FDA Issues Six Deferral Decisions for Final Health Care Antiseptic OTC Drug Monograph Ingredients

As previously reported, on May 1, 2015, FDA issued a proposal to amend the 1994 Tentative Final Monograph (TFM) for the over-the counter (OTC) health care antiseptic drug products, including health care personnel hand washes, health care personnel hand rubs, surgical hand scrubs, surgical hand rubs, and patient preoperative skin preparations.  FDA proposed to classify all active ingredients as category III because of missing information on all ingredients. In light of scientific developments since 1994, FDA proposed to require additional safety data to support the safety of antiseptic active ingredients. FDA further proposed to require that all health care antiseptic active ingredients have in vitro data characterizing the ingredients’ antimicrobial properties and in vivo clinical simulation studies.  The proposed rule identified data gaps for 11 of the 28 active ingredients that had been considered in the rulemaking for health care antiseptics.

FDA acknowledged that the proposed rule was complex. Moreover, the Agency indicated that it would consider requests to defer further rulemaking for specific active ingredients to allow time for studies to address the data gaps.

True to its word, on January 19, 2017, FDA posted letters in the docket deferring rulemaking on a number of active ingredients, namely

• Povidone-Iodine
• Isopropyl Alcohol
• Benzalkonium Chloride
• Benzethonium Chloride
• Chloroxylenol
• Ethyl Alcohol

For each of these ingredients, FDA has agreed to defer rulemaking initially for one year, with the possibility of an extension/renewal. The deferrals are conditioned on the parties’ initiation of studies. If FDA determines that no studies have been commenced or that the studies are not productive, it will proceed to rulemaking after the initial deferral. Parties that have been granted the deferrals are required to submit “clear statements of [their] intent to conduct all necessary studies with proposed timelines, as described in [their] letter, and submit full study reports to the public docket.” Each letter specifies the studies that FDA requires for the active ingredient. Further, all letters provide a timeline for the parties (e.g., parties must acknowledge receipt of the letter and submit a statement of intent within 60 days of receipt of the letter; they must submit a study plan within six months of receipt of the letter, submit reports at a specific time etc., etc.).

No deferrals were granted for the other five active ingredients discussed in the proposed rule, hexylresorcinol, iodine tincture, iodine topical solution USP, triclosan, and tricarbon. Presumably, FDA will complete rule making for these ingredients in accordance with the timeline mandated by the consent decree (requiring publication of a final rule by January 15, 2018).