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FDA grants approval to first over-the-counter birth control pill

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  • Staff Report 

The U.S. Food and Drug Administration (FDA) has granted approval for the first over-the-counter birth control pill, Opill (norgestrel). This action, long advocated by reproductive rights organizations and leading medical associations, will make the daily oral contraceptive readily available without a prescription at online and physical outlets such as drug stores and grocery stores. “Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” declared Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.

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Opill, produced by French company HRA Pharma and owned by Ireland’s Perrigo, has been available by prescription since 1973. The over-the-counter status application was submitted last summer. Frederique Welgryn, HRA’s chief strategy officer, stated, “For a product that has been available for the last 50 years, that has been used safely by millions of women, we thought it was time to make it more available.” Perrigo plans to spend the rest of the year preparing the pill and its packaging for national and online distribution, with no age restrictions on sales, by early next year.

This change in Opill’s status is expected to remove many barriers to access for oral contraceptives, as it eliminates the need for a prior visit to a health care provider. The move could notably help teens, girls, women of color, and low-income individuals who often face greater difficulties in obtaining prescriptions. The availability of over-the-counter birth control could also reduce the number of unintended pregnancies and associated adverse impacts, such as delayed prenatal care or preterm deliveries. Currently, nearly half of the 6.1 million annual pregnancies in the U.S. are unintended, according to the FDA.



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