regulatory history and attributes of consumer antiseptics nonprescription drugs advisory committee...
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Regulatory History and Attributes Regulatory History and Attributes of Consumer Antisepticsof Consumer AntisepticsRegulatory History and Attributes Regulatory History and Attributes of Consumer Antisepticsof Consumer Antiseptics
Nonprescription Drugs Advisory Nonprescription Drugs Advisory Committee MeetingCommittee Meeting
Silver Spring, MarylandSilver Spring, MarylandOctober 20, 2005October 20, 2005
Colleen Kane Rogers, PhD Colleen Kane Rogers, PhD Division of Nonprescription Regulation DevelopmentDivision of Nonprescription Regulation Development
Nonprescription Drugs Advisory Nonprescription Drugs Advisory Committee MeetingCommittee Meeting
Silver Spring, MarylandSilver Spring, MarylandOctober 20, 2005October 20, 2005
Colleen Kane Rogers, PhD Colleen Kane Rogers, PhD Division of Nonprescription Regulation DevelopmentDivision of Nonprescription Regulation Development
Center for Drug Evaluation and ResearchCenter for Drug Evaluation and Research
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OverviewOverview
• 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
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OTC Monograph Process OTC Monograph Process
OTC Monograph Process 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
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OTC Monograph ProcessOTC Monograph ProcessOTC Monograph ProcessOTC 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
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OTC Monograph ProcessOTC Monograph ProcessOTC Monograph ProcessOTC Monograph Process
ANPRTFM
Comments
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OTC Monograph ProcessOTC Monograph ProcessOTC Monograph ProcessOTC Monograph Process
TFM
Comments
Data
FM
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Antiseptic MonographAntiseptic MonographAntiseptic MonographAntiseptic 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)
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Antiseptic vs. DisinfectantAntiseptic vs. DisinfectantAntiseptic vs. DisinfectantAntiseptic 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
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Consumer AntisepticsConsumer AntisepticsConsumer AntisepticsConsumer 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
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Defining Consumer Antiseptics – Defining Consumer Antiseptics – FDAFDA
Defining Consumer Antiseptics – Defining Consumer Antiseptics – FDAFDA
• 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’
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Labeling ClaimsLabeling ClaimsLabeling ClaimsLabeling 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’
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Labeling ClaimsLabeling ClaimsLabeling ClaimsLabeling 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
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Defining Consumer Antiseptics – Defining Consumer Antiseptics – IndustryIndustry
Defining Consumer Antiseptics – Defining Consumer Antiseptics – IndustryIndustry
• 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
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Active Ingredients Used in Active Ingredients Used in Consumer AntisepticsConsumer Antiseptics
Active Ingredients Used in Active Ingredients Used in Consumer AntisepticsConsumer Antiseptics
• Ethanol • Triclosan• Triclocarban • Quaternary ammonium compounds
– Benzalkonium chloride– Benzethonium chloride
• Ethanol • Triclosan• Triclocarban • Quaternary ammonium compounds
– Benzalkonium chloride– Benzethonium chloride
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Proposed Consumer Antiseptic Proposed Consumer Antiseptic “Handwash” Attributes – FDA“Handwash” Attributes – FDA
Proposed Consumer Antiseptic Proposed Consumer Antiseptic “Handwash” Attributes – FDA“Handwash” Attributes – FDA
• Attributes:– Broad spectrum – Fast-acting – Persistent (if possible)
• Recommended efficacy testing:– Same as healthcare personnel handwashes – Specific bacterial reductions after 1st and
10th washes
• Attributes:– Broad spectrum – Fast-acting – Persistent (if possible)
• Recommended efficacy testing:– Same as healthcare personnel handwashes – Specific bacterial reductions after 1st and
10th washes
