FDA Proposes Rule on APIs in Healthcare Antiseptics

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 05-05-2015 13:17


The US Food and Drug Administration (FDA) has issued a proposed 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 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. The most common active ingredients in health care antiseptics marketed under the over-the-counter drug monograph include alcohol and iodines. These products are different from consumer antiseptics, such as antibacterial soaps and hand sanitizer 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 health care antiseptics in the over-the-counter drug monograph are generally recognized as safe and effective (GRASE) for their intended use to reduce bacteria that potentially can cause disease. The FDA’s request for more safety and effectiveness data for health care antiseptic active ingredients should not be taken to mean the FDA believes that these products are ineffective or unsafe, said the agency in a statement explaining the proposed rule.

Since the FDA began review of health care 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. Emerging science also suggests that for at least some healthcare antiseptic active ingredients, systemic exposure (full body exposure as shown by detection of antiseptic ingredients in the blood or urine) is higher than previously thought, and existing data raise potential concerns about the effects of repeated daily human exposure to some antiseptic active ingredients. The FDA is particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients in the health care setting and on the use of these products by certain populations, including pregnant and breastfeeding health care workers, for which topical absorption of the active ingredients may be important.

The proposed rule does not require any health care antiseptic products to be removed from the market at this time. Instead, it requires manufacturers who want to continue marketing healthcare antiseptic 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 finalized, ingredients for which adequate safety and effectiveness data have been provided would continue to be available.

The proposed rule 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. The FDA will then evaluate all the data and comments that were received in response to this proposal to make a final determination regarding GRASE status for each active ingredient. The FDA’s final determination will be published as a final rule (final monograph). The move is part of the FDA’s larger, ongoing review of monograph antiseptic active ingredients to ensure these ingredients are proven to be safe and effective. This proposed rule does not affect healthcare antiseptics approved under the New Drug Application process, consumer antiseptic products (consumer antibacterial soaps) or consumer hand sanitizers.

Source: FDA


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