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U.S. considers over-the-counter birth control pills for the first time ever

The Paris-based HRA Pharma submitted an application to the Food and Drug Administration to sell its Opill birth control over the counter

July 12, 2022 6:44am

Updated: July 13, 2022 10:14am

For the first time ever, the United States will be considering selling birth control pills over the counter, weeks after the Supreme Court overturned the right to abortion. 

Sixty years after the U.S. Food and Drug Administration (FDA) approved birth control pills, buyers still require a prescription. However, more than 100 countries worldwide allow the sale of oral contraceptives without a prescription. 

Several medical organizations in the U.S., including the American Medical Association and the American Academy of Family Physicians, have asked the U.S. government to follow in the footsteps of other countries and allow the sale of the pill without a prescription.

They might be see it happen sooner rather than they think.

The Paris-based HRA Pharma submitted an application to the Food and Drug Administration to sell its Opill birth control over the counter—a move that no company has previously done.

“We’re very proud of being the first company to submit the first-ever application to the FDA for daily birth control over the counter, and obviously it’s coming at the right moment,” said Frédérique Welgryn, chief strategic operations and innovation officer at HRA Pharma.

"Moving a safe and effective birth control pill to OTC [over the counter] will help even more women and people access contraception without facing unnecessary barriers," added Welgryn. 

The pharmaceutical says that the FDA should reach its decision by next year. To sell the pill over the counter, the FDA requires that the medicine be safe, must treat a condition it must diagnose, has a low potential for misuse, and can be used without the supervision of a health care provider. 

The French company’s application comes at a time when reproductive rights are being debated in the United States, after the Supreme Court overturned Roe v. Wade and ruled that there is no longer a federal constitutional right to an abortion. 

While the pharmaceutical company claimed that its decision to submit its application to the FDA was not influenced by the Supreme Court’s decision, many U.S. lawmakers have been calling on the administration to review applications for over-the-counter birth control.