FDA advisory panel recommends nonprescription, over-the-counter birth control pill

A U.S. Food and Drug Administration advisory panel on Wednesday recommended that a particular birth control pill be sold over the counter.

The benefits of allowing for the OTC sale of Opill outweigh the risks, the panel said after discussing it at a joint meeting between the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee.

If approved by the FDA, Opill — which has been on the market for decades — would become the first-ever contraceptive medication sold without a prescription in the U.S. The panel members voted unanimously in favor of the request by drugmaker Perrigo, after meeting for two days to gauge whether women could use the pill safely and effectively without professional medical supervision.

The panel’s recommendation enables the FDA to make its final decision, which it will do this summer. Perrigo said OTC sales could begin as soon as late this year if approved, but would apply only to this particular incarnation of the birth control pill.

Regulators raised concerns about whether women who should not use oral contraception, such as those with breast cancer, would know not to take it. Others worried some women wouldn’t adhere to the package directions stipulating it be taken within the same three-hour window each day.

But FDA advisory board members said those issues could crop up with prescription birth control pills too. And in the case of breast cancer, a woman would presumably be under a doctor’s care anyway, so would have the necessary medical advice.

“I would think any woman who had a breast cancer diagnosis in the past would be highly aware of that, so I don’t think that’s going to be a concern,” said Dr. Deborah Armstrong of Johns Hopkins University.

More than 25 speakers supported the drugmaker’s application in public comments on Tuesday, while Catholic groups such as the United States Conference of Catholic Bishops opposed making it as easily available as aspirin, saying that a woman should first be required to consult with a doctor.

With News Wire Services