FDA ad­comm votes unan­i­mous­ly in fa­vor of ben­e­fit-risk pro­file of over-the-counter con­tra­cep­tive Opill

An FDA ad­comm vot­ed unan­i­mous­ly that the ben­e­fits of mak­ing Opill, a prog­estin-on­ly dai­ly oral con­tra­cep­tive, avail­able over-the-counter out­weighs the risks.

All 17 mem­bers of the Non­pre­scrip­tion Drugs Ad­vi­so­ry Com­mit­tee and the Ob­stet­rics, Re­pro­duc­tive and Uro­log­ic Drugs Ad­vi­so­ry Com­mit­tee vot­ed in fa­vor, agree­ing that there were enough da­ta pro­vid­ed by drug­mak­er Per­ri­go to con­clude that con­sumers will be like­ly to use it prop­er­ly. The ad­comm was al­so in fa­vor of the pill’s even­tu­al ap­proval in or­der to im­prove ac­cess to women try­ing to pre­vent un­want­ed preg­nan­cies, al­though that was not part of the vote.

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