FDA Panel Votes In Favor Of Perrigo's Birth Control Pill For OTC Use

(RTTNews) - A U.S. Food and Drug Administration advisory panel voted in favor of Perrigo Company plc.'s (PRGO) Opill Daily Oral Contraceptive for over-the-counter or OTC use.

Opill consists of 0.075 mg norgestrel, which has been used to prevent pregnancy in millions of women in the U.S. since it was approved by the FDA in 1973. About 50 years of use and scientific evidence show that progestin-only pills such as Opill are effective at preventing pregnancy and are safe for most women to use, Perrigo said in a statement.

Perrigo said Wednesday that the FDA's Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee (ORUDAC) voted unanimously 17 to 0, with no abstentions, that the benefits of making Opill, a progestin-only daily oral contraceptive, available for over-the-counter (OTC) use outweighs the risks.

The joint committee's vote, while not binding, will be considered by the FDA when making its final decision regarding the potential approval of Opill for OTC use, which is expected later this year.

The company noted that the OTC oral contraception has support from major medical organizations including the American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians. If approved, Opill would be the first birth control pill available over-the-counter in the U.S.

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