U.S. health regulators are considering the first-ever request to make a birth control pill available without a prescription.
Advisers to the Food and Drug Administration will meet next week to review drugmaker Perrigo's application to sell a decades-old pill over the counter. The two-day public meeting is one of the last steps before an FDA decision.
At the end of the meeting, the FDA panel will vote on whether the benefits of making the pill more widely available outweigh the potential risks. The panel vote is not binding and the FDA is expected to make its final decision this summer. Hormone-based pills, like Opill, have long been the most common form of birth control in the U.S., used by tens of millions of women since the 1960s.
Perrigo's main study tracked nearly 900 U.S. women taking its pill without professional supervision for up to six months. The group included women of different ages, races, educational and cultural backgrounds.
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FDA considers whether a birth control pill could be sold over the counterThe FDA is on the cusp of deciding whether at least one type of hormonal birth control — a progestin-only drug called Opill by French drugmaker HRA Pharma — is safe enough to be sold over the counter without a prescription and without age restrictions.
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FDA weighing 1st over-the-counter birth control pillU.S. health regulators are weighing the first-ever request to make a birth control pill available without a prescription
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FDA weighing 1st over-the-counter birth control pillThe FDA panel will vote on whether the benefits of making the pill more widely available outweigh the potential risks.
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FDA weighs over-the-counter birth control pillIf approved, Opill would become the first contraceptive pill to be moved out from behind the pharmacy counter onto store shelves or online.
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FDA weighing 1st over-the-counter birth control pillU.S. health regulators are weighing the first-ever request to make a birth control pill available without a prescription. On Friday, the Food and Drug Administration posted its initial review of a decades-old pill that could become the first drug of its kind to move over the counter. But the agency flagged concerns about the application from drugmaker Perrigo, including problems with the reliability of some of the company's data and signs women had trouble understanding the labeling instructions. An FDA advisory panel will vote next week on whether it should be approved for over-the-counter use. The meeting is one of the last steps before an FDA decision.
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FDA weighing 1st over-the-counter birth control pillThe FDA panel will vote on whether the benefits of making the pill more widely available outweigh the potential risks.
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