Sale of over-the-counter birth control pill backed by U.S. FDA panel
pill should be sold without a prescription, paving the way for a likely U.S. approval of the first over-the-counter contraceptive medication.advisers voted unanimously in favor of drugmaker Perrigo’s request to sell its once-a-day medication on store shelves alongside eye drops and allergy pills. The recommendation came at the close of a two-day meeting focused on whether women could safely and effectively take the pill without professional supervision.
The positive vote came despite numerous criticisms from FDA scientists about how Perrigo studied the drug, including questions about whether study participants were able to understand and follow labeling instructions.“We have an application with many complicated issues and uncertainties, including questionable reliability,” FDA’s Dr. Pamela Horn told panelists on Tuesday.
Opill was first approved in the U.S. five decades ago based on data showing it was more than 90% effective in preventing pregnancy when taken daily. Even if the pill is approved for over the counter, it’s unclear how popular it might be. Opill has not been marketed in the U.S. since 2005. Perrigo said its 880-patient study of the drug showed that women will consistently take the pill daily if it’s made available over-the-counter. But the FDA found several problems in the study, including more than 30% of participants who erroneously reported taking more pills than they were actually supplied. FDA reviewers said the problem called into question the company’s overall conclusions about the drug’s use and effectiveness.
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