From: DeMaria, Alfred (DPH) [Alfred.Demaria@state.ma.us] Sent: Monday, August 25, 2003 2:27 PM To: 'fdadockets@oc.fda.gov' Subject: Docket No. 75N-183H Re: Proposed Rule; Reopening of the Administrative Record for Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Health-Care Antiseptic Drug Products [Docket No. 75N-183H] I write in response to the above reopening of the administrative record in the matter of the proposed rule as Docket No. 75N-183H, published in the Federal Register (68 Fed. Reg. 32003, May 29, 2003). My comments are restricted to products that fall under 21 CFR §333.410(a)), Antiseptic Handwash/Health-Care Personnel Handwash, The 1994 tentative final monograph (TFM) for Over-the-Counter (OTC) Health-Care Antiseptic Drug Products, 59 Fed. Reg. 31402, June 17, 1994, as it stands, is contradictory to the intended use, proven health benefit and established efficacy of currently available, OTC alcohol-based hand rubs and gels. These products were not tested using the 1994 TFM method, and should not be tested by this method, nor do they need to meet the requirement of a 3-log reduction on tenth wash to accomplish their intended use. The TFM should be revised to reflect the current application of these products. Maintenance of the contradictory nature of the 1994 TFM will result in the removal of these proven products from the market. The safety and efficacy of alcohol-based hand antiseptics without residual antimicrobial effect in the healthcare setting are well-established (Bischoff, et al. Arch Intern Med. 2000; 160:1017-21. Boyce and Pittet, Infection Control and Hospital Epidemiology. 2002; 23(Suppl):S3-S40. Fendler, et al. American Journal of Infection Control. 2002; 30:226-233. Girard, et al. J Hosp Infect. 2001; 47:131-7. Guinan, et al. American Journal of Infection Control. 2002; 30:217-20. Hammond, et al. American Journal of Infection Control. 2000; 28:340 - 346. Harbarth, et al. Pediatr Infect Dis J. 2002; 21:489-95. Hugonnet, et al. Arch Intern Med. 2002;162:1037-43. Pittet, et al. Lancet. 2000; 356:1307-12. Pittet. J Hosp Infect. 2001;48 Suppl A:S40-6. Trick, et al. Clinical Infectious Disease. 2003; 36:1383-1390.). The 1994 TFM would require that such products have residual or persistent antimicrobial effect. Current products lack such persistent antimicrobial effect because they are used for the rapid decontamination of the hands and do not require such persistent effect for their intended use. Addition of persistent antimicrobials to these products will have negative consequences in regard to exposure of healthcare workers to cumulative doses of these persistent agents when the product are used as intended and will promote the emergence of organisms resistant to these agents, with the possibility of cross-resistance to other agents as well. Under the 1994 TFM, many products of proven efficacy, already on the market, will be removed. This will be detrimental to the goals of public health and will cause significant disruption in the health care delivery system. The health benefits of alcohol-based hand rubs and gels have been well-established. The 1994 TFM is not applicable to the intended uses of these products and needs to be revised for this class of products. This is a circumstance in which new data and information must inform a revision of the TFM so that the Final Monograph for Health-Care Antiseptics reflects the scientific evidence base supporting the use of alcohol-based products without the requirements of persistent or cumulative antimicrobial effect and with only a requirement for test performance limited to the first degerming application. Thank you for this opportunity to comment. Alfred DeMaria, Jr., M.D. Assistant Commissioner Director, Bureau of Communicable Disease Control State Epidemiologist Massachusetts Department of Public Health State Laboratory Institute 305 South Street Jamaica Plain, Massachusetts 02130 617-983-6550 Fax: 617-983-6925 Alfred.DeMaria@state.ma.us