FDA seeks flexible OTC review process

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The FDA is looking to change its 40-year-old over-the-counter (OTC) review process and is asking for public input. The regulatory agency announced in the Federal Register that a goal of its March discussion is to make the review process more adept at meeting public needs and keeping pace with scientific changes, as opposed to simply throwing more bodies at the lengthy process and hoping for increased speed.

Among the items on its maybe-list would be to make it easier for drugmakers to alter the final monograph when safety issues pop up. The process currently requires what the regulator describes as a lengthy rulemaking process that “is not well-adapted to address new safety issues with the speed and agility that are necessary to serve the public health.”

As an example, the FDA notes that when the agency enacted the 1970s OTC review rules, pediatric dosing was based on information that applied to adults, but science has since shown that pediatric dosing requires pediatric data, not adult extrapolation. The agency's OTC review proposal indicates that the new knowledge requires new rules, such as pediatric data. Similarly, the agency writes that creating an NDA deviation process would allow manufacturers to add additional dosing information to current approvals without having to go through an entire review process for a new dose.

Or, as the Wall Street Journal notes, “the FDA still allows a 500-milligram over-the-counter Tylenol pill...to be sold despite liver toxicity issues.” The Journal notes that the FDA says 325mg should be the maximum dose, but “the regulatory framework doesn't allow such changes to be made quickly.”

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