FDA approves first over-the-counter birth control pill

The US Food and Drug Administration on Thursday approved the birth control pill Opill to be available over-the-counter — the first nonprescription birth control pill in the United States.

“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,” Dr. Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

“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.”

Opill is a “mini-pill” that uses only the hormone progestin.

Its manufacturer, Perrigo, called the FDA action a “milestone” and a “giant leap for women’s empowerment ” in a statement.

“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 global vice president for women’s health.

Opill is expected to be available over-the-counter in stores in early 2024.

At a news briefing on Thursday, Welgryn said Perrigo is “committed to ensuring that Opill is affordable and accessible to people who need it.”

The suggested retail price will be communicated in the coming months, she said.

Kelly Blanchard with Ibis Reproductive Health, a sexual and reproductive health research organization that has advocated for over-the-counter birth control pills, said at the briefing that it is crucial that insurance covers Opill.

“There’s more work to be done at the state and federal level to change the regulations to ensure that over-the-counter method can be covered without cost-sharing,” she said.

The FDA has faced pressure to allow Opill to go over-the-counter from lawmakers as well as health care providers.

Last month, President Joe Biden issued an executive order directing the Treasury, Labor, and Health and Human Services secretaries “to consider new actions to improve access to affordable over-the-counter contraception.”

“These actions could include convening pharmacies, employers, and insurers to discuss opportunities to expand access to affordable over-the-counter-contraception; identifying promising practices regarding the coverage of over-the-counter contraception at no cost to patients; and providing guidance to support seamless coverage of over-the-counter contraception,” a White House fact sheet about the order said.

In a statement Thursday, the FDA addressed its potential effect on unintended pregnancies.

“Nonprescription availability of Opill may reduce barriers to access by allowing individuals to obtain an oral contraceptive without the need to first see a health care provider. Almost half of the 6.1 million pregnancies in the U.S. each year are unintended," the FDA said in the statement.

"Unintended pregnancies have been linked to negative maternal and perinatal outcomes, including reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, with associated adverse neonatal, developmental and child health outcomes. Availability of nonprescription Opill may help reduce the number of unintended pregnancies and their potential negative impacts.”

A recent study showed that it has become harder for women to access reproductive health care services more broadly — such as routine screenings and birth control — in recent years.

About 45% of women experienced at least one barrier to reproductive health care services in 2021, up 10% from 2017. Nearly 19% reported at least three barriers in 2021, up from 16% in 2017.

At Thursday’s briefing, Ann Marie Benitez with the National Latina Institute for Reproductive Justice said this is a way for people to “take back their bodily autonomy” — particularly communities that face barriers to health care.

“This is just one more avenue in which people can access the care when they want it and how they want it,” she said.

A group of advisers to the FDA recommended in May that Opill be approved for over-the-counter use.

American College of Obstetricians and Gynecologists President Dr. Verda Hicks and CEO Dr. Christopher Zahn said in a statement Thursday that the pill is safe.

“There are very few contraindications for the use of progestin-only contraception. Data support that progestin-only birth control is safe and carries no or minimal risk for adverse effects such as venous thromboembolism,” they said.

“We trust our patients to safely determine if hormonal contraception is right for them.”

The pill needs to be taken at the same time every day in order to be effective.

The medication should not be taken by anyone who has, or previously had, breast cancer, the FDA says.

Some side effects commonly experienced while on Opill are “irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating,” according to the FDA.