November 16, 2015
The FDA recently presented the proposed regulation, Amendment of the Tentative Final Monograph, on May 1, 2015, which is to amend the 1994 tentative final monograph or proposed rule, the 1994 TFM, for over-the-counter antiseptic drug products. The FDA began soliciting comment letters and received statements from a number of companies during the past five months. On October 26, 2015, PDI submitted a comment letter expressing that the FDA should strongly consider the impact of the proposed amendments to the availability of antiseptic products to properly provide clinical care to the patients that they are used daily in the clinical setting and provided additional data to the FDA supporting the continued use of these products based on their long history of safety and efficacy in clinical practice.
Our decision to provide information in the form of a comment during the review period is part of our ongoing commitment to ongoing enhancement of safety and efficacy data for all healthcare antiseptics and also alcohol based hand rubs. It is also our belief that we can and should be a part of the process and be supportive and helpful in providing information to inform decision-makers as they deliberate and refine potential regulation/legislation.