Advisers to the FDA back first over-the-counter birth control pill

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An advisory panel to the Food and Drug Administration supported drugmaker Perrigo’s application to sell the oral contraceptive Opill without a prescription.

Perrigo


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Perrigo


An advisory panel to the Food and Drug Administration supported drugmaker Perrigo’s application to sell the oral contraceptive Opill without a prescription.

Perrigo

In a unanimous vote, 17-0, a panel of advisers to the Food and Drug Administration recommended that the agency approve the first over-the-counter birth control pill.

If approved, the pill would be sold by Perrigo under the brand name Opill. It is a so-called progestin-only pill that contains only a synthetic version of the hormone progesterone to prevent pregnancy. Most pills also contain estrogen. While the FDA typically follows the recommendation of its advisory committees, it isn’t required to.

In comments after the vote, panel members explained their support for the prescription-free pill.

“I feel that the risk of unintended pregnancy is lower with this approach than any of the other available contraceptive approaches that women have access to without seeing a health care provider,” said Dr. Deborah Armstrong, a professor of oncology, gynecology and obstetrics at Johns Hopkins. She added that she thought people would be able to understood if any health conditions they have would be incompatible with taking the pill.

“I voted yes because the evidence demonstrates that the benefits clearly exceed the risks,” said Kathryn Curtis, a health scientist with the Centers for Disease Control and Prevention’s division of reproductive health. The benefits include increased access to effective birth control, reduction in unintended pregnancies and its risks and increased reproductive autonomy. “Opill has the potential to have a huge public health impact,” she said.



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