First Over-the-Counter Birth Control Pill Coming Soon

The birth control pill is about to become over-the-counter in the United States. On Thursday, the Food and Drug Administration approved the daily tablet medication Opill for nonprescription use. The drug’s makers expect the OTC version to be available in stores by early 2024, though its price is still unknown at this time.

Opill has been an approved form of hormonal birth control for about 50 years. Its only active ingredient is norgestrel, a synthetic version of progestagen, a class of hormones that regulate fertility in women, among other roles. Norgestrel is also used in combination with other hormones to prevent pregnancy or to treat menopause symptoms.

Opill’s maker is HRM Pharma, a company within the U.S. and Irish-based Perrigo Company. In July 2022, HRM Pharma announced that it would seek FDA approval to convert Opill from a prescription treatment to OTC. To obtain this kind of switch, the company had to provide evidence that patients could use the drug safely and effectively without supervision from a medical professional—a standard the FDA now agrees Opill has met.

“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, director of the FDA’s Center for Drug Evaluation and Research, 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.”

Reproductive rights advocates and medical experts have long called for the pill to be sold over-the-counter, arguing it would expand safe access to contraception for women. This need has become even more pressing as of late, thanks to the recent Supreme Court decision in 2022 that struck down Roe v Wade, which now allows individual states to more harshly regulate abortion. Potential users have been clamoring for an OTC option as well; a recent survey from the KFF found that over three-quarters of reproductive-age women would be in favor of such a treatment if it was deemed safe and effective.

One pressing concern about an OTC pill has been pricing, though. Many insurance plans these days have made prescription birth control pills cost little to nothing—coverage that might not be provided for an OTC alternative.

The Perrigo Company has not yet released its expected pricing for its OTC Opill. But the company has stated that it would ensure that the drug will be affordable and that it will create a customer assistance program that would provide Opill at no cost to some. The current Biden administration has also signaled that it would take steps to expand access and limit out-of-pocket costs for contraceptives in general.

According to the company, Opill will be available in retail and online stores sometime during the first quarter of 2024.

The birth control pill is about to become over-the-counter in the United States. On Thursday, the Food and Drug Administration approved the daily tablet medication Opill for nonprescription use. The drug’s makers expect the OTC version to be available in stores by early 2024, though its price is still unknown at this time.

Opill has been an approved form of hormonal birth control for about 50 years. Its only active ingredient is norgestrel, a synthetic version of progestagen, a class of hormones that regulate fertility in women, among other roles. Norgestrel is also used in combination with other hormones to prevent pregnancy or to treat menopause symptoms.

Opill’s maker is HRM Pharma, a company within the U.S. and Irish-based Perrigo Company. In July 2022, HRM Pharma announced that it would seek FDA approval to convert Opill from a prescription treatment to OTC. To obtain this kind of switch, the company had to provide evidence that patients could use the drug safely and effectively without supervision from a medical professional—a standard the FDA now agrees Opill has met.

“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, director of the FDA’s Center for Drug Evaluation and Research, 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.”

Reproductive rights advocates and medical experts have long called for the pill to be sold over-the-counter, arguing it would expand safe access to contraception for women. This need has become even more pressing as of late, thanks to the recent Supreme Court decision in 2022 that struck down Roe v Wade, which now allows individual states to more harshly regulate abortion. Potential users have been clamoring for an OTC option as well; a recent survey from the KFF found that over three-quarters of reproductive-age women would be in favor of such a treatment if it was deemed safe and effective.

One pressing concern about an OTC pill has been pricing, though. Many insurance plans these days have made prescription birth control pills cost little to nothing—coverage that might not be provided for an OTC alternative.

The Perrigo Company has not yet released its expected pricing for its OTC Opill. But the company has stated that it would ensure that the drug will be affordable and that it will create a customer assistance program that would provide Opill at no cost to some. The current Biden administration has also signaled that it would take steps to expand access and limit out-of-pocket costs for contraceptives in general.

According to the company, Opill will be available in retail and online stores sometime during the first quarter of 2024.