US regulator approves first over-the-counter birth control pill

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The US drug regulator has approved the first-ever birth control pill that can be purchased without a prescription, marking a significant development in a nationwide battle over reproductive rights.

The Food and Drug Administration on Thursday approved Opill, an oral contraceptive made by the Irish-American pharmaceutical group Perrigo, for non-prescription use. The pill will be available to purchase at pharmacies, convenience stores, grocery stores and online.

The decision is expected to improve access to contraceptives and has been welcomed by advocates of reproductive rights after many states moved to increase restrictions on abortion.

Patrizia Cavazzoni, director of the FDA’s drug evaluation and research centre, said the approval would make the pill “an available option for millions of people in the US”.

The move is a milestone in the fight for reproductive rights in the US, after the Supreme Court overturned Roe vs Wade last year, removing women’s constitutional right to abortion that had been in place since 1973.

The legality of the abortion pill mifepristone remains uncertain after the Supreme Court halted a ruling from a Texas federal judge to withdraw the FDA’s approval of the pill, which if upheld would restrict access to the drug even in states with abortion protections.

Democratic lawmakers had pressed the FDA to approve the over-the-counter drug but conservative religious groups have strongly opposed the measure.

The FDA’s Cavazzoni said: “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available non-prescription contraceptive methods in preventing unintended pregnancy.”

Opill must be taken at the same time every day, the FDA said, and should not be used by those with a current or past diagnosis of breast cancer. It should also not be used with other hormonal birth control products.

The pill contains progestin, a hormone that helps regulate the menstrual cycle and pregnancy. It has been safely and effectively used for decades for birth control.

Ireland-based Perrigo said the pill would be available in-store and online at leading retailers across the US from the first quarter of 2024.

Frederique Welgryn, Perrigo’s global vice-president for women’s health, said the approval was a “groundbreaking expansion for women’s health in the US, and a significant milestone towards addressing a key unmet need for contraceptive access”.

She said the company was committed to making the pill “accessible and affordable to women and people of all ages”.

Perrigo said 45 per cent of 6mn yearly pregnancies in the US are unintended, and that one-third of adult US women who have ever tried to obtain a prescription or refill for birth control products, including the pill, have faced difficulties in doing so.

“Removing the prescription requirement for Opill improves access to a contraceptive method that is effective and well tolerated for all ages,” the company said.