Nonprescription Drugs Advisory Committee Meeting

October 20, 2005


Benefits and hazards of antiseptic products marketed for consumer use

(e.g., antibacterial hand-washes and body-washes)



Welcome and Introductory Comments                          Susan S. Johnson, Ph.D., Acting Director

Division of Nonprescription Regulation

Development, Office of Nonprescription Products, CDER

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Regulatory History and Attributes                                  Colleen Rogers, Ph.D., Microbiologist

of Consumer Antiseptic Drug Products                          Division of Nonprescription Regulation

Development, ONP, CDER

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Clinical Benefit of Consumer                                         Steven Osborne, M.D., Medical Officer

Antiseptics                                                                    Division of Nonprescription Clinical Evaluation


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Community-based Studies of                                        Allison E. Aiello, Ph.D., M.S., Assistant Professor

Consumer Antiseptics                                                   Center for Social Epidemiology & Population Health

Department of Epidemiology

University of Michigan School of Public Health

Ann Arbor, MI

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The Potential for Antibiotic/                                           Stuart B. Levy, M.D., Professor

Biocide Cross-resistance                                              Department of Molecular Biology & Microbiology

Tufts University School of Medicine

Boston, MA

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Secondary Routes of Exposure                                     Rolf U. Halden, Ph.D., P.E., Assistant Professor

to Biocides                                                                   Center for Water and Health

Department of Environmental Health Sciences

                                                                                    Johns Hopkins Bloomberg School of Public Health

                                                                                    Baltimore, MD

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EPA Regulatory Process for                                         Mark Hartman, Branch Chief

Antimicrobials                                                               Regulatory Management Branch

Antimicrobials   Division

                                                                                    Environmental Protection Agency

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Laboratory Studies:  Resistance/                                   Peter Gilbert, B.Sc., Ph.D.

Cross-resistance Development in                                  Professor of Microbial Physiology

Microcosm Communities                                              School of Pharmacy and Pharmaceutical Sciences

                                                                        University of Manchester, UK

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Environmental Safety of Active                                      Dr. Richard Reiss

Pharmaceutical Ingredients                                            Sciences International, Inc.

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The Case for Infection Control                                      Elizabeth Scott, Ph.D.

Practices in Home and Community                                Co-director Simmons College Center for Hygiene

Setting                                                                          and Health in Home and Community Settings

                                                                        Scientific board member of the International

                                                                        Forum on Home Hygiene

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Role of Hand Hygiene in Preventing                              David Jay Weber, M.D., M.P.H.

Transmission of Infectious Diseases                               Medical Director, Hospital Epidemiology

                                                                        Professor of Medicine, Pediatrics & Epidemiology

                                                                        University of North Carolina at Chapel Hill

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Importance of Fomites in the                                         Charles P. Gerba

Transmission of Infectious Diseases                               Department of Soil, Water and Environmental

                                                                        Science and Epidemiology and Biostatics

                                                                        University of Arizona

                                                                        Tucson, AZ

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Open Public Hearing Speakers

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                                                                        Sally Bloomfield, Bpharm, PhD

                                                                        Chairman and Acientific Advisory Board Member, IFH

                                                                        Hon. Professor, London School of Hygiene and Tropical Medicine

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                                                                                    Lawton Seal, PhD

                                                                                    Sr. Program Manager, Healthpoint R&D

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                                                                                    Charles N. Haas

                                                                                    Drexel University

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Eugene C. Cole, DrPH

Brigham Young University

Provo, Utah

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