalhousie University

                                                                                                         Halifax, Nova Scotia


What is the Minimum Effective Dose of Folic Acid   James L. Mills, M.D., M.S.

               for Preventing NTDs?                                                                      Chief, Pediatric Epidemiology Section

Epidemiology Branch

Div. of Epidemiology, Statiststics and Prevention Research, NICHD, NIH


Advisory Committee for Reproductive Health Drugs (ACRHD)


December 15, 2003


Hilton Grand Ballroom

620 Perry Parkway, Gaithersburg, MD


AGENDA (cont.)


10:00     Questions to Speakers


10:15     Break


10:30     Invited Sponsor Presentations (Johnson and Johnson, Pharaceutical Research & Development, L.L.C.)

               Proposal Background and Overview                              Andrew J. Friedman, M.D.

Director, Women’s Health Care Research Ortho-McNeil Pharmaceutical, Inc.


Neural Tube Defects:  Efficacy and Safety of              Godfrey P. Oakley, Jr., M.D., MSPM

Folic Acid                                                                      Visiting Professor, Dept. of Epidemiology

                                                                                       Rollins School of Public Health

                                                                                       Emory University


Need for Increased Folic Acid Intake Among              Anna Maria Siega-Riz, Ph.D., R.D.

               Reproductive Age Women                                                            Associate Professor of Maternal and Child

Health and Nutrition

University of North Carolina at Chapel Hill


Oral Contraceptive Use, Pregnancy Intendedness       Andrew M. Kaunitz, M.D.

and Folic Acid Intake                                                      Professor and Assistant Chairman

                                                                                          University of Florida Health Science Center


               Summary and Conclusion                                               Andrew J. Friedman, M.D.


12:00     Questions to Speakers


12:15     Lunch


1:15       Open Public Hearing


2:15       Presentation of Questions and Committee Discussion


3:15       Break


3:30       Continuation of Committee Discussion


5:00       Adjourn