FDA Approves First Over-The-Counter Birth Control Pill

FDA Approves First Over-The-Counter Birth Control Pill

Opill Daily Oral Contraceptive | Perrigo via Reuters

On July 13, the Federal Drug Administration approved the first birth control pill for over-the-counter sales, a significant milestone for accessible reproductive health equity, making it easier for people to access the contraceptive.

“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,” Dr. Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “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.”

Perrigo, Opill’s manufacturer, called the FDA action a “milestone” and a “giant leap for women’s empowerment ” in a statement. The company expects the pill to be available in stores in early 2024, with no age restriction on sales. Perrigo said it’s committed to ensuring Opill is affordable and accessible for its consumers.

It’s estimated nearly half of the 6 million pregnancies in the U.S. each year are unplanned, and low-income parents, women of color, and teenagers are more likely to experience significant barriers to accessing birth control prescriptions and care. These barriers can include cost, lack of insurance coverage, and lack of available options. As a result, these groups are more likely to experience unintended pregnancies, which can have serious consequences for their health, education, and economic well-being.

On average, birth control pills range from $30-$50 without insurance coverage, making it a high expense for those who are uninsured. While over-the-counter medicines are typically cheaper than prescriptions, they aren’t generally covered by insurance. Perrigo says Opill aims to provide an alternative for the estimated 15 million U.S. women currently using no birth control or poor birth control methods. However, the actual accessibility of Opill depends on its pricing, which Perrigo has yet to announce.

For optimal effectiveness, it is essential to take the pill at the same time daily. The FDA advises against using Opill if you have a history of breast cancer. Common side effects of Opill include headaches, irregular bleeding or menstrual cycles, dizziness, abdominal pain, and nausea.

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