FDA scientists raised concerns about whether the general public will understand the drug label and use HRA Pharma's Opill in the right way.
The FDA is not obligated to follow the recommendations of its independent advisors, all 17 of whom voted "yes" on the proposal.
The FDA originally approved norgestrel in 1973 as a prescription drug. But the company stopped U.S. sales of the pill in 2005 for business reasons, according to the agency. "This is a critical issue for reproductive health, rights, and justice," the lawmakers wrote in a letter to Califf. The fall of Roe v. Wade led some states to ban abortion or place tight restrictions on the procedure. It also led to legal efforts to pull abortion medication from the U.S. market.
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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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Feds turn antitrust focus to digital pharma adsThe investigation into health data giant IQVIA’s ad tech deal focuses on harm to rivals and increased costs for drugmakers.
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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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FDA Experts to Consider First Over-the-Counter Birth Control PillAs a U.S. Food Drug Administration advisory panel prepares to weigh whether to recommend that a birth control pill be sold over the counter in this country, a coalition of advocates on Monday called attention to the safety and effectiveness of the medication.
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‘Caught between a rock and a hard place’: FDA considers over-the-counter birth controlThe agency is slated to make a decision on approval of the daily hormonal pill by this summer.
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