U.S. FDA Approves First Over-the-Counter Birth Control Pill

In a major shift for reproductive health care in the United States, women will soon be able to purchase birth control pills from retailers without needing a prescription.

Thursday, the U.S. Food and Drug Administration (FDA) gave final approval to the first oral contraceptive, Opill, to be sold over-the-counter, without the need for a doctor visit or prescription, removing a long-standing hurdle in obtaining birth control medication.

"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 Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research, in a statement Thursday. "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."

The news comes at a time when millions of reproductive-age women live in states where abortion is criminalized.

The FDA announcement will likely impact poor and uninsured women without the means to see a doctor, who will now be able to access one of the oldest forms of contraception.

What is Opill?

First approved by the FDA 50 years ago, in 1973, Opill was available by prescription only until now. This announcement means the 0.075 mg norgestrel tablets, which have safely prevented unwanted pregnancies for half a century, will soon be available OTC.

Opill is a progestin-only pill, meaning it doesn't have the estrogen commonly found in other oral contraceptives. When taken daily, as advised, Opill prevents most unwanted pregnancies.

The drug's manufacturer, Perrigo, celebrated the FDA's announcement Thursday.

"Today's approval is a groundbreaking expansion for women's health in the U.S. and a significant milestone towards addressing a key unmet need for contraceptive access," said Frederique Welgryn, Perrigo's global vice president for women's health, in a statement. "Perrigo is committed to making Opill, which is now the most effective method available OTC at preventing pregnancy, accessible and affordable to women and people of all ages."

According to the FDA, almost half of the 6.1 million pregnancies in the U.S. each year are unintended.

"Availability of nonprescription Opill may help reduce the number of unintended pregnancies and their potential negative impacts," the FDA said.

When will Opill be available OTC?

It is unclear exactly when and where the birth control pills will be sold. The FDA announcement left the distribution timeline and price up to Opill's manufacturer.

According to the manufacturer, Perrigo, Opill will be available in-store and online at retailers "early in the first quarter of 2024." 

Who should not take Opill?

While millions of women will be prime candidates for Opill, those with specific health conditions may want to refrain from taking the medication.

Women who have breast cancer or a history of breast cancer, according to the FDA, should not take Opill.

"Consumers who have any other form of cancer should ask a doctor before use," the FDA said. "Opill also should not be used together with another hormonal birth control product such as another oral contraceptive tablet, a vaginal ring, a contraceptive patch, a contraceptive implant, a contraceptive injection or an IUD (intrauterine device)."