Call to Order and Opening Remarks Linda Giudice, M.D., Ph.D.
Introductions Chair, ACRHD
Conflict of Interest Statement Jayne E. Peterson, R.Ph., J.D.
Acting Executive Secretary, ACRHD, FDA
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.
Folate Nutrition and Metabolism and Influence Barry Shane, Ph.D.
on Neural Tube Defects (NTDs) Professor, Dept. of Nutritional
Sciences and Toxicology
Folic Acid and Safety Patrick J. Stover, Ph.D.
Associate Professor of
Folic Acid Fortification in the
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
and Developmental Disabilities Centers for Disease Control
and Prevention (CDC)
Folic Acid Supplementation and Fortification Michiel Van den Hof, M.D.
What is the Minimum Effective Dose of Folic Acid James L. Mills, M.D., M.S.
for Preventing NTDs? Chief, Pediatric Epidemiology Section
Div. of Epidemiology, Statiststics and Prevention Research, NICHD, NIH
Questions to Speakers
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
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
Oral Contraceptive Use, Pregnancy Intendedness Andrew M. Kaunitz, M.D.
and Folic Acid Intake Professor and Assistant Chairman
Summary and Conclusion Andrew J. Friedman, M.D.
Questions to Speakers
Open Public Hearing
Presentation of Questions and Committee Discussion
Continuation of Committee Discussion