Antiseptic TFM performance criteria too stringent, industry rep tells FDA advisory cmte.
This article was originally published in The Rose Sheet
Executive Summary
ANTISEPTIC TFM PERFORMANCE CRITERIA TOO STRINGENT, INDUSTRY REP CLAIMS at a meeting of FDA's Nonprescription Drugs Advisory Committee in Bethesda, Md. July 29. Rhonda Jones, Scientific & Regulatory Consultants, Inc., presented five examples of antiseptic formulations used in consumer and health care environments that she said "fall short of the current performance criteria proposed" in FDA's 1994 health care antiseptic tentative final monograph. Two triclosan hand wash formulations, 1% and .3% -- which are often found in consumer products -- do not meet TFM performance criteria, despite having "positive clinical outcomes" and the potential for "viral removal" in other studies, Jones maintained.