F.D.A. Advisers Say Benefits of Over-the-Counter Birth Control Pill Outweigh Risks

NYT HEALTH: F.D.A. Advisers Say Benefits of Over-the-Counter Birth Control Pill Outweigh Risks
By Pam Belluck
Section: Health
Source: New York Times
Published Date: May 10, 2023 at 03:00AM

The agency is expected to decide this summer whether to allow the first nonprescription sales of an oral contraceptive in the United States.

A panel of advisers to the Food and Drug Administration voted  unanimously on Wednesday that the benefits of making a birth control pill available without a prescription outweigh the risks, a significant step in the decades-long push to make oral contraception obtainable over the counter in the United States. If the F.D.A. approves nonprescription sales of the medication, called Opill, this summer, it could significantly expand access to contraception, especially for young women and those who have difficulty dealing with the time, costs or logistical hurdles involved in visiting a doctor, reproductive health experts say. Approval is not a foregone conclusion, however. F.D.A. scientists who analyzed data submitted by the pill’s maker, HRA Pharma, have raised concerns about whether women with medical conditions that should preclude them from taking the pill — primarily breast cancer and undiagnosed vaginal bleeding — would avoid the product. The agency’s reviewers also questioned the reliability of the data from a company study that was intended to show that consumers would follow the label’s directions to take the pill at roughly the same time every day and use another form of contraception or abstain from sex if they happened to miss a dose. The F.D.A. analysts also raised questions about whether younger adolescents and people with limited literacy could follow the directions.

Read more: https://www.nytimes.com/2023/05/10/health/fda-otc-birth-control-pill.html