FDA advisers recommend the agency approve the first over-the-counter birth control pill

Ahead of the advisory committee meeting, HRA Pharma conducted a clinical trial attempting to assess how well consumers would correctly identify if they should take the pill, and if so, whether they could correctly take it at around the same time every day. The trial initially included more than 1,700 participants and ultimately followed 883 participants who logged electronically when they took the pills.

HRA Pharma concluded that most consumers, including adolescents and people with limited health literacy, would take the pill as instructed or use alternative contraception if they didn’t.

But FDA scientists had concerns over HRA’s data, including that patient-reported diaries are often unreliable. Many study participants, for example, reported in their e-diaries taking more daily pills than were available. HRA Pharma attributed this to most likely a user error, while FDA scientists said it could be a sign of serious misuse of the pill. The agency also said that there was a high potential for people with contraindications, such as a history of breast cancer or unexplained vaginal bleeding, to take the pill, or that adolescents or people with low health literacy would try to use the pill as an emergency contraception.

What’s next: The recommendations are not binding, though the FDA often follows them. The FDA is expected to decide whether Opill should be offered over the counter this summer.

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