Dive Brief:
- On Friday, the Food and Drug Administration issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in healthcare antiseptics.
- The antiseptics in question are currently being used in hospitals, nursing homes, physician offices and other outpatient settings.
- The FDA will be looking at things like topical absorption, possible hormonal changes, bacterial resistance, and potential effects related to pregnancy or breast-feeding.
Dive Insight:
The proposed rule does not require any healthcare antiseptic products to be removed from the market at this time. Instead, it requires manufacturers who want to continue marketing healthcare antiseptic products to provide the FDA with additional data on the active ingredients' safety and effectiveness. "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."