WASHINGTON, DC – July 13, 2023 – On July 13th, the Food and Drug Administration (FDA) approved the medicine Opill as the U.S.’s first birth control pill to be sold over-the-counter. This means that the pill can be obtained without a prescription. It is expected to be available to consumers by early 2024. There are no age restrictions to purchase this medicine. Many medical organizations including the American Medical Association, the leading professional society for obstetricians and gynecologists, and the Society for Adolescent Health and Medicine, and numerous reproductive rights groups support selling Opill without a prescription. The FDA had assessed that Opill was safe, effective, and easy for women of all ages to use correctly. The United Kingdom and some countries in South America, Asia, and Africa allow nonprescription contraception pills.
Opill (generic name is norgestrel) is a contraceptive medicine that is taken once a day. It is one of many hormone-based birth control pills which are the most common form of birth control in the U.S. The French drugmaker, HRA Pharma, manufactures the medicine. It has been available by prescription in the U.S. for 50 years. Many health care providers feel that hormone-based birth control medicine is more effective than all other nonprescription choices in preventing unexpected pregnancies. Americans will be able to obtain Opill online and at pharmacies, grocery stores, and convenience stores.
Frederique Welgryn, HRA’s chief strategy officer, said “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.”
There should be fewer barriers to obtaining an oral contraception medicine. Women will be able to get the medicine without first seeing a health care provider. Studies have shown that teens, women of color, and low resource women are less likely to be able to access oral birth control by prescription. Changing from prescription to over-the-counter status should improve access to the medicine for these groups.
Increasing access to over-the-counter birth control pills, should reduce the number of unintended pregnancies and improve maternal and perinatal outcomes. Unplanned pregnancies are associated with delayed prenatal care, a higher rate of preterm delivery, and adverse maternal and perinatal outcomes. The FDA says that almost one-half of the yearly pregnancies in the U.S. are unexpected. A recent Kaiser Family Foundation study found that one-third of women who uses birth control pills missed a dose because they couldn’t get a timely appointment to get a prescription from a health care provider.
Kelly Blanchard, president of an advocacy group that helped form Free the Pill, a coalition of more than 200 organizations, said “Amid nationwide attacks on reproductive rights, we celebrate this victory for equity, evidence-based research, and reproductive freedom.”
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