If approved, Opill would become the first contraceptive pill to be moved out from behind the pharmacy counter onto store shelves or online.
The Supreme Court on Friday preserved women’s access to a drug used in the most common method of abortion, rejecting lower-court restrictions while a lawsuit continues.
The agency will ask the panel to consider whether younger teenagers will be able to understand and follow the instructions. The company's application has no relation to the ongoing lawsuits over the abortion pill mifepristone, which is not a contraceptive. Research for over-the-counter use 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.Many common medications have made the over-the-counter switch, including drugs for pain relief, heartburn and allergies.
But after Perrigo wrapped up its study, the FDA identified a problem: nearly 30% of women erroneously reported taking more pills than they were actually supplied.Perrigo will present a reanalysis of the data that excludes the participants who overreported. The company says the results showed the study still achieved its goal of demonstrating that most women used the pill correctly.Women reported taking the pill on a daily basis 92% of the time during the study, the company says.
France Dernières Nouvelles, France Actualités
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