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Regulatory History of Healthcare Antiseptic Drug Products

Regulatory History of Healthcare Antiseptic Drug Products. Tia Frazier, R.N., M.S. Regulatory Project Manager Division of Over-the-Counter Drug Products. Labeled Uses-Health Care Antiseptic Drug Products . Includes 3 uses: Patient preoperative skin preparation Surgical hand scrubs

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Regulatory History of Healthcare Antiseptic Drug Products

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  1. Regulatory History of Healthcare Antiseptic Drug Products Tia Frazier, R.N., M.S. Regulatory Project Manager Division of Over-the-Counter Drug Products

  2. Labeled Uses-Health Care Antiseptic Drug Products Includes 3 uses: • Patient preoperative skin preparation • Surgical hand scrubs • Healthcare personnel handwashes

  3. Regulation of OTC Drugs • NDA (New Drug Application) • Drug product-specific • Confidential • Monograph • Active ingredient-specific • Public

  4. OTC Monographs • OTC Drug Monograph Review initiated in 1972 • > 200,000 OTC drug products • 700 active ingredients • 26 therapeutic categories

  5. Advisory Review Panel ANPR OTC Monographs

  6. TFM ANPR OTC Monographs Comments

  7. TFM FM TFM OTC Monographs Comments Data

  8. Current Views • Antiseptics are part of current infection control practice • Presumption: Decrease in organisms on skin surfaces decreases nosocomial infections Surrogate endpoint

  9. Measuring Effectiveness Surrogate endpoints (log reductions) established because of the difficulty in conducting clinical (in vivo) experiments (September 13, 1974 Advance Notice of Proposed Rulemaking p. 33410)

  10. Patient Preoperative Skin Preparation Effectiveness Criteria • 3 log reduction proposed for the patient pre-operative skin preparations (September 13, 1974-ANPR) • Included in January 6, 1978 TFM

  11. Surgical Hand Scrub Effectiveness Criteria • 1975-NDA approval for Hibiclens • 4% chlorhexidine gluconate surgical hand scrub • Based on surrogate model for surgical hand scrubs • Positive control

  12. Healthcare Personnel Handwash (HCPHW) Effectiveness Criteria • 3 log reduction proposed for HCPHWs TFM#2 (June 17, 1994) • Based on criteria used to approve NDA products

  13. Current TFM (June 17, 1994)a.k.a. TFM#2 • Refined testing requirements • In vitro testing • In vivo testing (clinical simulations) • Testing required for new formulations

  14. Current TFM (June 17, 1994) • Key attributes identified • Persistence • Low irritancy • Fast acting • Broad spectrum

  15. Public Input • Public meetings • July 29, 1998 - AC Meeting Topic: “Performance testing” • General discussion only, no vote taken • Nov. 3, 1999 Public Feedback Meeting-Topic:Healthcare Continuum Model proposed by industry coalition • Model proposes different standards

  16. FDA Data Evaluation FDA data evaluation on healthcare personnel handwashes, surgical hand scrubs, and patient preoperative skin preparations: • Industry Data Submission on Performance Criteria (122references) • Industry Data Submission on Clinical Benefit (155 references) • FDA’s Literature Survey on Clinical Benefit (>1,000 references)

  17. Next Steps • Feedback on the appropriate performance criteria • Feedback on design and testing requirements

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