CTFA Antiseptic Log Reduction Criteria Will Be Topic Of NDAC Meeting

A request from the Cosmetic, Toiletry and Fragrance Association to FDA's Division of Over-The-Counter Drug Products to consider reducing the current log reduction criteria used to measure the efficacy of topical antiseptic products will be discussed at a March 23 meeting of the Nonprescription Drugs Advisory Committee in Gaithersburg, Md.

The OTC division is seeking input from the advisory committee on the current standards for evaluating efficacy of topical antiseptics for health care, including healthcare personnel hand washes, patient preoperative skin preparations and surgical hand scrubs.

NDAC will consider whether information provided by CTFA and manufacturers is sufficient to lower the log reduction criteria, according to a briefing document from the Center for Drug Evaluation & Research outlining discussion topics.

"Is the antiseptic activity of a product adequately described by bacterial log reduction? What level of bacterial load should be considered an adequately challenging baseline? Should the post-treatment bacterial load (residual bacteria) be considered in efficacy assessment?" FDA asks NDAC.

The agency also asks NDAC to consider if active and vehicle controls should be considered in efficacy assessments for healthcare antiseptics, and if so, if the bacterial reduction response to the test product and controls should be compared to determine efficacy.

Log reduction measures an antibacterial product's ability to produce specified reductions in the bacterial load on the skin following in vivo simulation of actual use. CTFA submitted data outlining proposed log reduction criteria in an August 2003 submission to FDA (¹ (Also see "Triclocarban 1.5% Category I Antimicrobial Status Sought By P&G" - HBW Insight, 1 Sep, 2003.), p. 6).

The submission reconfirmed proposals made by the trade group and the Soap and Detergent Association in petitions to the agency in 2001, which led the FDA to reopen the administrative record for the topical antimicrobial drug products monograph in 2003 (² 'The Rose Sheet' June 2, 2003, In Brief).

Industry argues the current log reduction criteria lack clinical validation and that studies in scientific literature suggest the criteria are unattainable.

"NDAC may also consider the development and future implementation of markedly different methods of product evaluation," FDA says, noting there remains a "need for a practical regulatory standard that can be applied to imminent decisions about product marketing," such as NDA approval and OTC monograph criteria.

Following presentations at the March 23 meeting, NDAC will be asked to provide input on additional topics, FDA notes, outlining in the briefing a number of issues for the advisory board to consider.

These include topics such as whether or not FDA should continue to review NDAs for healthcare antiseptics, and if so, what standards should be applied to ongoing reviews and what modifications should be made to the NDA standards for the future.

FDA currently regulates healthcare antiseptics under the new drug review when products contain active ingredients that have not been previously investigated or they are new types of products, the agency notes.

FDA regulates other healthcare antiseptics under the OTC drug review. The agency addressed the review of healthcare antiseptic drug products in an amendment to the tentative final monograph for OTC healthcare antiseptic drug products in 1994. The TFM for OTC Topical Antimicrobial Drug Products was published in 1978.

"DOTCDP is working to finalize this monograph in the near future and would like to have standards (i.e., test methods and efficacy criteria) for the OTC drug review that are consistent with the standards used in the NDA review," FDA explains.

Other areas FDA asks NDAC to consider focus on the TFM criteria, including the relationship between the use of health care antiseptics and current infection rates in the general population.

"If it can be assumed that OTC healthcare antiseptics help to lower infection rates, what would be the impact, if any, of changing the criteria on which products are evaluated?" the briefing document asks.

FDA further requests NDAC consider "what measures of product performance should be available in product labeling to accurately characterize individual products and to help users compare products." The agency also released evaluations of CTFA/SDA scientific literature reviews (see ³ (Also see "Industry Antiseptic Literature Review Does Not Support Benefit – FDA" - HBW Insight, 21 Mar, 2005.) ).