FDA approves first over-the-counter birth-control pill

By Eleanor Laise

Pill will be available at retail stores across the country early next year, but affordability and insurance coverage are still in question

The U.S. Food and Drug Administration on Thursday approved the first over-the-counter birth-control pill, clearing the way for consumers of all ages to be able to buy the pill without a prescription early next year.

The pill, called Opill, will be available at retail stores across the country and online early in the first quarter of 2024, the drug's manufacturer Perrigo Co. (PRGO) said in a release.

The FDA approval, coming just over a year after the U.S. Supreme Court overturned the constitutional right to obtain an abortion, broadens access to contraception at a critical moment, reproductive-health experts say. It's not yet clear, however, just how accessible the pill will be, in part because private health-insurance plans generally aren't required to cover FDA-approved contraceptives without a prescription.

"FDA approval is an important step forward, but we must ensure that over-the-counter birth control pills are equitably accessible to all, which means they're priced affordably and fully covered by insurance," Victoria Nichols, project director of Free the Pill, a coalition of more than 200 reproductive-health research, advocacy and provider groups, said in a statement Thursday.

Perrigo said that it will release pricing information in the coming months, ahead of the pill's availability in stores. The company is also working to get the pill covered by private insurers and Medicaid and is developing a patient-assistance program for people who might want to take the pill but are struggling to make ends meet, Frederique Welgryn, Perrigo's global vice president for women's health, said during a press briefing Thursday morning.

"We are committed to ensuring Opill is affordable and accessible to the people who need it," Welgryn said.

By removing the prescription requirement, the approval knocks down roadblocks that have prevented many people from using one of the more effective contraception methods. About one-third of U.S. adult women who have tried to obtain prescription contraception reported barriers to access, including challenges getting an appointment or finding transportation to a clinic, lack of insurance and other issues, according to a study by researchers at University of California San Francisco and Ibis Reproductive Health.

The over-the-counter pill will likely help reduce the number of unintended pregnancies, which account for nearly half of the 6.1 million U.S. pregnancies each year, according to the FDA. Birth-control pills are generally more effective than the contraception methods that are traditionally available over the counter. Risks associated with unintended pregnancies include a lower likelihood of receiving early prenatal care and a higher risk of preterm delivery, which can come with a range of negative neonatal and developmental outcomes.

With the approval, the U.S. joins more than 100 other countries where birth-control pills are already available without a prescription, according to Ibis Reproductive Health.

FDA advisers in May voted unanimously to recommend the agency approve Opill for use without a prescription, despite some safety issues raised by the FDA, such as whether women who currently have or previously had breast cancer would appropriately avoid using the pill. Perrigo has said that data from its eight-year development program show that consumers can use Opill safely and effectively as guided by the label. "The benefits of having access to Opill over the counter overwhelmingly outweigh the potential risks," Welgryn said during the press briefing.

Opill's active ingredient, norgestrel, was first approved for prescription use in the U.S. 50 years ago, and Pfizer marketed the pill as a prescription product for more than 30 years. French drugmaker HRA Pharma bought the rights to the pill in 2015 with the aim of getting over-the-counter approval. Perrigo bought HRA Pharma last year.

The pill's availability to people of all ages is critical, Dyvia Huitron, an organizer with sexual health and justice group Advocates for Youth, said during the press briefing Thursday. "When I was 15 years old, I was denied the ability to obtain birth control for the first time in my life," Huitron said. "Now, as a 19-year-old, I've struggled for years to access this very vital piece of care, which isn't uncommon among my peers."

Perrigo's stock was up 2.2% midday on Thursday and is down about 0.9% in the year to date, while the S&P 500 has gained 17%.

-Eleanor Laise

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07-13-23 1256ET

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