The Food and Drug Administration (FDA) has granted approval for the sale of Opill, an oral contraceptive, without a prescription, making it the first hormonal birth control pill to be available over-the-counter in the United States.
This decision is a significant victory for medical organizations, including the American Medical Association and the American College of Obstetricians and Gynecologists, which have long advocated for over-the-counter access to birth control pills. It also comes at a time when reproductive rights are under legal scrutiny.
Dr. Melissa Simon, a clinical gynecology professor at Northwestern University, hailed the FDA’s approval as a monumental decision. She emphasized that over-the-counter birth control pills have been accessible in over 100 countries, and it is high time the U.S. catches up in providing safe and effective oral contraceptives to those who wish to prevent pregnancy.
Opill, often referred to as the “mini-pill,” contains a single hormone called progestin and is taken daily. It was initially approved by the FDA as a prescription medication in 1973. The FDA’s approval applies to all individuals of reproductive age, including teenagers, with the aim of removing barriers to access and reducing unintended pregnancies. According to the FDA, nearly half of the 6.1 million pregnancies in the U.S. each year are unintended.
Dr. Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, stated that 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 pregnancies.
However, the general public will have to wait a bit longer before being able to purchase Opill over the counter. Perrigo’s HRA Pharma, the manufacturer of Opill, anticipates its availability in early 2024.
The cost of the over-the-counter pill from HRA Pharma has not yet been disclosed. Experts believe the price should be kept low since over-the-counter medications are typically not covered by insurance.
The FDA’s decision follows the unanimous recommendation of an external advisory committee made approximately two months ago. Although concerns were raised regarding the use of the drug by women with breast cancer or a history of breast cancer, the committee members were confident that most women are already aware that hormonal contraceptives should not be used in such cases. Another concern was the possibility of side effects, like bleeding of the vagina, and whether users, particularly teenagers, would know when to seek medical assistance. Nevertheless, the committee agreed that most women can make an informed decision about using the medication.
Free the Pill, an advocacy group focused on birth control education, reports that over-the-counter birth control pills are already available in more than 100 countries.
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A survey conducted by KFF (formerly known as the Kaiser Family Foundation) in 2022 revealed that over three-quarters of women of reproductive age support the availability of birth control pills without a prescription. The primary reason for supporting the switch to over-the-counter availability was convenience, according to the survey.
