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Regulatory History and Attributes of Consumer Antiseptics

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. Center for Drug Evaluation and Research. Overview.

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Regulatory History and Attributes of Consumer Antiseptics

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  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 Center for Drug Evaluation and Research

  2. Overview • The Monograph Process • Defining Consumer Antiseptics • Attributes of Consumer Antiseptics • Concerns Regarding Consumer Antiseptics

  3. Advisory Review Panel OTC Monograph Process • Category I: GRASE (Generally Recognized As Safe and Effective) • Category II: not GRASE • Category III: cannot determine if safe and effective

  4. ANPR OTC Monograph Process • Category I: GRASE • Category II: not GRASE • Category III: cannot determine if safe and effective

  5. ANPR TFM OTC Monograph Process Comments

  6. TFM FM OTC Monograph Process Comments Data

  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)

  8. Antiseptic vs. Disinfectant • Antiseptic • Antimicrobial used on the skin • Regulated by FDA • Disinfectant • Antimicrobial used on inanimate objects or surfaces • Regulated by EPA

  9. Consumer Antiseptics • Consumer products are currently marketed as: • Antibacterial soaps • Antibacterial wipes • Antibacterial bodywashes • Hand sanitizers

  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’

  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’

  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

  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

  14. Active Ingredients Used in Consumer Antiseptics • Ethanol • Triclosan • Triclocarban • Quaternary ammonium compounds • Benzalkonium chloride • Benzethonium chloride

  15. Proposed Consumer Antiseptic “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

  16. Proposed Consumer Antiseptic “Handwash” Attributes – Industry • Attributes: • Broad spectrum • Fast-actingnot essential • Persistent • Recommended efficacy testing: • Single wash to demonstrate efficacy • No cumulative effect

  17. Proposed Consumer Antiseptic Bodywash 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

  18. Potential Hazards from Using Consumer Antiseptics • Individual • Irritation • Contact dermatitis • Antibiotic resistance • Incomplete immune system ‘education’ • Societal • Antibiotic resistance • Impact on ecosystems • Secondary exposure

  19. Concerns 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

  20. Concerns 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

  21. Current FDA Concerns • Antibiotic and antiseptic cross-resistance • Environmental concerns • Secondary exposure • Impact on ecosystems

  22. 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?

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