FDA approves first over-the-counter birth control pill
The Food and Drug Administration announced July 13 it approved the sale of a birth control pill without a prescription for the first time in the United States, a move that will increase the availability of oral contraception and impact ongoing debates about abortion policy.
In a statement, Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said the approval of Opill, a progestin-only pill, "marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States."
"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," Cavazzoni said.
Currently, a woman seeking to use birth control pills must do so with a doctor's prescription.
While some have called for expanded access to contraception in the wake of the U.S. Supreme Court's June 2022 decision in Dobbs v. Jackson Women's Health Organization, which overturned the high court's jurisprudence on abortion as a constitutional right, others have argued that proliferating contraception without medical supervision could lead to more unintended pregnancies.
Opill is expected to be available for retail sale in the U.S. in the first quarter of 2024, its maker, Perrigo, said in a statement.
The FDA said the most common side effects of Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps and bloating; and the drug should not be used by those who have or have ever had breast cancer.
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