The Food and Drug Administration on Thursday approved the over-the-counter oral contraceptive pill, making it the first hormonal birth control pill available in the US without a prescription.
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 (OTC) birth control pill for years. It also comes amid legal battles over women’s reproductive rights.
«This is a monumental decision,» said Dr. Melissa Simon, a professor of clinical gynecology at Northwestern University. «Over-the-counter birth control is available in more than 100 countries, so we’ve been behind in the availability of safe and effective methods, like this oral contraceptive pill, for people trying to avoid pregnancy.»
Opill, also known as the «mini-pill», contains a hormone, progestin, and is taken daily. came first approved by the FDA as a prescription in 1973.
The FDA said it is approving the over-the-counter version for all users of reproductive age, including teens., a measure that is expected to remove barriers to access and reduce the risk of unwanted pregnancies.
Nearly half of the 6.1 million pregnancies in the US each year are unintended, according to the FDA.
«When used as directed, daily oral contraception is safe and expected to be more effective than currently available non-prescription methods of contraception in preventing unintended pregnancy,» Dr. Patrizia Cavazzoni, director of the Center for FDA Drug Evaluation and Research. .
Opill was found to be 93% effective in preventing pregnancy with typical use, similar to prescription oral contraceptives. Opill should be taken at the same time every day. If it’s not taken within a three-hour period, experts recommend a backup method, such as a condom, for the next two days.
The drug is expected to be available in pharmacies, convenience stores, supermarkets and online, according to the FDA. However, people who want to grab the drug off store shelves will have to wait a bit longer. Opill’s maker, Perrigo’s HRA Pharma, said it doesn’t expect it to be available until «early 2024.»
HRA Pharma has yet to reveal how much the over-the-counter pill will cost. The price should be low, experts say, because over-the-counter drugs are generally not covered by insurance.
The FDA’s move comes about two months after an outside advisory committee voted unanimously to recommend making Opill available without a prescription.
At the time, FDA scientists had raised concerns 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 said many women with breast cancer know not to use hormonal birth control.
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Another concern was side effects, such as vaginal bleeding, and whether users, particularly adolescents, would know how to seek help from a health care provider.
Still, ultimately, the FDA committee agreed that most women could determine for themselves whether the drug was appropriate for their use.
Over-the-counter birth control pills are already in more than 100 countries, according to release the pillan advocacy group dedicated to educating about birth control.
TO survey 2022 of KFF, formerly known as the Kaiser Family Foundation, found that more than three-quarters of women of reproductive age favored making birth control pills available without a prescription. According to the survey, the top reason for supporting the switch from prescription to over-the-counter drugs was convenience.