Opill, an Over-the-Counter Birth Control Pill, Will Be Available Soon

Why It Matters

The medication, called Opill, which was approved for over-the-counter sale by the Food and Drug Administration last year, will be the most effective birth control method available without a prescription, research shows — more effective than condoms, spermicides and other nonprescription methods.

Reproductive health experts said that its availability could be especially useful for teenagers, young women, and others who have difficulty dealing with the time, costs or logistical hurdles involved in visiting a doctor to obtain a prescription.

Some experts said they thought it might be a particularly good option for teenagers, who might otherwise rely on condoms.

Lupe M. Rodriguez, the executive director of the National Latina Institute for Reproductive Justice, said in a statement Monday that “over-the-counter access to birth control will greatly reduce the barriers like transportation, cost, language, and documentation.”

Opill is not a new medication — it was approved for prescription use 50 years ago. Reproductive health experts and members of an F.D.A. advisory panel cited its long history of safety and efficacy. It is 93 percent effective at preventing pregnancy with typical use. Women with certain conditions — primarily breast cancer or undiagnosed vaginal bleeding — should not take Opill. But for most women, “the risk is very low, and almost nonexistent if they read and follow the labeling,” Karen Murry, the deputy director of the F.D.A.’s office of nonprescription drugs, said in a memo explaining the approval decision.

Since the Supreme Court overturned the national right to an abortion in 2022, 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.

The approval of Opill faced very little public opposition from conservative groups that are often critical of measures that increase access to abortion, emergency contraception and sex education. Opposition appeared to come primarily from some Catholic organizations and Students for Life Action.

In a survey in 2022 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.

The Details

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. Cadence Health, a company that makes a combination pill, is also in discussions with the F.D.A. about applying for over-the-counter status.

Perrigo said Monday that Opill can be preordered from some online retailers. A three-month pack of Opill will also be sold by retailers at a price of $49.99. The company’s Opill.com website will also sell the three-month pack, as well as a six-month supply that will cost $89.99.

In its announcement, Perrigo said the company would provide a “cost-assistance program” to “help qualified low-income, uninsured individuals obtain Opill at low or no cost.”

What Happens Next

Making the pill affordable to all women remains a goal for reproductive health advocates, many of whom said Monday that the cost would be out of reach for some populations.

“As a high school student in Texas who struggled to get on the pill under the current system, and faced social stigma while trying, I know firsthand how important it is to ensure young people can walk into a store and easily access the contraception they need,” Maia Lopez, 17, a member of the FreeThePill Youth Council at the nonprofit Advocates for Youth, said in a statement. “While today is a huge step forward, the price is still steep for many teenagers I know.”

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 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 between $11 and $20.

Three Democratic senators — Patty Murray of Washington, Mazie Hirono of Hawaii and Catherine Cortez Masto of Nevada — issued a statement on Monday urging passage of legislation to require insurers to cover over-the-counter birth control. They have also pressed the federal government to do something similar under an executive order to improve contraception access that President Biden signed last year.

“The work doesn’t stop here — more needs to be done to make sure every American can access and afford the pill over the counter,” the senators said.