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Over-The-Counter Birth Control Pill Seeks FDA Approval In The US

The application comes in the wake of Roe v Wade being overturned, one of the biggest blows to abortion rights in US history.


Tom Hale

Tom is a writer in London with a Master's degree in Journalism whose editorial work covers anything from health and the environment to technology and archaeology.

Senior Journalist

A women takes a birth control contraceptive pill.
Over 1 in 3 women have said they'd want to use an over-the-counter birth control pill. Image credit: NUM LPPHOTO/

An over-the-counter birth control pill could soon be available on shop shelves in the US if it gets the thumbs up from the Food and Drug Administration (FDA). The Perrigo company has submitted its application to FDA asking for approval to sell the first-ever over-the-counter birth control pill available in the country. 

Known as Opill, the drug is a daily birth control pill (also known as a mini pill or non-estrogen pill) that contains only progestin, a form of the progesterone hormone that plays a role in the menstrual cycle and pregnancy. It works by thickening mucus in the cervix, preventing sperm from reaching the egg.


The pill has been approved as a prescription drug in the US since 1973, but the makers want to switch their license to sell it as an over-the-counter drug without the need for a doctor’s sign-off. 

Over-the-counter birth control pills are currently available in many parts of the world, including many countries in Asia, Latin America, and Africa, according to the advocacy group Free the Pill. However, they are currently only available by prescription in North America, Australia, New Zealand, and much of Europe.

The prospect of an over-the-counter birth control pill is supported by the American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians

Furthermore, over 1 in 3 women said they'd want to use this type of treatment. Around 29 percent of women of childbearing age report a problem obtaining a birth control prescription or refills, according to a 2016 survey. The main barriers were found to be a lack of insurance, not having a regular doctor, and difficulty making an appointment.


The recent FDA application comes in the wake of the US Supreme Court overturning Roe vs Wade, one of the biggest blows to abortion rights in US history. By potentially making this highly effective contraception easily available in pharmacies and supermarkets, the Perrigo company says they hope to provide people with more autonomy over their reproductive system. 

"This historic application marks a ground-breaking moment in contraceptive access and reproductive equity in the U.S.," Frédérique Welgryn, Chief Strategic Operations and Innovation Officer at HRA Pharma, said in a statement. "More than 60 years ago, prescription birth control pills in the U.S. empowered women to plan if and when they want to get pregnant. Moving a safe and effective prescription birth control pill to OTC [over-the-counter] will help even more women and people access contraception without facing unnecessary barriers."


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