FDA approves first over-the-counter birth control pill

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By Steve Schuster

[email protected]

On Thursday, the U.S. Food and Drug Administration (FDA) Thursday approved the first daily oral contraceptive approved for use in the U.S. without a prescription.

Opill (norgestrel) tablet has received official approval for nonprescription use to prevent pregnancy.

According to FDA officials, approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores, grocery stores, as well through online retailers.

The timeline for availability and price of this nonprescription product is determined by the manufacturer. Other approved formulations and dosages of other oral contraceptives will remain available by prescription only, FDA officials noted.

“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,” Cavazzoni added.

Nonprescription availability of Opill may reduce barriers to access by allowing individuals to obtain an oral contraceptive without the need to first see a health care provider, officials added.

According to the FDA, nearly half of the 6.1 million pregnancies in the U.S. each year are unintended. Unintended pregnancies have been linked to negative maternal and perinatal outcomes, including reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, with associated adverse neonatal, developmental and child health outcomes. Availability of nonprescription Opill may help reduce the number of unintended pregnancies and their potential negative impact, officials said.

The contraceptive efficacy of Norgestrel was established with the original approval for prescription use in 1973. HRA Pharma applied to switch Norgestrel from a prescription to an over-the-counter product. For approval of a product for use in the nonprescription setting, the FDA requires that the applicant demonstrate that the product can be used by consumers safely and effectively, relying only on the nonprescription drug labeling without any assistance from a health care professional. Studies showed that consumer understanding of information on the Opill Drug Facts label was high overall and that a high proportion of consumers understood the label instructions, supporting their ability to properly use the drug when it is available as an over-the-counter product. When properly used, Opill is safe and effective, FDA officials said.

For additional information about Opill, including uses, restrictions, complications, limitations, and side effects, please click here.

The FDA granted the approval to Laboratoire HRA Pharma, recently acquired by Perrigo Company plc.

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