FDA Proposed Rule Puts Hospital Antiseptics Under Scrutiny

October 12th, 2016

WASHINGTON, DC – How many times a day do you use hand washes and rubs to prevent the spread of infections?

The answer is that you probably do it so often you lose count. You also aren’t likely to give much thought to how safe those products are. The Food and Drug Administration, however, is asking that very question.

The FDA recently 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 an important component of infection control strategies in hospitals, clinics and other health care 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 (CDER). “The FDA recommends that healthcare personnel continue to use these products consistent with infection control guidelines while additional data are gathered.”

So why was the action taken now?

Colleen Rogers, PhD, lead microbiologist in FDA’s Center for Drug Evaluation and Research’s Division of Nonprescription Drug Products, responds that “FDA’s safety standards and our ability to detect and measure antiseptics in the body have evolved since the active ingredients used in these products were last evaluated.”

Because many of these active ingredients have been used for a very long time, Rogers adds in an FDA blog, the available research often does not meet current scientific standards and also does not reflect the way the products are used today.

She said the latest effort is primarily to protect healthcare workers. “As you might imagine, a lot has changed in the practice of medicine since the early 1970s when our review of monograph antiseptics began. These days, antiseptics are being used more frequently – in some cases up to 100 times a day.”

That could result in greater systemic exposure to antiseptic active ingredients than previously thought, according to the FDA.

“In addition, new data and technology to detect these ingredients in body fluids – such as serum and urine – have become available and indicate that systemic exposure to antiseptic active ingredients could occur due to absorption through the skin,” Rogers notes.

The rule covers products marketed as reducing bacteria that can potentially cause disease; the most common active ingredients used in these products are alcohol and iodines. The active ingredients under FDA scrutiny must have been used in healthcare antiseptics that were on the market prior to 1972.

Chlorhexidine gluconate, also a common active ingredient in health care antiseptics, consumer antibacterial soup or consumer hand-sanitizers, is not affected by the proposed rule, however.

The FDA explained that over-the-counter drugs, including antiseptics, are regulated in one of two ways: under an OTC drug monograph or a New Drug Application. The data requests in the proposed rule pertain to OTC monograph health care antiseptics only and will not affect antiseptic products marketed under New Drug Applications.