Doctors and nurses hundreds of times a day may use over-the-counter (OTC) antiseptic before giving shots or doing surgery. But the FDA would like to know the long-term effects of using that stuff day in and day out.
The agency said Thursday that it's proposing to ask manufacturers of over-the-counter antiseptics for "scientific data to support the safety and effectiveness of certain active ingredients" used in the OTC products. The FDA wants companies to provide data from both human and animal studies on absorption rates, blood levels, toxicology and possible links to cancer and hormonal problems.
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| FDA's Janet Woodcock |
Janet Woodcock, the head of FDA CDER, was quick to point out that the FDA is making no judgments and said at the point, the agency recommends that healthcare workers continue to use the products. The agency also said the proposed rule is not for the kind of consumer antiseptics like antibacterial soaps and hand sanitizer rubs, but instead for the ones that usually are alcohol- and iodine-based that are used for hand washes and rubs, surgical hand scrubs and and patient preoperative skin preparations.
The American Cleaning Institute, which represents manufacturers, not surprisingly agreed that that its members' products should continue to be used. It said that while the FDA already has received a "a wealth of scientific data that details the safety and effectiveness of these critical antiseptic products," the industry will continue to work with the agency to answer its questions.
The FDA said a lot has changed in the 40 years that it has been evaluating these products. "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 agency is giving manufacturers of the products 180 days to respond to the draft rule. Given that some healthcare workers use these products as many as 100 times a day, Theresa Michele, director of CDER's Division of Nonprescription Drug Products, said it is important that the FDA ensure its evaluations of the APIs is "up-to-date and appropriately reflect current scientific knowledge and patterns" of healthcare professionals.
The agency said this is part of its bigger picture look at OTC products. The FDA has been talking for years about overhauling the over-the-counter (OTC) drug approval process and last year began taking steps it says will allow it to approve those products, and respond to safety concerns, faster. An estimated 100,000 OTC products are on the market, many of which have yet to make it through the laborious three-step "monograph" approval process set out in 1972. The agency in 2012 found that a Chinese company had sold wipes to hospitals that were contaminated with bacteria and earlier shut down a U.S. plant for similar issues.
- here's the FDA announcement
- here's the proposed rule
- here's the American Cleaning Institute statement