(Reuters) -The U.S. Food and Drug Administration on Thursday approved the first over-the-counter contraceptive pill, paving the way for millions of women in the country to purchase birth control without prescription.
The daily contraceptive Opill, sold by Perrigo, was first approved for prescription use in 1973, and the over-the-counter approval allows people to obtain it without first seeing a healthcare provider.
Perrigo will share its pricing plan for the pill next week. It will be available in stores and online in the first quarter of next year.
“Today marks an important step in the drive toward meaningful access to essential healthcare for Americans,” Health and Human Services Secretary Xavier Becerra said in a statement.
The approval is expected to cut barriers of access to contraceptives such as the cost and time of seeing a healthcare provider, advocacy groups have said.
Opill, also known as a “minipill”, does not contain the hormone estrogen unlike other contraceptive drugs and uses progestin, a form of the progesterone hormone which plays a role in the menstrual cycle and pregnancy.
“Enabling women to access this one brand of minipill is a ministep in the right direction. The FDA should allow all women to access all forms of hormonal contraception over-the-counter,” said Dr. Jeffrey Singer, a senior fellow at libertarian think tank Cato Institute.
The most common side effects of the pill include irregular bleeding, headaches, dizziness, and the FDA advises it should not be taken by those who have or have had breast cancer. It should also not be taken with other hormonal birth controls.
Some groups such as the National Catholic Bioethics Center have opposed making Opill available over the counter, pointing to its safety concerns such as abnormal bleeding, ovarian cysts and depression.
A panel of the FDA’s advisers had in May voted unanimously in favor of Opill’s OTC sale, with advisers saying that more women were likely to be harmed by an unplanned or unwanted pregnancy than the drug’s side effects.
Perrigo gained the daily-use pill first through its $2.13 billion acquisition of Paris-based HRA Pharma in 2021.
Shares of the company were up 2% in morning trading.
(Reporting by Manas Mishra and Sriparna Roy in Bengaluru; Editing by Arun Koyyur)
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