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WASHINGTON -- A daily oral contraceptive pill containing norgestrel can be sold without a prescription, .

It's the first over-the-counter (OTC) birth control pill to win the agency's OK. To be sold as Opill, it's made by the Perrigo unit Laboratoire HRA Pharma.

"Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online," the agency said in announcing the landmark decision.

Norgestrel already has a 50-year history as a contraceptive, having been first approved as a prescription product in 1973. The FDA said Laboratoire HRA Pharma met its requirement to show "that the product can be used by consumers safely and effectively, relying only on the nonprescription drug labeling without any assistance from a health care professional."

"Studies showed that consumer understanding of information on the Opill Drug Facts label was high overall and that a high proportion of consumers understood the label instructions, supporting their ability to properly use the drug when it is available as an over-the-counter product."

, state officials, and others had long lobbied the agency to allow OTC contraceptive sales, arguing that the products' and that women shouldn't need a doctor's approval. An FDA advisory committee voted unanimously in May to recommend approval.

As with prescription norgestrel products, the OTC version comes with a number of contraindications including current or previous breast cancer and simultaneous use with another hormonal contraceptive. Women may experience changes in vaginal bleeding.

Notably, the FDA stressed, Opill "is not for use as emergency contraception and does not prevent pregnancy after unprotected sex."

"Today's announcement of FDA approval of the OTC sale of progestin-only birth control is a critically important advancement in the accessibility of reproductive health care," said Verda J. Hicks, MD, president of the American College of Obstetricians and Gynecologists, and Christopher M. Zahn, MD, the group's interim chief executive officer, in a press release.

"Barriers to access are one reason for inconsistent use or lack of use of contraception ... This change will allow for more patients to easily begin and continue using birth control consistently," Hicks and Zahn wrote.

"Data support that progestin-only birth control is safe and carries no or minimal risk for adverse effects such as venous thromboembolism. We trust our patients to safely determine if hormonal contraception is right for them."

Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, also weighed in, calling the approval a "monumental step in providing broader access to safe and effective reproductive health care for millions of patients."

"While it is important patients maintain relationships with their physician to stay up to date on screenings, requiring an office visit to begin birth control is an unnecessary hurdle for patients who must take time off work, find childcare, and travel to appointments," Ehrenfeld .

Frédérique Welgryn, PharmD, Global Vice President for Women's Health for Perrigo, during a press call on Friday, said the company will share the manufacturer's suggested retail price "in the coming months ahead of in-store availability," which she said is currently slated for "early 2024."

Perrigo is working to get Opill listed with private insurers and Medicaid and also plans to introduce a patient assistance program, Welgryn said.

Under the Affordable Care Act, most private insurance plans are required to cover FDA-approved methods of contraception. But insurers can require a prescription in some cases, explained Victoria Nichols, MPH, project director for .

"Even as we celebrate today, we must ensure that over-the-counter birth control pills are equitably accessible to all," Nichols said, including people of color, who research shows face disproportionate barriers to obtaining birth control.

"This means that OTC birth control pills must be priced affordably and fully covered by insurance," she said, adding that Free the Pill will work with policymakers to help drive solutions to ensure coverage without a prescription across public and private plans.

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