Outside advisers to the U.S. Food and Drug Administration (FDA) have voted unanimously to make the first birth control pill available over the counter without a prescription.
If the FDA follows this guidance, the drug, called Opill, would be the first oral contraceptive in the United States to become available without a prescription. Opill is being reviewed for use over-the-counter for all females of reproductive age, without any limitations on use by teenagers.
The FDA isn’t required to follow the recommendations of its independent advisory committees, but regulators generally do follow this guidance.
“Over-the-counter access to the pill will make it easier for people to physically and logistically access birth control in their communities,” says Dana Singiser, co-founder of the Contraceptive Access Initiative (CAI) and a board member of Planned Parenthood Metro Washington.
“The people who may benefit the most from the pill on the shelf are those in rural areas, people who can’t afford doctor visits and others,” Singiser adds.
Major Medical Organizations Support OTC Access to Opill
National medical groups including the American College of Obstetricians and Gynecologists, American College of Family Physicians, among many others, according to the CAI, have studied the evidence and endorsed OTC access.
The American Medical Association (AMA) praised the advisory committee vote. The AMA’s president, Jack Resneck Jr., MD, said that “access is one of the most cited reasons why patients do not use oral contraceptives.” The association, he said, “[urged] the FDA to act swiftly to approve over-the-counter access to oral contraceptives without an age restriction.”
Two separate advisory FDA advisory panels reviewed the evidence in support of moving Opill over the counter: the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee.
Opill More Effective Than Other OTC Forms of Contraception
One question raised by regulators that the advisory committees considered was whether women would be able to take birth control correctly without getting guidance from a doctor. To effectively prevent pregnancy, oral contraceptives need to be consistently taken at the same time each day.
Per the FDA, HRA Pharma — the company that makes Opill — presented data to the advisory committees noting that even when women get a prescription, about 15 percent of users miss three or more doses a month.
In addition, HRA Pharma pointed out that taking Opill over the counter would still be far more effective at preventing pregnancy than other options available without a prescription, such as condoms, spermicides, fertility-awareness apps, and using the withdrawal method.
With Opill, 4 to 7 percent of women will get pregnant a year, compared with 13 to 27 percent of women using other options available without a prescription, according to the HRA Pharma presentation to the advisory committees.
Opill Safe for Most Women
According to a past paper, pill was first approved by the FDA for use as a prescription oral contraceptive in 1973. The drug contains the hormone progestin.
“Progestin-only hormonal birth control pills are very safe and are only contraindicated for a small number of conditions, the main one being breast cancer,” says Kristyn Brandi, MD, a Darney-Landy Fellow with the American College of Obstetricians and Gynecologists, who practices in New Jersey.
“I trust my patients to read the back of the box at the pharmacy and know whether or not a medication is appropriate for them,” Brandi adds. “Patients can also still ask doctors or pharmacists for clarification on whether a drug might be contraindicated for them. We already trust patients every day to read and follow instructions on a wide range of over-the-counter medications — including ones that are less safe than hormonal birth control.”
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