FDA postpones meeting to review over-the-counter birth control pills
The Food and Drug Administration on Wednesday indefinitely postponed a meeting of outside experts to help decide whether to allow over-the-counter sales of birth control pills.
Driving the news: HRA Pharma sought the designation last July for its Opill contraceptive. The scheduling of an advisory committee meeting for Nov. 18 was considered unusually fast for the agency.
State of play: Consumer products giant Perrigo, which owns HRA Pharma, said that the FDA postponed the meeting to "review additional information requested related to the Opill Rx-to-OTC switch."
- The FDA didn't set a new date, but a decision on the Opill is still expected at some point next year.
What they're saying: "Protection of women’s health is of high importance to FDA," an FDA spokesperson told Axios.
- "The postponement does not indicate or affect any decision regarding the application," the spokesperson said, and added that the agency "remains committed to a timely review of this application."
Between the lines: Normally, the FDA looks to review and act on applications of this kind within 10 months of a company filing.
Supporters of OTC birth control urged the agency to set a new date immediately and continue scientific reviews.
- "Now more than ever, we need to increase access to the contraception people want and need," said Ibis Reproductive Health, which partnered with HRA Pharma to conduct research on the Opill.