First Ever Over-the-Counter Birth Control Gets FDA Approval After Years of Hesitancy

The U.S. Food and Drug Administration (FDA) has approved a version of over-the-counter birth control that could pave the way for wider access to hormone-based contraception in the marketplace.


Irish pharmaceutical company Perrigo received approval to sell its version of the pill, Opill, without a prescription. OTC drugs are typically cheaper than prescription drugs, but they aren’t covered by insurance. Currently, there is no listed price for Opill.

“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, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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 FDA did warn of some side effects from this pill.

The most common side effects of Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating.

Opill should not be used by those who have or have ever had breast cancer. Consumers who have any other form of cancer should ask a doctor before use. Opill also should not be used together with another hormonal birth control product such as another oral contraceptive tablet, a vaginal ring, a contraceptive patch, a contraceptive implant, a contraceptive injection or an IUD (intra-uterine device).


Women’s health advocates have been pushing for greater access to birth control in the wake of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization at the end of the 2022 term. Those groups are celebrating today’s decision.

Medical societies and women’s health groups have pushed for wider access, noting that an estimated 45% of the 6 million annual pregnancies in the U.S. are unintended. Teens and girls, women of color and those with low incomes report greater hurdles in getting prescriptions and picking them up.

Some of the challenges can include paying for a doctor’s visit, getting time off from work and finding child care.

“This is really a transformation in access to contraceptive care,” said Kelly Blanchard, president of Ibis Reproductive Health, a non-profit group that supported the approval. “Hopefully this will help people overcome those barriers that exist now.”

Republicans were attacked in the wake of the Dobbs decision, with some progressives warning that Republicans might go after birth control next. However, Republicans have spent years pushing for greater access to OTC birth control as a way to combat abortion, as noted by commentator Glenn Reynolds in a USAToday column in 2019.

So why hasn’t it happened? It must be that awful, religious-right-dominated GOP that’s standing in the way, right?

Actually, not so much.

Republicans, in fact, have repeatedly tried to make birth control pills available without a prescription, only to face opposition from . . . Democrats and Planned Parenthood.


As Reynolds pointed out in his column, Planned Parenthood stands to possibly lose money with FDA approvals like this, as 27 percent of their $1.7 billion in revenue comes from contraception. “If women are buying their pills at CVS,” Reynolds noted, “there’s no insurance money rake-off for Planned Parenthood.”

But there have been a few Democrats for OTC access to birth control, like Alexandria Ocasio-Cortez.

According to Perrigo, Opill will be available in the marketplace in the first quarter of 2024. It will be available in pharmacies and for purchase online.


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