The oral contraceptive Opill became the first hormonal contraceptive pill to be sold over-the-counter in the United States on Thursday after receiving approval from the Food and Drug Administration.
The clearance is a significant victory for medical organizations that have long advocated for an over-the-counter (OTC) birth control pill, such as the American Medical Association and the American College of Obstetricians and Gynecologists.
Additionally, it takes place as legal disputes over women’s reproductive rights continue.
Dr. Melissa Simon, a professor of clinical gynecology at Northwestern University, said, “This is a tremendous decision. We’ve lagged behind in providing safe, effective options like this oral contraceptive pill to people who are attempting to avoid pregnancy because OTC birth control is available in over 100 nations.
One hormone, progestin, is present in Opill, sometimes referred to as the “mini-pill,” which is taken every day. In 1973, the FDA granted it its initial prescription approval.
In order to remove access obstacles and lower the risk of unwanted pregnancies, the FDA said that it is approving the over-the-counter version for all users of reproductive age, including teens.
According to the FDA, nearly half of the 6.1 million pregnancies that occur in the United States annually are unplanned.
“When used as directed, daily oral contraception is safe and expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
Similar to prescription oral contraceptives, Opill was found to be 93% effective in preventing conception with normal use. Opill must be taken every day at the same time.
For the following two days, doctors advise using a backup technique like a condom if it isn’t taken within a three-hour timeframe.
According to the FDA, the drug should be accessible through pharmacies, gas stations, grocery shops, and online.However, it will take a little longer for people who choose to purchase the medication off of store shelves.
The Opill’s manufacturer, Perrigo’s HRA Pharma, stated that it won’t be accessible until “early 2024.”
The cost of the over-the-counter medication has not yet been published by HRA Pharma. Due to the fact that over-the-counter treatments are sometimes not covered by insurance, experts suggest the cost will need to be reasonable.
About two months after a third-party advisory council unanimously recommended making Opill available without a prescription, the FDA took action.
A concern raised at the time by FDA experts was whether women with breast cancer or a history of breast cancer would be aware not to use the medication.
However, the FDA committee members claimed they did not anticipate it to be an issue because they claimed many breast cancer patients are aware they shouldn’t use hormonal contraceptives.
current information on birth control pills
Another worry was whether users, especially teens, would be aware to seek medical attention if they had side effects like vaginal bleeding.
However, the FDA committee ultimately decided that the majority of women could decide for themselves if the medicine was right for them.
Dr. Sarah Prager, an expert in obstetrics and gynecology in Seattle, said that there are “no good scientific reasons” to prevent them from being as accessible as feasible.
Free the Pill, a group that advocates for birth control education, claims that over-the-counter birth control tablets are currently available in more than 100 other nations.
In a survey conducted in 2022 by KFF, formerly known as the Kaiser Family Foundation, it was discovered that more over 75% of women of reproductive age supported making birth control pills available over-the-counter.
According to the survey, convenience was the main factor encouraging people to switch from prescription to over-the-counter medications.
