FDA advisory panel recommends over-the-counter birth control pills
Brady Knox
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The United States Food and Drug Administration endorsed allowing birth control medication to be sold as an over-the-counter product.
A 17-member FDA advisory panel unanimously endorsed the non-prescription use of HRA Pharma’s Opill on Wednesday, clearing the way for the contraceptive to be the first available to be purchased over the counter. The company expects a final decision to be made during the summer, Axios reported.
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Activists have pushed for the decision in order to make contraceptives more easily available to more women.
The speakers at the panel “really brought home to all of us how much we have to do to repair our broken health system and how poorly we have made access to health care available for so many young women, adolescents, older women,” FDA adviser and George Washington University professor Katalin Roth told the outlet. “Approving this pill to be available over-the-counter will go towards rectifying that.”
The panel decided that the benefits, mainly increasing access to contraception, outweighed the potential harms.
Dr. Karen Murry, deputy director of the FDA’s office of nonprescription drugs, called the decision “very difficult.”
“The FDA has been put in a very difficult position of trying to determine whether it is likely that women will use this product safely and effectively at the nonprescription setting,” Murry said, the New York Times reported.
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“We can’t just approve it based on the experience in the prescription setting without the applicant doing adequate studies to look at what’s likely to happen in the nonprescription setting,” she continued. “But I wanted to again emphasize that FDA does realize how very important women’s health is and how important it is to try to increase access to effective contraception for U.S. women.”
The Washington Examiner reached out to HRA Pharma and the FDA for comment.