Federal health advisers said that a decades-old birth control pill should be sold without a prescription, paving the way for a likely U.S. approval of the first over-the-counter contraceptive medication.
WASHINGTON — Federal health advisers said Wednesday that a decades-old birth control pill should be sold without a prescription, paving the way for a likely U.S. approval of the first over-the-counter contraceptive medication.
“In the balance between benefit and risk, we’d have a hard time justifying not taking this action,” said Maria Coyle, an Ohio State University pharmacist, who chaired the panel. “The drug is incredibly effective, and I think it will be effective in the over-the-counter realm just as it is in the prescription realm.”
FDA’s decision won’t apply to other birth control pills, only Opill, although advocates hope that an approval decision might push other drugmakers to seek over-the-counter sales. Birth control pills are available without a prescription across much of South America, Asia and Africa. Panel members said almost all women with a history of breast cancer would be under the care of a cancer specialist, who would advise them not to take hormonal drugs that could make their condition worse.
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