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FDA advisers endorse over-the-counter sales of birth control pill

In the U.S., contraceptive pills require a prescription, unlike in over 100 countries where oral contraceptives are available over-the-counter.
FDA advisers endorse over-the-counter sales of birth control pill
Posted at 5:53 PM, May 10, 2023

A U.S. Food and Drug Administration advisory panel has unanimously recommended making a long-standing birth control pill available for purchase without a prescription.

The significant vote by a panel on Wednesday opens the possibility of the first over-the-counter sales of the once-a-day birth control pill Opill by drugmaker Perrigo.

The panel stated during a joint meeting to cast their votes that they believed the public had enough data to be confident enough to use the drug on their own without seeing a health provider. 

"I believe that the efficacy and safety of this birth control form was established over half a century ago, and we now have been presented with ample data and demonstrating the effective safe use and benefits of this medication for the people who want to have access to reproductive autonomy," said Dr. Jolie Haun, a panelist who voted in favor of the pill, during a joint meeting. 

SEE MORE: FDA raises concerns about over-the-counter birth control pill

Although the recommendation is not binding, the FDA is anticipated to announce its decision on the matter later this summer, and if approved, sales of the drug could start late this year.

Opill was first approved by the FDA in 1973 but has always required a prescription. Currently, all contraceptive pills in the U.S. require a prescription. 

While the FDA’s decision on Opill won’t apply to other brands of birth control drugs, medical and advocacy organizations back the idea of non-prescription access to the pill, aiming to expand birth control choices for people in the U.S. In over 100 other countries, including the U.K., oral contraceptives are already available over-the-counter.

"The benefit of Opill being available to diverse populations, including adolescents and those with limited literacy, is in demand," said Dr. Haun. "We do have the data that reflects the ability to make this medication and the birth control pill available over the counter. We can take this opportunity to increase access, reduce disparities, and, most importantly, increase the reproductive autonomy of the women of our nation."


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