, which is not a contraceptive. Research for over-the-counter sales of the pill began nearly a decade ago.
FDA's decision won't apply to other birth control pills, only Opill, although advocates hope that an approval decision might push other pill makers to seek over-the-counter sales. Birth control pills are available without a prescription across much of South America, Asia and Africa. Women were paid to track and record their use of the pill, including whether they followed instructions to take it during the same 3-hour window each day. That consistency is key to the drug’s ability to block pregnancy.
Opill contains only progestin, making it a safer option and, according to experts, an easier regulatory switch to over-the-counter status. But progestin-only pills have downsides, including reduced effectiveness if they’re not taken at the same time daily.
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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.
Source: ABC - 🏆 471. / 51 Read more »
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
Source: WOKVNews - 🏆 247. / 63 Read more »
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.
Source: AP - 🏆 728. / 51 Read more »