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Proposed Consumer Antiseptic Proposed Consumer Antiseptic “Handwash” Attributes – Industry“Handwash” Attributes – IndustryProposed Consumer Antiseptic Proposed Consumer Antiseptic
“Handwash” Attributes – Industry“Handwash” Attributes – Industry
• Attributes:– Broad spectrum – Fast-acting not essential– Persistent
• Recommended efficacy testing:– Single wash to demonstrate efficacy– No cumulative effect
• Attributes:– Broad spectrum – Fast-acting not essential– Persistent
• Recommended efficacy testing:– Single wash to demonstrate efficacy– No cumulative effect
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Proposed Consumer Antiseptic Proposed Consumer Antiseptic Bodywash Attributes – IndustryBodywash Attributes – IndustryProposed Consumer Antiseptic Proposed Consumer Antiseptic Bodywash Attributes – IndustryBodywash Attributes – Industry
• Attributes:– Limited or broad spectrum – Fast-acting not essential– Persistent
• Recommended efficacy testing:– Significant reduction in resident flora
compared to baseline – OR –– Significant reduction in transient flora
compared to use of placebo/ bland soap
• Attributes:– Limited or broad spectrum – Fast-acting not essential– Persistent
• Recommended efficacy testing:– Significant reduction in resident flora
compared to baseline – OR –– Significant reduction in transient flora
compared to use of placebo/ bland soap
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Potential Hazards from Using Potential Hazards from Using Consumer AntisepticsConsumer Antiseptics
Potential Hazards from Using Potential Hazards from Using Consumer AntisepticsConsumer Antiseptics
• Individual – Irritation– Contact dermatitis– Antibiotic resistance– Incomplete immune system ‘education’
• Societal– Antibiotic resistance– Impact on ecosystems– Secondary exposure
• Individual – Irritation– Contact dermatitis– Antibiotic resistance– Incomplete immune system ‘education’
• Societal– Antibiotic resistance– Impact on ecosystems– Secondary exposure
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Concerns Raised by the 1972 PanelConcerns Raised by the 1972 PanelConcerns Raised by the 1972 PanelConcerns Raised by the 1972 Panel
• Routine use of antimicrobials may have a long-term harmful effect by reducing normal flora (hypothetical)
• Widespread use of antibiotics, antiseptics, and hard surface disinfectants may produce an increase in gram-negative infections
• Exposure of the entire body to antimicrobial chemicals when alternate methods of odor control are available
• Routine use of antimicrobials may have a long-term harmful effect by reducing normal flora (hypothetical)
• Widespread use of antibiotics, antiseptics, and hard surface disinfectants may produce an increase in gram-negative infections
• Exposure of the entire body to antimicrobial chemicals when alternate methods of odor control are available
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Concerns Raised by FDAConcerns Raised by FDAConcerns Raised by FDAConcerns Raised by FDA
• Proliferation of triclosan-containing products– In 1994 TFM, based on new information,
concluded that proliferation was not a concern
• Antibiotic and antiseptic resistance related to healthcare antiseptics (1997 NDAC)– Decreased susceptibility to antiseptics was
not a concern at that time– Recommended surveillance
• Proliferation of triclosan-containing products– In 1994 TFM, based on new information,
concluded that proliferation was not a concern
• Antibiotic and antiseptic resistance related to healthcare antiseptics (1997 NDAC)– Decreased susceptibility to antiseptics was
not a concern at that time– Recommended surveillance
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Current FDA Concerns Current FDA Concerns Current FDA Concerns Current FDA Concerns
• Antibiotic and antiseptic cross-resistance
• Environmental concerns
– Secondary exposure– Impact on ecosystems
• Antibiotic and antiseptic cross-resistance
• Environmental concerns
– Secondary exposure– Impact on ecosystems
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What Do We Need to Know?What Do We Need to Know?What Do We Need to Know?What Do We Need to Know?
• Finalizing the Monograph• Need NDAC input to develop some
policies– What population would benefit from
consumer antiseptics?– How do we measure the benefit of
these products?– Which potential hazards, if any, pose
a concern?
• Finalizing the Monograph• Need NDAC input to develop some
policies– What population would benefit from
consumer antiseptics?– How do we measure the benefit of
these products?– Which potential hazards, if any, pose
a concern?