If approved, Opill, a daily progestin-only birth control pill, would become the first such drug sold over the counter in the United States.
“For many, these barriers include the cost and time associated with a health care visit to get a prescription, transportation to that visit, finding childcare during the appointment for parents, and parental consent for young people," said Victoria Nichols, project director of FreeThe FDA isn't obligated to follow the guidance of its advisory panels, but it typically does.
Exactly how the panel will vote on Wednesday is unknown, but there have been some signals to suggest members may be skeptical. In briefing documents filed before the meeting, FDA officials raised concerns about whether people will use these pills appropriately. The label suggests that pills must be taken at the same time every day, and there isn't enough information about what could happen if someone misses this window. There's also a risk of
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FDA may allow birth control pill without prescription this summer as experts weigh dataHRA Pharma asked the Food and Drug Administration to allow over-the-counter sales of Opill after the Supreme Court said there was no federal right to abortion.
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FDA raises concerns about over-the-counter birth control pillU.S. regulators will vote this week on whether the contraceptive Opill should be made widely available without a prescription.
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FDA advisory committees meeting to discuss over-the-counter birth controlAdvisory committees of the U.S. Food and Drug Administration are meeting Tuesday and Wednesday to review the first-ever application for an over-the-counter birth control pill.
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