Unreasonable FDA restrictions could jeopardize safety


Unreasonable FDA restrictions on healthcare use of safe and effective antibacterial ingredients could jeopardize the safety of patients and healthcare workers alike, according to experts in the field.

In a presentation to FDA's Nonprescription Drugs Advisory Committee (NDAC), organized by the American Cleaning Institute (ACI), health professionals and industry safety experts said that active ingredients used in antibacterial hygiene products "clearly save lives" and are recognized as the "standard of care" for reducing healthcare infections.

"A robust body of research supports the safety of active ingredients used in healthcare antiseptic products," wrote ACI in comments submitted to the NDAC panel. "Any suggestion that the benefit or risk of these products is in question, especially by FDA, could lead to unintended adverse consequences if usage patterns were to change in the healthcare setting."

FDA is expected to propose a new set of rules governing antibacterial healthcare hygiene products in 2015.

"Healthcare providers need to have a full range of antibacterial actives at their disposal to best meet their infection control needs," said Dr Paul DeLeo, ACI associate vice president, environmental safety. "Any effort by FDA that would impede availability of these important ingredients would put patients and healthcare personnel at risk."

Speakers at the ACI-organized presentation urged the Advisory Committee to recommend that the FDA conduct a full risk assessment of currently available health and safety data on antibacterial ingredients.

"The active ingredients used in healthcare antiseptic drug products have a very favorable benefit/risk ratio demonstrated over many years of extensive use," said DeLeo. "These products clearly save lives by reducing bacterial transmission, which can cause infections in healthcare settings. By reducing healthcare-associated infections, these products also reduce healthcare costs."

FDA, FDA NDAC, American Cleaning Institute, US