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Regulatory History and Attributes of Consumer Antiseptics Nonprescription Drugs Advisory Committee Meeting Silver Spring, Maryland October 20, 2005 Colleen.

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Presentation on theme: "Regulatory History and Attributes of Consumer Antiseptics Nonprescription Drugs Advisory Committee Meeting Silver Spring, Maryland October 20, 2005 Colleen."— Presentation transcript:

1 Regulatory History and Attributes of Consumer Antiseptics Nonprescription Drugs Advisory Committee Meeting Silver Spring, Maryland October 20, 2005 Colleen Kane Rogers, PhD Division of Nonprescription Regulation Development Nonprescription Drugs Advisory Committee Meeting Silver Spring, Maryland October 20, 2005 Colleen Kane Rogers, PhD Division of Nonprescription Regulation Development Center for Drug Evaluation and Research

2 Nonprescription Drugs Advisory Committee October 20, 2005 2 Overview The Monograph Process Defining Consumer Antiseptics Attributes of Consumer Antiseptics Concerns Regarding Consumer Antiseptics The Monograph Process Defining Consumer Antiseptics Attributes of Consumer Antiseptics Concerns Regarding Consumer Antiseptics

3 Nonprescription Drugs Advisory Committee October 20, 2005 3 OTC Monograph Process Category I: GRASE (Generally Recognized As Safe and Effective) Category II: not GRASE Category III: cannot determine if safe and effective Category I: GRASE (Generally Recognized As Safe and Effective) Category II: not GRASE Category III: cannot determine if safe and effective Advisory Review Panel

4 Nonprescription Drugs Advisory Committee October 20, 2005 4 OTC Monograph Process Category I: GRASE Category II: not GRASE Category III: cannot determine if safe and effective Category I: GRASE Category II: not GRASE Category III: cannot determine if safe and effective ANPR

5 Nonprescription Drugs Advisory Committee October 20, 2005 5 OTC Monograph Process ANPR TFM Comments

6 Nonprescription Drugs Advisory Committee October 20, 2005 6 OTC Monograph Process TFM Comments Data FM

7 Nonprescription Drugs Advisory Committee October 20, 2005 7 Antiseptic Monograph 1972 – Advisory Review Panel 1974 – Advance Notice of Proposed Rulemaking (ANPR) 1978 – Proposed Rule (TFM) 1994 – Proposed Rule (Amended TFM) Final Rule (FM) 1972 – Advisory Review Panel 1974 – Advance Notice of Proposed Rulemaking (ANPR) 1978 – Proposed Rule (TFM) 1994 – Proposed Rule (Amended TFM) Final Rule (FM)

8 Nonprescription Drugs Advisory Committee October 20, 2005 8 Antiseptic vs. Disinfectant Antiseptic –Antimicrobial used on the skin –Regulated by FDA Disinfectant –Antimicrobial used on inanimate objects or surfaces –Regulated by EPA Antiseptic –Antimicrobial used on the skin –Regulated by FDA Disinfectant –Antimicrobial used on inanimate objects or surfaces –Regulated by EPA

9 Nonprescription Drugs Advisory Committee October 20, 2005 9 Consumer Antiseptics Consumer products are currently marketed as: –Antibacterial soaps –Antibacterial wipes –Antibacterial bodywashes –Hand sanitizers Consumer products are currently marketed as: –Antibacterial soaps –Antibacterial wipes –Antibacterial bodywashes –Hand sanitizers

10 Nonprescription Drugs Advisory Committee October 20, 2005 10 Defining Consumer Antiseptics – FDA Panel defined ‘antimicrobial soap’: –Reduces the microbial flora of the skin –May reduce residents and transients 1978 TFM: intended for the general public in non-hospital settings 1994 TFM: called ‘antiseptic handwash’ Panel defined ‘antimicrobial soap’: –Reduces the microbial flora of the skin –May reduce residents and transients 1978 TFM: intended for the general public in non-hospital settings 1994 TFM: called ‘antiseptic handwash’

11 Nonprescription Drugs Advisory Committee October 20, 2005 11 Labeling Claims 1974 ANPR and 1978 TFM: –Antimicrobial/ antibacterial soap –Deodorant soap/ reduces odor 1978 TFM: –Different uses require different labeling for consumers and healthcare personnel –Insufficient data to accept claims for ‘prevention of infection’ 1974 ANPR and 1978 TFM: –Antimicrobial/ antibacterial soap –Deodorant soap/ reduces odor 1978 TFM: –Different uses require different labeling for consumers and healthcare personnel –Insufficient data to accept claims for ‘prevention of infection’

12 Nonprescription Drugs Advisory Committee October 20, 2005 12 Labeling Claims 1994 TFM: –Antiseptic/ antiseptic handwash –For handwashing to decrease bacteria on the skin After changing diapers After assisting ill persons –Recommended for repeated use 2003 Citizen Petition (SDA/CTFA): –Request anti-viral claims 1994 TFM: –Antiseptic/ antiseptic handwash –For handwashing to decrease bacteria on the skin After changing diapers After assisting ill persons –Recommended for repeated use 2003 Citizen Petition (SDA/CTFA): –Request anti-viral claims

13 Nonprescription Drugs Advisory Committee October 20, 2005 13 Defining Consumer Antiseptics – Industry 1994 TFM –3 healthcare categories –1 consumer category 1995 Healthcare Continuum Model –3 healthcare categories –2 consumer categories –1 food handler category 1994 TFM –3 healthcare categories –1 consumer category 1995 Healthcare Continuum Model –3 healthcare categories –2 consumer categories –1 food handler category