BREAKING: An FDA panel voted to back the sale of an over-the-counter birth control pill, clearing the way for approval.
to discuss and vote over whether there was"adequate information to conclude" that the benefits of making norgestrel tablets available over-the-counter outweigh the risks of consumers taking them without a doctor's supervision.Monday it was expecting the FDA could decide on approval of over-the-counter Opill within the next three months. If approved, Opill could be rolled out as early as the end of this year, a company executive said.
This illustration provided by Perrigo in May 2023 depicts proposed packaging for the company's birth control medication Opill.While the panel's vote is not binding, the FDA says the expert input plays a key role in helping agency reviewers sort through tricky questions posed by drug company submissions. Advisers had wrestled with avoiced by the FDA's reviewers with Perrigo's request, including around whether a key study might need to be re-run.
"This finding of improbable dosing in this study is really quite extraordinary. This is not something we see in a typical actual use study. And the results have to be incredibly extreme to show up in this kind of a study," the FDA's Theresa Michelle told the panel.
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