OTC birth control arrives in the US

The first-ever over-the-counter contraceptive pill has finally been approved for sale in the US, extending the choice of birth control options available to women.

The progestin-only Opill (norgestrel) will be a “giant leap for women’s empowerment,” said its manufacturer, Perrigo subsidiary HRA Pharma, which has said it will launch the OTC version online and in retail stores early next year. OTC oral contraceptives are already available in more than 100 other countries worldwide.

Approval of the ‘mini-pill’ was backed by an FDA advisory committee in May, after a two-day meeting considered whether making it available without a doctor’s prescription could lead to inappropriate use and an increase in unintended pregnancies.

The FDA said studies showed that user understanding of the correct way to use the product was high, including the need to take it at the same time each day and to avoid certain other medicines that can interfere with its efficacy.

“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,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER).

The FDA estimates that around half of the 6.1 million pregnancies in the US every year are unplanned, and said access to an OTC pill may reduce that number.

Opill was first launched 50 years ago, so has a very long history of use. As a progestin-only pill, it does not contain oestrogen, reducing the risk of rare blood clot-related side effects that can occur with combination oral contraceptives.

The approval comes as birth control has emerged as a pivotal issue in the US, in light of the landmark ruling by the Supreme Court last year to strip US women of their constitutional protection for the right to abortion, ongoing battles over access to abortion pills, and efforts by emboldened anti-abortion groups to target hormonal birth control.

Last month, President Joe Biden signed an executive order asking government departments to look into ways in which access to affordable contraception could be strengthened, including through OTC options.

FDA approval is only one element of securing access to Opill, and the next step will be to make the product affordable. On that issue, Perrigo isn’t giving much away yet, but said during a press conference that it is “committed to ensuring that Opill is affordable and accessible to people who need it.”

The company also cited 2016 data showing that nearly a third of adult US women who had ever tried to obtain a prescription or refill for a contraceptive pill, patch, or ring reported difficulties doing so.

Barriers included financial concerns, lack of transportation to clinics, living in a rural area or underserved community with limited availability of clinics, and cultural and linguistic challenges. Other studies, meanwhile, have suggested the issue is more acute for black women and other women of colour.

The Opill approval has been praised by the American College of Obstetricians and Gynaecologists, which called it “a critically important advancement in the accessibility of reproductive health care.”