Before Asking FDA For Novel OTC Switch, Be Sure DFL Alone 'Can't Get There'
"You need to demonstrate to the best of your ability that you can't get there with just the Drug Facts label," says ONDP Director Theresa Michele during presentation on the FDA office' work over the past year at Consumer Healthcare Products Association's annual regulations and science conference.
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FDA proposes a novel pathway to permit OTC drugs to be marketed with additional controls to assure appropriate use, more than a decade after floating the idea. The pathway has a new name (“ACNU” not “NSURE”) and very different commercial dynamics.
Publication of "ACNU" proposed rule wasn’t reached in a straight line and featured coining another term with a more of a regulatory sound, “NSURE.” The proposed rule also detours on explaining where the agency wouldn’t steer OTC drug manufacturing and marketing.
The “Nonprescription Drug Product with an Additional Condition” for OTC use proposed rule would add to drug firms’ workloads for some OTC switches. Along with NDAs, sponsors would need to show a DFL isn’t sufficient to ensure a consumer can appropriately self-select and use a drug OTC and how an “additional condition” system would work.