F.D.A. Approves First U.S. Over-the-Counter Birth Control Pill

The Food and Drug Administration on Thursday approved a birth control pill to be sold without a prescription for the first time in the United States, a milestone that could significantly expand access to contraception.

The medication, called Opill, will become the most effective birth control method available over the counter — more effective at preventing pregnancy than condoms, spermicides and other nonprescription methods. Experts in reproductive health said its availability could be especially useful for young women, teenagers and those who have difficulty dealing with the time, costs or logistical hurdles involved in visiting a doctor to obtain a prescription.

The pill’s manufacturer, Perrigo Company, based in Dublin, said Opill would most likely become available from stores and online retailers in the United States in early 2024.

The company did not say how much the medication would cost — a key question that will help determine how many people will use the pill — but Frédérique Welgryn, Perrigo’s global vice president for women’s health, said in a statement that the company was committed to making the pill “accessible and affordable to women and people of all ages.” Ms. Welgryn has also said the company would have a consumer assistance program to provide the pill at no cost to some women.

“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, director of the F.D.A.’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.”

Since the Supreme Court overturned the national right to an abortion last year, the accessibility of contraception has become an increasingly urgent issue. But long before that, the move to make a nonprescription pill available for all ages had received widespread support from specialists in reproductive and adolescent health and groups like the American Medical Association, the American College of Obstetricians and Gynecologists and the American Academy of Family Physicians.

In a survey last year by the health care research organization KFF, more than three-quarters of women of reproductive age said they favored an over-the-counter pill, primarily because of convenience. Nearly 40 percent said they would be likely to use it. Those most likely to opt for the product included women already taking birth control pills, women without health insurance and Hispanic women, the survey found.

And strikingly, at a time of fierce divisions over abortion, many anti-abortion groups have declined to criticize over-the-counter birth control. Opposition appears to come primarily from some Catholic organizations and Students for Life Action.

In May, a panel of 17 independent scientific advisers to the F.D.A. — including obstetrician-gynecologists, adolescent medicine specialists, a breast cancer specialist and experts in consumer health behavior and health literacy — voted unanimously that the benefits of making a birth control pill available without a prescription vastly outweighed the risks.

The panel cited the long history of safety and efficacy of Opill, which was approved for prescription use 50 years ago. The over-the-counter pill will be identical to the prescription version, which is 93 percent effective at preventing pregnancy with typical use.

Several panelists said there was a pressing public health need for an over-the-counter option in a country where nearly half of all pregnancies are unintended.

“The evidence demonstrates that the benefits clearly exceed the risks,” said one advisory committee member, Kathryn Curtis, a health scientist with the Centers for Disease Control and Prevention’s division of reproductive health.

She added: “I think Opill has the potential to have a huge positive public health impact.”

For proponents of over-the-counter pills, the main issue is affordability.

“If available equitably — meaning that they are priced affordably and fully covered by insurance — over-the-counter birth control pills will be a game-changer for communities impacted by systemic health inequities,” said Dr. Daniel Grossman, director of Advancing New Standards in Reproductive Health, who has led research on over-the-counter contraception.

The Affordable Care Act requires health insurance plans to pay for prescription contraception, but not over-the-counter methods. Some states have laws mandating coverage of over-the-counter birth control, but most states do not. The KFF survey found that 10 percent of women would not be able or willing to pay any out-of-pocket cost for contraception. About 40 percent would pay $10 or less per month, and about a third would pay $20 or less.

Under a recent executive order by President Biden, the federal government could soon take steps toward requiring insurers to cover over-the-counter birth control. And Senate Democrats have reintroduced legislation to require such coverage.

“We need to make it affordable and available,” Senator Patty Murray, a Democrat from Washington State and the lead sponsor of the bill, said in an interview in May. “Let’s provide women what they need and make sure it’s affordable so there’s equity, and women who are low-income, women who for whatever reason are struggling don’t have to be forced to not have any birth control simply because they can’t afford it today,” she added.

Opill is known as a “mini pill” because it contains only one hormone, progestin, in contrast to “combination” pills, which contain both progestin and estrogen. A company that makes a combination pill, Cadence Health, has also been in discussions with the F.D.A. about applying for over-the-counter status.

The F.D.A. analysts who evaluated the data Perrigo submitted in its application for a nonprescription Opill had raised concerns about whether women with medical conditions that should preclude them from taking birth control pills — primarily breast cancer and undiagnosed vaginal bleeding — would follow the warnings and avoid the product. The F.D.A. analysts also raised questions about whether younger adolescents and people with limited literacy could follow the directions.

But in a memo explaining the approval decision on Thursday, Karen Murry, deputy director of the F.D.A.’s office of nonprescription drugs, wrote, “For an individual consumer of the product, the risk is very low, and almost nonexistent if they read and follow the labeling.”

“Overall,” she continued, “the total public health impact of the potential harm related to incorrect use by people with progestin-sensitive cancer is likely outweighed by the probable larger public health impact of prevention of a large number of unintended pregnancies with all their attendant harms.”

Several advisory committee members said patients with breast cancer, the main medical condition that precludes taking hormonal contraception, typically have doctors who would advise them to avoid birth control pills. They also said that Opill might actually be safest for adolescents because they are very unlikely to have breast cancer. And because young people often start off with contraception they can buy over-the-counter, it is especially important for them to have easy access to a method more effective than condoms and other birth control products available in retail stores, the panelists said.

Perrigo reported that participants in a study took Opill on 92.5 percent of the days they were supposed to take it. Most participants who missed a pill reported that they had followed the label’s directions to take mitigating steps, such as abstaining from sex or using a condom, Dr. Stephanie Sober, the company’s U.S. medical liaison, said at the advisory committee hearing. She said that among 955 participants, only six became pregnant while using Opill.

Most people who said they had missed doses attributed that to running out of pills before they could get to one of the study’s resupply sites, results that, Dr. Sober said, “illustrate precisely the barriers to adherence that could be lessened” by making the pill available over the counter.

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