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Meeting of the Advisory Committee for Reproductive Health Drugs January 23 and 24, 2007

Meeting of the Advisory Committee for Reproductive Health Drugs January 23 and 24, 2007. Scott Monroe, MD Acting Director, Division of Reproductive and Urologic Products. Scope and Purpose of Meeting. Scope

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Meeting of the Advisory Committee for Reproductive Health Drugs January 23 and 24, 2007

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  1. Meeting of the Advisory Committee for Reproductive Health DrugsJanuary 23 and 24, 2007 Scott Monroe, MDActing Director, Division of Reproductive and Urologic Products

  2. Scope and Purpose of Meeting • Scope • General meeting on oral and non-oral (i.e., transdermal and intravaginal) hormonal contraceptive products • Objectives • Obtain advice on issues that need to be satisfactorily addressed during regulatory review prior to approval • Obtain advice to assist Division in developing a clinical trial Guidance Document for hormonal contraceptives • Currently no FDA clinical trial Guidance Document for these products

  3. Topics to be Discussed • Clinical trial design issues • Assessment of contraceptive efficacy and overall risk/benefit • Translation of clinical trial findings of efficacy and safety into “real world” effectiveness and safety • Cycle control (scheduled and unscheduled bleeding or spotting) and other measures of product acceptability to the user

  4. Topics to be Discussed • Extended dosing regimens • Post-approval (Phase 4) commitments for further investigation • Generally for uncommon but serious safety issues • Role and impact of labeling for communication of clinical trial findings to include • Product efficacy, risk, and other potential benefits

  5. Agenda (Day 1) 9:00 Clinical Trial Design Issues (Dr. Price) 11:00 Break 11:15 Efficacy and Risk/Benefit (Drs. Trussell/Gillen) 12:30 Lunch 1:30 Continue Discussion of Morning Topics 2:45 Break 3:00 Translation of Clinical Trial Findings to the “Real World” (Drs. Gilliam and Hillard) 5:00 Bleeding/Spotting Issues (Dr. Trussell) 6:00 Adjournment

  6. Agenda (Day 2) Extended Dosing Regimens Phase 4 Commitments Role and Impact of Labeling Presentations by Organizations and Individuals

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