Birth control pills should be available over the counter, an independent panel of advisers told the FDA on Wednesday, saying the benefits are greater than potential problems.
The benefits of making the birth control pill Opill available without a prescription outweigh the risks, the advisers said, according toAdvocates have wanted the change for decades, saying it could make contraception more widely available for young women and those who have a hard time reaching a doctor.
The agency is “in a very difficult position,” Deputy Director Karen Murry, MD, said during the advisory panel’s discussion. “We can’t just approve it based on the experience in the prescription setting without the applicant doing adequate studies to look at what’s likely to happen in the nonprescription setting,” she said. “But I wanted to again emphasize that F.D.A. does realize how very important women’s health is and how important it is to try to increase access to effective contraception for U.S. women.”
The advisory panel said the public health need is great and that Opill, which is made by HRA Pharma and was approved about 50 years ago, is safe and effective.
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