Food and Drug Administration advisers on Wednesday unanimously recommended the agency approve the nation’s first over-the-counter birth control pill, although it’s unclear what the FDA will ultimately decide in the coming months.
The 17-0 vote capped a two-day joint committee meeting where FDA officials and Perrigo Co. PLC subsidiary HRA Pharma sparred over each other’s interpretation of safety and efficacy data of the progestin-only Opill. It was approved as a prescription drug in 1973, but the joint committee was tasked with assessing whether consumers would use the pill properly if it were sold on store shelves without a prescription.
FDA officials said they understood the importance of over-the-counter contraceptives, but were struggling with what they called flaws in the company’s data. A final decision is expected by the end of summer.
