The Food and Drug Administration (FDA) may approve birth control pills over-the-counter by the summer, but they expressed hesitation due to concerns over errors in submitted data on the drug's safety.
An advisory committee to the FDA met Tuesday to make a recommendation on whether a historic approval of over-the-counter birth control drugs is safe for consumers. HRA Pharma requested its contraceptive drug, Opill, generically known as norgestrel, to be made available over-the-counter weeks after the Supreme Court overturned Roe v. Wade. However, the agency expressed worries that access to the drug without a prescription may lead to increased errors in usage, according to a public briefing of Tuesday's meeting.
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Labels for norgestrel detail the importance of property timed usage, risk of recurring breast cancer and a need to consult a doctor about usage if struggling with vaginal bleeding.
The FDA noted HRA Pharma's submitted data on norgestrel revealed consumers reported taking more doses of the drug than they received. This error, which the agency referred to as "improbable dosing," led them questioning "whether any of the data" can be "relied upon to demonstrate appropriate use in the study population."
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"The reasons why improbable dosing occurred are not evident, but the results reveal that the actual use of the drug was not well documented because what was documented was not possible," the agency stated in the meeting briefing. "Because the reported dosing was not possible, it leaves us with no clarity on what one-third of study participants actually took – or if they took any drug at all."
Norgestrel should not be taken by women with a history of breast cancer due to risk of tumors recurring. HRA Pharma said 97% of 206 participants in a study of breast cancer survivors chose not to take the drug after reading its label.
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The FDA, though, criticized the submitted data over an underestimate of participants with limited literacy. And staffers at the agency noted that the data is more than two decades old. More data would be useful, the agency said, to measure efficacy concerns over the impact of increased obesity and improper usage.
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The advisory committee to the FDA meets again Wednesday before it makes a recommendation on the drug's status.
