The U.S. Food and Drug Administration has issued a proposed rule asking for scientific data supporting that active ingredients used in antiseptics used in healthcare are safe and effective.
The rule would require manufacturers who want to continue marketing these products under the over-the-counter drug monograph to provide the agency with additional data on the active ingredients' safety and effectiveness, including information on potential hormonal effects and development of antibacterial resistance.
The FDA is seeking the additional information based on new scientific information and concerns expressed by experts on an FDA advisory committee that ingredients in healthcare antiseptics can cause disease. However, "the FDA's request for more safety and effectiveness data for healthcare antiseptic active ingredients should not be taken to mean that the FDA believes that these products are ineffective or unsafe," a press release states.
"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, MD, director of the FDA's Center for Drug Evaluation and Research. "The FDA recommends that healthcare personnel continue to use these products consistent with infection control guidelines while additional data are gathered."
The agency is asking for more information now because, since the FDA started reviewing healthcare antiseptics in the 1970s, the use of the products has become more frequent and knowledge about the product has changed.
"Today's proposal seeks to ensure the FDA's evaluation 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," said Theresa Michele, MD, director of CDER's Division of Nonprescription Drug Products.
The proposed rule is available for public comment for 180 days. Concurrently, companies have one year to submit new data and information, followed by a 60-day rebuttal comment period.
Find a Q&A for healthcare professionals on the proposed rule here.