FDA Approves First Daily, Over-the-Counter Birth Control Pill

American women could soon buy daily birth control pills over the counter without needing a prescription from a doctor.

The Food and Drug Administration approved HRA Pharma’s Opill, a progestin-only oral contraceptive, on July 13. The regulatory agency said the decision “provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online.”

The agency did not say when the medication will be sold in stores nor how much it will cost. The manufacturer will determine both variables.

“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” said Mr. Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, in a press release. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”

According to the FDA, the Opill could reduce the number of annual unintended pregnancies in the US – roughly half of the 6.1 million pregnancies in the US each are unintended.

The agency listed the common side effects of Opill as bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating. Consumers who have or have previously had breast cancer are warned not to use the OTC pill. 

Progestin-only birth control pill “works by thickening cervical mucus and disrupting ovarian activity,” noted Politico.

An FDA advisory committee unanimously approved Opill in May. 

The American College of Obstetricians and Gynecologists has strongly advocated over-the-counter birth control pills. 

Kristyn Brandi, a gynecologist representing the ACOG who participated on the advisory committee, told Nature that the “scientific evidence is clear that over-the-counter access to contraception without age restrictions can be accomplished safely, and the benefit of increased access is significant.”

“People from marginalized communities, including racial and ethnic minorities, uninsured people and those who don’t speak English, are more likely to face these barriers,” said Brandi.

Some critics of Opill have argued the pill already carried serious health and safety concerns while also raising questions about the realistic results of making oral contraceptives available without doctor consultation.

A coalition of Catholic organizations – including the United States Conference of Catholic Bishops, the National Catholic Bioethics Center, the Catholic Medical Association, and the National Association of Catholic Nurses – urged the FDA not to approve Opill.

“We strenuously oppose the non-prescription availability of OPILL because such access to OPILL violates this inviolable standard of care,” wrote the group in a letter in November. “Any patient having access to a medication that has the documented and potentially [life-threatening] side effects that can be present with OPILL, at a minimum, should be medically evaluated for contraindications to the drug.”

The group listed a more expansive list of symptoms than the FDA, noting taking the pill comes with can increase a consumer’s risk of “side effects that clearly include indicators of organ failure, e.g., liver, cardiovascular, hemopoietic, or neurological systems: difficulty breathing, swelling of the ankles or feet, severe stomach or pelvic pain, unusual tiredness, dark urine, yellowing of the eyes or skin (jaundice), sudden shortness of breath, chest, jaw, and left arm pain, confusion, coughing up blood, sudden dizziness, fainting, pain, swelling, or warmth in the groin or calf, tingling, weakness, or numbness in the arms or legs, headaches with or without vision changes, lack of coordination, existing migraines becoming worse, sudden or very severe headache, trouble speaking, weakness on one side of the body, and vision problems.”

The group also argued that the failure rate of Opill “is higher than that of other hormonal contraceptive methods and will result in many unintended pregnancies, leading to potentially more abortions.”

“The failure rate of the minipill is higher than that of other hormonal contraceptive methods and will result in many unintended pregnancies, leading to potentially more abortions,” wrote the groups. 

Oral birth control has been linked to increased rates of depression, breast cancer, and cervical cancer.