**PREGNANCY LABELING SUBCOMMITTEE OF THE**

**ADVISORY COMMITTEE FOR REPRODUCTIVE HEALTH DRUGS**

**CENTER FOR DRUG EVALUATION AND RESEARCH**

**March 28-29, 2000**

**Hilton Hotel**

**620 Perry Parkway, Gaithersburg, MD**

**[SUBCHAIRMAN]{.underline}**

**Greene, Michael F., M.D.**

**Associate Professor of Obstetrics,**

**Gynecology and Reproductive Biology**

**Department of Obstetrics and Gynecology**

**Massachusetts General Hospital**

**Founders Room 430**

**Boston, MA 02114**

**[ACTING EXECUTIVE SECRETARY]{.underline}**

**Sandra Titus, Ph.D.**

**Advisors and Consultants Staff, HFD-21**

**Center for Drug Evaluation and Research**

**Food and Drug Administration**

**5600 Fishers Lane**

**Rockville, Maryland 20857**

**301/827-7001 Fax: 301/827-6776**

**E-mail: tituss@cder.fda.gov**

[**SUBCOMMITTEE** **MEMBERS**]{.underline}:

**Andrews, Elizabeth, Ph.D., M.P.H.**

**Director**

**Worldwide Epidemiology**

**Glaxo Wellcome**

**5 Moore Drive, Box 13398**

**Research Triangle Park, NC**

**27709-2298**

**Conover, Elizabeth Ann, M.S.**

**Coordinator**

**Nebraska Teratogen Information Service**

**Munroe Meyer Institute for Genetics**

**and Rehabilitation**

**University of Nebraska Medical Center**

**985440 Nebraska Medical Center**

**Room 2074**

**Omaha, NE 68198-5440**

**Chambers, Christina, M.P.H.**

**Epidemiologist**

**California Teratogen Information Services**

**UCSD Medical Center**

**Department of Pediatrics**

**200 W. Arbor Drive**

**San Diego, CA 92103-8446**

**Cragan, Janet Darden, M.D.**

**Division of Birth Defects**

**and Genetics**

**National Center for Environmental**

**Health**

**Centers for Disease Control and**

**Prevention**

**MS F45, 4770 Buford Highway, NE.**

**Atlanta, GA 30341-3724**

**Hammond, Mary G. M.D.**

**Reproductive Endocrinologist**

**Reproductive Consultants, PA**

**1053 Fearrington Post**

**Pittsboro, NC 27312**

**Lemons, James A., M.D.**

**Professor of Pediatrics**

**Indiana University of Medicine**

**699 W. Drive, Bldg. RR208**

**Indianapolis, IN 46202**

**Mitchell, Allen, M.D.**

**Director**

**Slone Epidemiology Unit**

**Professor of Epidemiology and Pediatrics**

**Boston School of Public Health**

**and Medicine**

**1371 Beacon Street**

**Brookline, MA 02446**

**Montella, Karen Rosene, M.D.**

**Department of Medicine**

**Women & Infants Hospital**

**101 Dudley Street**

**Providence, RI 02905**

**Page 2**

**Weiss, Sheila, Ph.D.**

**Assistant Professor**

**University of Maryland**

**100 N. Greene Street, 6th Floor**

**Baltimore, MD 21201**

**Wier, Patrick, M.D.**

**Group Director**

**Reproductive Toxicology**

**SmithKline Beecham Pharmaceuticals**

**709 Swedeland Road, MC#UE0465**

**King of Prussia, PA 19406**

**Wisner, Katherine L., M.D.**

**Professor of Psychiatry and**

**Reproductive Biology**

**Director, Women=s Mental Health**

**Care Program**

**Case Western Reserve University**

**11400 Euclid Avenue**

**Triangle Bldg., Suite 280**

**Cleveland, OH 44106**

**[Consumer Representative]{.underline}:**

**Scott, Julia, R.N.**

**President**

**National Black Women=s Health Project**

**600 Pennsylvania Avenue, SE., Suite 310**

**Washington, D.C. 20003**

**[Non-Voting Consultants]{.underline}:**

**Birkhead, Guthrie, M.D., M.P.H.**

**Council of State and Territorial**

**Epidemiologists**

**NYS Department of Health Aids Institute**

**Corning Tower, Empire State Plaza**

**Room 412**

**Albany, NY 12237**

**Friedman, Jan M., M.D., Ph.D.**

**Birth Defects and Genetic**

**Diseases Branch**

**Centers for Disease Control (CDC)**

**4770 Buford Highway, N.E.**

**Mail Stop F-45**

**Atlanta, GA 30341-3724**

**Page 3**

**[Non-Voting Consultants]{.underline}: (cont.)**

**Jones, Ken Lyons, M.D.**

**Professor of Pediatrics**

**Department of Pediatrics**

**Division of Dysmorphology and Teratology University of California, San
Diego**

**200 West Arbor Drive, #8446**

**San Diego, CA 92103**

**King, Susan, M.D.**

**Division of Infectious Disease**

**The Hospital for Sick Children**

**555 University Avenue**

**Toronto, ON M5B 1X8 Canada**

**Mattison, Donald, M.D.**

**Medical Director**

**March of Dimes**

**Birth Defects Foundation**

**1275 Mamaroneck Avenue**

**White Plains, NY 10605**

**Mills, James, Ph.D.**

**Senior Investigator**

**National Institutes of Child Health**

**and Development**

**National Institutes of Health**

**6100 Executive Boulevard, Rm. 7B-03**

**Bethesda, MD 20892**

**Wade, Nancy, M.D., M.P.H.**

**Council of State and Territorial**

**Epidemiologists**

**NYS Department of Health Aids Institute**

**Corning Tower, Empire State Plaza**

**Room 412**

**Albany, NY 12237**

**Page 4**

**[Speakers]{.underline}:**

**Holmes, Lewis, M.D.**

**Professor of Pediatrics**

**Massachusetts General Hospital**

**Genetics & Teratology Unit**

**Waren 801**

**32 Fruit Street**

**Boston, MA 02114-2696**

**Rhodes, Phillip, Ph.D.**

**National Center for HIV, STD, and Prevention, Division of HIV/AIDS**

**Prevention, Center for Disease**

**for Disease Control and Prevention**

**1600 Clifton Road, N.E.**

**Atlanta, GA 30333**

**Rogers, Audrey, Ph.D.**

**Adolescent Medicine**

**HIV/AIDS Research Network**

**National Institutes of Child Health**

**and Human Development**

**6100 Executive Blvd.**

**Bethesda, MD 20892**

**Sharrar, Robert, M.D.**

**Merck and Company, Inc.**

**Sentry Parkway West**

**P.O. Box 4, BLB-30**

**Bldg. West, Mail Stop BLB-30**

**Blue Bell, PA 19422**

**Spong, Cathy, M.D.**

**National Institutes of Health**

**Pregnancy Branch**

**6100 Executive Blvd.**

**Bethesda, MD 20892**