FDA approves first over-the-counter birth control pill

The Food and Drug Administration (FDA) on Thursday granted approval for Perrigo to sell the first over-the-counter birth control in the U.S., paving the way for more women to be able to access the contraceptive.

Starting in early 2024, Perrigo’s daily Opill medication will be sold without a prescription for women. It will be available at stores and online at leading retailers nationwide with no age restrictions on sales. 

Perrigo’s stock jumped on the news.  

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Although the pill won’t be shipped out until early next year, Perrigo CEO Patrick Lockwood-Taylor said Thursday’s news “marked a truly momentous day for women’s health.” 

The pill “has the potential to radically transform women’s access to contraception,” Lockwood-Taylor said. 

Hormone-based pills have long been the most common form of birth control in the U.S., used by tens of millions of women since the 1960s. Until now, all of them required a prescription. 

Nearly one-third of women in the U.S. who have tried to obtain a prescription or refill for a contraceptive pill, patch or ring reported difficulties doing so, Perrigo said, citing data from the National Library of Medicine. 

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Opill has only progestin, which prevents pregnancy by blocking sperm from reaching the cervix. It must be taken around the same time daily to be most effective.

In its internal review published in May, the FDA noted that some women in Perrigo’s study had trouble understanding the drug’s labeling information. In particular, the instructions warn that women with a history of breast cancer should not take the pill because it could spur tumor growth.

Common side effects include bleeding, headaches, dizziness and cramps, according to the FDA. The label also cautions that certain drugs can interfere with Opill’s effectiveness, including medications for seizures, HIV and hypertension.

Perrigo submitted years of research to the FDA to show that women could understand and follow instructions for using the pill. Thursday’s approval came despite some concerns by FDA scientists about the company’s results, including whether women with certain underlying medical conditions would understand they shouldn’t take the drug.

France-based HRA Pharma, which was acquired by Perrigo Co., first submitted an application last year to sell Opill as an over-the-counter medication. 

Perrigo did not announce a price Thursday. However, over-the-counter medicines are generally much cheaper than prescriptions, although they typically aren’t covered by insurance.

The Associated Press contributed to this report.