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Regulatory History of Healthcare Antiseptic Drug Products
Tia Frazier, R.N., M.S.Regulatory Project Manager
Division of Over-the-Counter Drug Products
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Labeled Uses-Health Care Antiseptic Drug Products
Includes 3 uses:• Patient preoperative skin preparation
• Surgical hand scrubs
• Healthcare personnel handwashes
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Regulation of OTC Drugs
• NDA (New Drug Application)– Drug product-specific– Confidential
• Monograph– Active ingredient-specific– Public
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OTC Monographs
• OTC Drug Monograph Review initiated in 1972
• > 200,000 OTC drug products
• 700 active ingredients
• 26 therapeutic categories
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OTC Monographs
Advisory Review Panel
ANPR
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OTC Monographs
ANPR
TFM
Comments
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OTC Monographs
TFM
Comments
Data
FM
TFM
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Current Views
• Antiseptics are part of current infection control practice
• Presumption: Decrease in organisms on skin surfaces decreases nosocomial infections
Surrogate endpoint
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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)
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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
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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
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Healthcare Personnel Handwash Healthcare Personnel Handwash (HCPHW) Effectiveness Criteria(HCPHW) Effectiveness Criteria
• 3 log reduction proposed for HCPHWs TFM#2 (June 17, 1994)
• Based on criteria used to approve NDA products
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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
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Current TFM (June 17, 1994)
• Key attributes identified– Persistence
– Low irritancy
– Fast acting
– Broad spectrum
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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
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FDA Data Evaluation
FDA data evaluation on healthcare personnel handwashes, surgical hand scrubs, and patient preoperative skin preparations:
• Industry Data Submission on Performance Criteria (122 references)
• Industry Data Submission on Clinical Benefit (155 references)
• FDA’s Literature Survey on Clinical Benefit (>1,000 references)
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Next Steps
• Feedback on the appropriate performance criteria
• Feedback on design and testing requirements