On Thursday, the Food and Drug Administration approved the first nonprescription daily oral contraceptive, Opill. The move could make birth control more accessible to women in the U.S., the administration said in a statement.
The news: The FDA’s decision will allow Opill to be sold in grocery stores, pharmacies, convenience stores and online. For this specific contraceptive pill, women will not need to meet with a health professional, as was a requirement to obtain any contraceptives in the past, per the FDA.
- The FDA stated that Opill’s price and date of availability to consumers is up to the pill’s manufacturer, Perrigo, to decide. The company said that the pills can be expected on shelves in early 2024, per The Wall Street Journal.
- “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,” said Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, in a statement from the FDA. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”
The bigger picture: This announcement comes just over a year after the U.S. Supreme Court overturned Roe v. Wade, leaving abortion access in the hands of state governments.
- In May, a panel of scientific advisers to the FDA voted that the benefits of allowing birth control to be obtained without a prescription “vastly outweighed the risks,” according to The New York Times.
- According to the FDA, nearly half of the 6.1 million annual pregnancies in the U.S. are unplanned. The administration linked unplanned pregnancies to “negative maternal and perinatal outcomes, including reduced likelihood of receiving early prenatal care in increased preterm delivery, with associated adverse neonatal, developmental and child health outcomes.”
Why has birth control historically only been available by prescription? An FDA spokesperson stated that in order for any drug to be available over the counter, pharmaceutical companies must submit additional information in their FDA drug application, and perform studies to prove that the average individual understands the potential risks of the drug, and knows how to use it properly, Scientific American reported.
- Scientific American continued to say that pharmaceutical companies have only recently begun this process for contraceptive pills, stating that the process of switching from prescription to over the counter can be a long and complicated one.