Federal health advisers said Wednesday that a decades-old birth control pill should be sold without a prescription.
The outside experts said they were mostly confident that women of all ages could use the drug appropriately without seeing a health provider first.
“We have an application with many complicated issues and uncertainties, including questionable reliability,” FDA’s Dr. Pamela Horn told panelists on Tuesday. FDA’s decision won’t apply to other birth control pills, only Opill, although advocates hope that an approval decision might push other drugmakers to seek over-the-counter sales. Birth control pills are available without a prescription across much of South America, Asia and Africa.
But in reading comprehension studies conducted by Perrigo, 68% of women with unexplained bleeding incorrectly answered they could take the drug. And a few women with breast cancer also told researchers they could use Opill. 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.
“Opill over the counter would give us one more option for access and the more options that are available the better,” said Clare Coleman, president of the National Family Planning and Reproductive Health Association
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