Regulatory History of Healthcare Antiseptic Drug Products

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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