FDA rule to address data gaps for ingredients in healthcare antiseptics

Product use should continue in the healthcare setting while additional data are gathered

The US Food and Drug Administration (FDA) has proposed a rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in healthcare antiseptics marketed under the over-the-counter (OTC) drug monograph.

Healthcare antiseptics are primarily used by healthcare professionals in hospitals, clinics, doctors’ offices, outpatient settings and nursing homes. They include hand washes and rubs, surgical hand scrubs and rubs (with or without water), and patient preoperative skin preparations, including pre-injection preparations.

'Healthcare antiseptics are an important component of infection control strategies in hospitals, clinics and other healthcare settings, and remain a standard of care to prevent illness and the spread of infection,' said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER). She went on to say the FDA recommends that healthcare personnel continue to use these products consistent with infection control guidelines while additional data are gathered.

The most common active ingredients in healthcare antiseptics marketed under the OTC drug monograph include alcohol and iodines. These products are different from consumer antiseptics, such as antibacterial soaps and hand sanitiser rubs, which are not part of this proposed rule.

Based on new scientific information and concerns expressed by outside scientific and medical experts on an FDA advisory committee, the agency is requesting additional scientific data to demonstrate that these healthcare antiseptics are generally recognised as safe and effective (GRASE) for their intended use to reduce bacteria that potentially can cause disease.

Since the FDA began review of healthcare antiseptics in the 1970s, many things have changed, including the frequency of use of some of these products, hospital infection control practices, new technology that can detect low levels of antiseptics in the body, the FDA’s safety standards and the scientific knowledge about the impact of widespread antiseptic use.

The FDA is particularly interested in data on the long-term safety of daily, repeated exposure to these ingredients in the healthcare setting and in certain populations, including pregnant and breastfeeding healthcare workers.

'Today healthcare professionals use antiseptic products much more frequently than they used to, in some cases up to 100 times a day,' said Theresa Michele, director of CDER’s Division of Nonprescription Drug Products. The FDA's proposal seeks to ensure the FDA’s evaluations and determinations for all healthcare antiseptic active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and patterns of use by healthcare professionals.'

This action is part of the FDA’s larger, ongoing review of monograph antiseptic active ingredients. It requires manufacturers who want to continue marketing such products under the monograph to provide the FDA with additional data on the active ingredients’ safety and effectiveness, including data to evaluate absorption, potential hormonal effects and development of bacterial resistance. Once the proposed rule is finalised, ingredients for which adequate safety and effectiveness data have been provided would continue to be available.

The proposal will be available for public comment for 180 days. Concurrently, companies will have one year to submit new data and information, followed by a 60-day rebuttal comment period.