FDA rais­es con­cerns about la­bel com­pre­hen­sion for OTC birth con­trol pill ahead of ad­comm

Per­ri­go is seek­ing to turn its dai­ly con­tra­cep­tive pill, known as Opill, in­to an over-the-counter op­tion. But ahead of a two-day ad­comm this week, the FDA laid out its con­cerns in brief­ing doc­u­ments, point­ing to ef­fi­ca­cy ques­tions and that women might not prop­er­ly use the con­tra­cep­tive with­out a doc­tor’s guid­ance.

In doc­u­ments ahead of Tues­day and Wednes­day’s joint meet­ing of the Non­pre­scrip­tion Drugs Ad­vi­so­ry Com­mit­tee and the Ob­stet­rics, Re­pro­duc­tive and Uro­log­ic Drugs Ad­vi­so­ry Com­mit­tee, FDA staff not­ed that the norgestrel tablet orig­i­nal­ly won ap­proval for pre­scrip­tion use back in 1973.

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