FDA Approves First OTC Birth Control Pill in United States

The FDA has approved norgestrel (Opill) for OTC use to prevent pregnancy in all ages, making it the first birth control pill in the United States available without a prescription. The approval was granted to pharmaceutical company Laboratories HRA Pharma, which was recently acquired by Perrigo.

Norgestrel has been approved for prescription use since 1973, and HRA Pharma applied for OTC approval in July 2022. The FDA requires an applicant to demonstrate that a product can be used by consumers safely and that a drug label can be easily read without any assistance. The OTC approval was based on several label comprehension studies, as well as the ACCESS use trial, which showed consumers could use Opill correctly based on the label.¹

“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,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a release.² “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 OTC availability of norgestrel is expected to help reduce barriers to access by allowing people to obtain the medication without needing to see a health care provider. There are over 6 million pregnancies in the United States each year, nearly half of which are unintended. Unintended pregnancies have been associated with several negative outcomes, including increased risk of preterm delivery, and reduced likelihood of receiving early prenatal care.

Opill contains .075 mg of norgestrel and should be taken at the same time every day. Common side effects include cramps or bloating, irregular bleeding, abdominal pain, dizziness, nausea, headaches, and increased appetite. Those who have or have ever had breast cancer should not use norgestrel. Using medications that interact with norgestrel, including other hormonal birth control products, can result in decreased efficacy.

Norgestrel will be available in-store and online at leading drug, convenience, and grocery stores across the country beginning in the first quarter of 2024. Perrigo has not yet announced how much the medication will cost.

"Today's approval is a groundbreaking expansion for women's health in the US, and a significant milestone towards addressing a key unmet need for contraceptive access," Frederique Welgryn, Perrigo Global vice president for women's health, said in a release.³ "Perrigo is committed to making Opill, which is now the most effective method available OTC at preventing pregnancy, accessible and affordable to women and people of all ages.”

References

1. FDA Joint Advisory Committee Votes in Favor of Perrigo's Opill® Daily Oral Contraceptive for OTC Use. News Release. Perrigo. May 10, 2023. Accessed July 13, 2023. https://investor.perrigo.com/2023-05-10-FDA-Joint-Advisory-Committee-Votes-in-Favor-of-Perrigos-Opill-R-Daily-Oral-Contraceptive-for-OTC-Use

2. FDA Approves First Nonprescription Daily Oral Contraceptive. News Release. FDA. July 13, 2023. Accessed July 23, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive

3. Perrigo Announces U.S. FDA Approval for Opill® OTC Daily Oral Contraceptive. News Release. Perrigo. July 13, 2023. Accessed July 13, 2023. https://investor.perrigo.com/2023-07-13-Perrigo-Announces-U-S-FDA-Approval-for-Opill-R-OTC-Daily-Oral-Contraceptive