FDA Issues Another “Final” Rule on Antiseptics; Defers Action on Three Active Ingredients for Use in Consumer Antiseptic RubsApril 17, 2019
Last week FDA issued a final regulation regarding consumer antiseptic rubs. In 2016, FDA had proposed that 28 active ingredients, including triclosan, are not eligible for evaluation under the FDA’s OTC Drug Review for use in consumer antiseptic rubs. FDA requested but did not receive more data on those ingredients. Three other active ingredients, ethyl alcohol, benzalkonium chloride, and isopropyl alcohol remain under consideration. In the proposed rule (described here), FDA indicated that it needed more information to ensure that the ingredients are safe and effective; according to FDA, developing science and increased frequency of use have resulted in concerns about absorption and systemic exposure to the ingredients included in topical drug products, such as the consumer antiseptic rubs. Thus, FDA has requested additional data, including so called MUsT information. In the final rule, FDA reaffirms the need for these data on the three active ingredients that remain under consideration. Similar data are needed for the health care antiseptics. To the extent that there is overlap of studies needed for certain ingredients, the industry need not repeat the studies. For example, data generated from a MUsT study sufficient to support a healthcare antiseptic indication will also be sufficient to support a consumer antiseptic indication, because the maximal usage across consumer settings is lower than the maximal usage in a healthcare setting.
The rule declaring the 28 ingredients ineligible for use in consumer antiseptic rubs is effective April 12, 2020. Since only a small percentage of the consumer antiseptic rubs currently marketed in the United States contain any of the 28 active ingredients that have been determined ineligible, the impact of this final rule will be relatively minor.
In its press release, FDA mentions that this final rule completes its series of rulemakings for OTC antiseptics to determine whether they are safe and effective. Presumably the Agency referred to the series of rulemakings required under the consent decree with NRDC. However, as readers of this blog know, FDA is not yet done. The Agency deferred decisions on certain active ingredients for consumer antiseptic washes (benzalkonium chloride, benzethonium chloride, and chloroxylenol), health care antiseptics (benzalkonium chloride, benzethonium chloride, chloroxylenol, ethyl alcohol, isopropyl alcohol and povidone iodine), and, now, the consumer antiseptic rubs (ethyl alcohol, benzalkonium chloride and isopropyl alcohol). FDA has not set a specific deadline for final action on these ingredients but instead will address their status “either after completion and analysis of ongoing studies to address the safety and effectiveness data gaps . . . or at a later date, if these studies are not completed.” The deferral letters for each ingredient set forth initial deadlines for submission of a plan to address the outstanding data gaps. Moreover, because FDA has not concluded that an active ingredient is GRAS/GRAE for any of the categories of the antiseptic drug products, the Agency has not yet addressed labeling and finished product efficacy testing. Thus, once the safety studies have been done, assuming FDA finds at least one ingredient in a category GRAS/GRAE, further rulemaking will be needed. In addition, rulemaking for the first aid antiseptics is not yet complete and in December 2018, FDA took only the first step on the path to a monograph for antiseptics for food handlers. The timing of the remaining rulemaking is not subject to the consent decree.