In a nonbinding vote, the outside experts concluded that the benefits of granting over-the-counter status to a contraceptive called Opill outweigh the risks. But the FDA, which is expected to make a decision this summer, has expressed reservations.
The FDA’s outside experts expressed confidence, in a 17 to 0 vote, that consumers could take an oral contraceptive called Opill correctly. They said the benefits of over-the-counter status, such as increased access to contraception, outweighed the risks, including a lack of strict adherence to pill-taking that could result in unintended pregnancies.
In the end, the outside experts showed strong support for allowing the progestin-only Opill to be sold over the counter. Several said that whether a woman takes such a pill at the right time every day — users of Opill are urged to take the drug in the same three-hour window daily — did not depend on whether a consumer got the drug with or without a prescription.
The FDA’s decision on the proposed OTC Opill is expected this summer or early fall. The ruling would not affect other birth control pills, but an approval might encourage other companies to seek nonprescription status, some supporters say. The staffers also said the results were mixed on studies exploring whether women who had breast cancer or certain other medical conditions would understand they should not take the drug.
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