FDA Approves First Ever OTC Birth Control Pill

The Food and Drug Administration (FDA) approved the birth control medication Opill to be sold over-the-counter on Thursday, the first drug of this type to become available without a prescription.

Manufactured by the Irish firm Perrigo, the hormonal daily birth control pill will be available on pharmacy shelves starting next year. There will be no age requirements for purchase. 

"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, director of the FDA's Center for Drug Evaluation and Research, said in a statement. "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 American College of Obstetricians and Gynecologists and the American Medical Association have both supported over-the-counter availability of birth control for several years.

It is unclear how much the pill will cost over-the-counter. The telemedicine platform GoodRx estimates that the average birth control user spends $268 on the medication each year. Over-the-counter drugs are generally cheaper, however expenses are paid out-of-pocket instead of through insurance.

Oral contraceptives have been available since the 1960s, however until now they were only accessible with a doctor’s prescription. 

The Centers for Disease Control and Prevention reports that 14% of American women between 15 and 49 are currently on birth control pills. One in ten women in the age group instead opt for a long-acting reversible contraceptive,  such as an intrauterine device, or IUD.

Demand for these medications has surged since the Supreme Court overturned Roe v. Wade last summer.

While the Dobbs v. Jackson Women’s Health Organization from the high court last year did not directly address birth control access in the United States, legal experts have long warned that contraceptives could lose their protections next.

In his concurring opinion to the Dobbs ruling last year, Justice Clarence Thomas wrote that the court ‘should reconsider’ protections on contraception access last year, fueling these concerns.

Women’s health advocates have pushed for birth control to become available over-the-counter for decades. The drug's availability via prescription has limited access to those who can afford to see a health care provider, and pay the expensive cost of a prescription on top of that.

This has left many low income and women of color with limited access to the medications.

The FDA says that half of the 6 million U.S. pregnancies each year are unintended, and hopes this approval will “reduce barriers” for some women to access the drugs.

The Dobbs decision also led to a surge in demand for the drugs used for a medication abortion, mifepristone and misoprostol. A recent report found demand for the drugs online have increased 85% since the court’s ruling last year.

However, access to mifepristone remains in limbo after a federal judge struck down its FDA approval in April. It remains available pending appeal.