FDA’s OTC Program Has Changed, But Antiseptic Sector Prepares For More Of The Same
The future of OTC antiseptic products – including antibacterial soaps and sanitizing hand rubs and wipes – came into serious question under FDA monograph actions taken in recent years. Stakeholders agree that Congress’s recently enacted CARES Act promises to transform OTC drug review, but the data requirements and uncertainty surrounding OTC germ-killing ingredients may be quickly reinstated.
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Notwithstanding issues with contract testing labs and a lull in US FDA communication, the American Cleaning Institute is optimistic about progress to support GRASE decision-making for OTC topical antiseptic products, including pilot maximal usage trial (MUsT) studies and proposed investigations to see if antimicrobial soap reduces MRSA transmission in US military barracks.
The American Cleaning Institute is preparing to submit a healthcare personnel hand wash study to the US FDA pending confidentiality discussions, along with results from a literature review on the topic of antimicrobial resistance. A progress report is due to the agency in October, which could stave off an administrative order under the reformed OTC drug review system.
The public health emergency has shown that the US needs more hand sanitizers on store shelves, not less, right?