Federal health advisers are recommending that a decades-old birth control pill be sold without a prescription.
The positive vote came despite numerous criticisms from FDA scientists about how Perrigo studied the drug, including whether study participants were able to understand and follow labeling instructions.
But the panel largely set those concerns aside, emphasizing the benefits of providing more effective birth control, particularly to young people and lower-income groups, than what's available over the counter now, like condoms and diaphragms. Most birth control pills used in the U.S. today contain a combination of progestin and estrogen. Opill is part of an older class of contraceptives that only contain progestin. They generally have fewer side effects and health risks but can be less effective if they're not taken around the same time daily.
Nonprescription medicines are usually cheaper, but generally not covered by insurance. Requiring insurers to cover over-the-counter birth control would require a regulatory change by the federal government. Birth control pills are available without a prescription across much of South America, Asia and Africa.
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FDA panel backs over-the-counter birth control pillFederal health advisers are recommending that a decades-old birth control pill be sold without a prescription
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FDA panel backs over-the-counter birth control pillFederal health advisers are recommending that a decades-old birth control pill be sold without a prescription. The positive vote on Wednesday by a Food and Drug Administration panel paves the way for what could be the first birth control pill available over the counter. The recommendation is not binding and the FDA is expected to make its decision on the drug this summer. Currently all contraceptive pills in the U.S. require a prescription. Dozens of medical and advocacy groups support making the pill available without a prescription to increase birth control options for women.
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FDA Panel Backs Over-The-Counter Birth Control PillFederal health advisers are recommending that a decades-old birth control pill be sold without a prescription.
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FDA panel backs over-the-counter birth control pillU.S. Food and Drug Administration advisers endorsed the first over-the-counter sales of a birth control pill, with a final decision expected this summer.
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FDA panel backs over-the-counter birth control pill, teeing up approvalBREAKING: An FDA panel voted to back the sale of an over-the-counter birth control pill, clearing the way for approval.
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FDA panel backs over-the-counter birth control pillIf the agency follows the nonbinding recommendation, Perrigo’s drug, Opill, would become the first contraceptive pill to be moved out from behind the pharmacy counter onto store shelves.
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