Food and Drug Administration advisers will meet in May to discuss whether the agency should allow a birth control pill to be sold over the counter.
The pill, called Opill from French drugmaker HRA Pharma, is currently approved by the FDA to prevent pregnancy, but it is only available with a prescription.
If approved, Opill would be the first birth control pill available over the counter in the U.S.
Approximately 45% of all pregnancies in the U.S. are unintended, according to the Centers for Disease Control and Prevention.
The American Medical Association has called for allowing birth control pills to be sold over the counter, saying it could remove barriers and increase access to contraceptives.
Two FDA advisory committees — the Nonprescription Drugs Advisory Committee and the Reproductive and Urologic Drugs Advisory Committee — were initially scheduled to meet on Nov. 18, but the agency pushed back that date to “review additional information requested related to the Opill Rx-to-OTC switch,” according to the company.
Opill is a progestin-only medication, also referred to as a “mini-pill.” Progestin is a synthetic hormone that mimics the effects of progesterone in the body. Oral contraceptive pills usually consist of the hormones estrogen and/or progestin and are taken once a day.
The push for prescription to over the counter comes amid legal battles regarding women’s reproductive rights.
In June, the Supreme Court overturned the landmark Roe v. Wade ruling that guaranteed a constitutional right to abortion.
Additionally, a federal judge in Texas is expected to make a ruling on whether to issue a nationwide injunction on the drug mifepristone, one of two medications used in medication abortions.
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