By Berkeley Lovelace Jr. - NBC News
The Food and Drug Administration on Thursday approved the over-the-counter sale of the oral contraceptive Opill, making it the first over-the-counter hormonal birth control pill available in the United States.
The approval is a major victory for medical groups, including the American Medical Association and the American College of Obstetricians and Gynecologists, who have been pushing for an over-the-counter birth control pill for years. It also comes amid legal battles over women's reproductive rights and myriad restrictions on abortion access.
"This is a monumental decision," said Dr. Melissa Simon, a professor of clinical gynecology at Northwestern University. "Over-the-counter contraceptives are available in more than 100 countries, so we have lagged behind in offering safe and effective products like this oral contraceptive pill to people trying to avoid pregnancy."
The oral contraceptive OpillHRA Pharma
Opill, also known as a "minipill," contains a hormone, progestin, and is taken daily. The FDA first approved it by prescription in 1973.
The FDA has announced that it will approve the over-the-counter version for all users of reproductive age, including adolescents, a measure that is expected to remove barriers to access and reduce the risk of unwanted pregnancies.
According to the FDA, nearly half of the 6.1 million pregnancies that occur each year in the U.S. are unwanted.
"When used as directed, daily oral contraceptives are safe and are expected to be more effective than currently available over-the-counter contraceptive methods in preventing unintended pregnancies," Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said in a statement.
However, people who want to buy the drug in stores will have to wait a little longer. The maker of the Opill, Perrigo's HRA Pharma, said it doesn't expect it to be available until "early 2024."
HRA Pharma has not yet revealed how much the over-the-counter pill will cost. The price will have to be very low, experts say, because over-the-counter drugs aren't typically covered by insurance.
Abortion ban advances after sixth week gestation in Iowa
July 12, 202300:30
The FDA's decision comes two months after an outside advisory committee unanimously recommended that Opill be marketed over-the-counter.
At the time, FDA scientists had expressed concern about whether women with breast cancer or a history of breast cancer would know not to use the drug. But FDA committee members said they didn't expect that to be a problem because, they say, many women with breast cancer are aware that they shouldn't use hormonal birth control.
Another concern was side effects, such as vaginal bleeding, and whether users, especially adolescent girls, would know to seek help from a health professional.
Ultimately, the FDA committee agreed that most women could determine for themselves whether the drug was right for them.
FDA Expert Panel Votes in Favor of Over-the-Counter Sale of Opill Birth Control Pill
May 11, 202301:02
Over-the-counter birth control pills are already sold in more than 100 countries, according to Free the Pill, an advocacy group dedicated to education about birth control.
A 2022 survey by the KFF, formerly known as the Kaiser Family Foundation, found that more than three-quarters of women of reproductive age favored over-the-counter birth control pills. The main reason for supporting the shift from prescription to over-the-counter was convenience, according to the survey.