FDA Law Blog: Recent Plan B One Step approval may reignite simultaneous Rx-OTC debate

WASHINGTON — The Food and Drug Administration may soon find itself in another Plan-B-generated quandary — the complications around granting a three-year marketing exclusivity for a medicine that is both prescription-only and over-the-counter, according to an FDA Law Blog posted Sunday by Hyman, Phelps & McNamara

At issue is the granting of three-year marketing exclusivity on an OTC new drug application when approvals of abbreviated new drug applications for prescription-only versions of the same medicine have already been approved. 

"It is undisputed that, based on FDA’s representations regarding the need for additional data to support approving Plan B One Step for use without a prescription by younger age groups, [Plan B One Step manufacturer] Teva conducted actual use studies that included participation by sufficient numbers of 15 and 16 year olds," wrote Kurt Karst, author of the blog.

That additional research was critical in the FDA's approval of expanding OTC use to younger females, Karst noted. 

At question is whether or not the PLAN B One-Step NDA supplement approval "affects the approval status of generic versions of PLAN B One-Step approved under ANDAs," Karst wrote. "The NDA supplement approval seems to raise the thorny issue of simultaneous prescription and OTC marketing of the same drug," he noted. "We don’t have the answers to those questions, but resolution of whether there is a simultaneous prescription and OTC marketing issue in the first place, and then what to do about it if there is, might be an interesting side-show as the Second Circuit takes up Judge [Edward] Korman’s decision."

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