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FDA Experts to Consider First Over-the-Counter Birth Control Pill

But some FDA officials have expressed concern that people will not use the pill appropriately or clearly understand its risks

By Physician’s Briefing Staff HealthDay Reporter

TUESDAY, May 9, 2023 (HealthDay News) — As a U.S. Food Drug Administration advisory panel prepares to weigh whether to recommend that a birth control pill be sold over the counter in this country, a coalition of advocates on Monday called attention to the safety and effectiveness of the medication.

If approved, Opill, a daily progestin-only birth control pill, would become the first such drug sold over the counter in the United States. Opill was first approved by the FDA in 1973. During a media briefing on the coming decision, the Free the Pill coalition said it hopes this pill will be fully covered by insurance and available to people of all ages and backgrounds without a prescription.

Meanwhile, the FDA expert panel will hold a two-day meeting, starting on Tuesday, to decide whether to recommend allowing Opill to be sold without a prescription. There is no precise information available on how much Opill will cost if sold over the counter, but Opill manufacturer Perrigo said in a recent statement that it is committed to making it affordable.

The American Medical Association, the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, and other medical organizations support over-the-counter access to hormonal contraception without age restrictions.

The Free the Pill coalition has been advocating for over-the-counter status for birth control pills since 2004, citing the many barriers that exist for people who want to use birth control pills, especially those from marginalized communities.

Exactly how the panel will vote on Wednesday is unknown, but there have been some signals to suggest members may be skeptical. In briefing documents filed before the meeting, FDA officials raised concerns about whether people will use these pills appropriately. The label suggests that pills must be taken at the same time every day, and there is not enough information about what could happen if someone misses this window. There is also a risk for breast cancer and undiagnosed vaginal bleeding with this pill, as well as some concern that people will not be able to evaluate these safety risks for themselves. All of these issues will be up for discussion during the two-day panel hearing.

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