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FDA proposes to require new safety and efficacy data for consumer antiseptic washes

By Riëtte van Laack – On December 17, FDA published a proposal to amend the 1994 tentative final monograph (“TFM”) for OTC topical antimicrobial drug products, which addressed antiseptic healthcare products.  The proposed rule concerns consumer antiseptic products intended for use with water, referred to as “consumer antiseptic washes.”  As detailed in the proposal, FDA […]

By Riëtte van Laack

On December 17, FDA published a proposal to amend the 1994 tentative final monograph (“TFM”) for OTC topical antimicrobial drug products, which addressed antiseptic healthcare products.  The proposed rule concerns consumer antiseptic products intended for use with water, referred to as “consumer antiseptic washes.” 

As detailed in the proposal, FDA believes that currently available data suggest that consumer antiseptic wash ingredients may not be as safe as previously thought and that they require new clinical studies that support their efficacy.  The new safety and efficacy data are due by June 16, 2014.  Unless the Agency receives evidence to the contrary, consumer antiseptic wash active ingredient will be non-monograph (i.e., unapproved new drugs and/or misbranded drugs).  The additional evidence must include safety data as well as clinical data that do not just support a reduction in bacteria but demonstrate a clinical benefit from the use of consumer antiseptic wash products compared to non-antiseptic soap and water.  FDA proposes that a final rule would become effective one year after publication.

FDA’s proposal is, at least partly, the result of a settlement with Natural Resources Defense Council (“NRDC”), which in 2010 sued FDA alleging that FDA violated the Administrative Procedure Act (“APA”) and the FDC Act by unreasonably delaying the issuance of monographs establishing conditions for use of certain products containing triclosan as the active ingredient.  In the NRDC case Consent Decree, FDA agreed, inter alia, to publish a TFM for consumer antiseptic hand wash products by December 16, 2013.  (The TFM was released for public inspection on that date, but published the following day.)  As we previously reported, although the Consent Decree literally applies only to triclosan OTC drug monograph proceedings, FDA did not limit the proposal to that active ingredient. 

The proposal amends the 1994 TFM.  At that time, FDA determined that only povidone/iodine met the requirements to support a classification as generally recognized as safe and effective (“GRASE”) for antiseptic wash products.  Various other ingredients were found to be GRAS but not deemed effective.  In light of comments received on the TFM, scientific developments since 1994, and changes in the use patterns of consumer antiseptic washes (which FDA asserts now are used on a daily basis), FDA has determined that additional safety and effectiveness data are necessary to support a determination that any of these products, including povidone/iodine, are GRASE. 

In 1994, FDA proposed that a log reduction standard (the “glove juice test”) be used to provide evidence of effectiveness.  However, in light of the increased safety concerns associated with antiseptics, including possibly endocrine disruption and antimicrobial resistance, the Agency now proposes to require demonstration of an actual clinical benefit compared to soap and water.  According to FDA, “[d]ata from these clinical outcome studies will help assure that any potential risk from consumer antiseptic wash products is balanced by a demonstrated clinical benefit.”

Safety data also are a key focus of the TFM.  Among other things, FDA proposes to require evaluation of the potential for chronic toxicity and effects on reproduction and development as part of the safety assessment.

The proposed rule is available for public comment for 180 days, with a concurrent one-year period for companies to submit new data and information, followed by a 60-day period for rebuttal comments.  Assuming that the Agency will meet the deadlines under the Consent Decree, a final monograph is scheduled for Sept. 15, 2016.

Hand sanitizers, wipes, and antibacterial products used in health care settings are not affected by the current proposal.  However, the Consent Decree requires that FDA review these products as well.  For example, the Agency must issue a TFM for Healthcare Antiseptic Products by April 30, 2015, and a TFM for Consumer Antiseptic Hand Rub Products by June 30, 2016.  Thus, we anticipate rulemaking for those categories of products as well.

Hyman, Phelps & McNamara's attorneys counsel and assist HPM clients in gaining government approvals for new products and in developing strategies to support successful marketing in accordance with the requirements of the law and the enforcement policies of FDA and other regulatory agencies.

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