A New OTC Switch Pathway In US At Last: Acronym Isn’t The Only Thing That’s Changed

08 Jul 2022

• By Michael McCaughan

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.

Over the counter drugs — The new OTC proposed rule enters a political and commercial world that is very different than when it was originally conceived. • Source: Shutterstock

A lot has changed since the US Food and Drug Administration first raised the idea of creating a special pathway to permit marketing of nonprescription drugs with some form of additional controls to help ensure consumers use the products are used safely and appropriately.

For one thing, the initiative has a new acronym.