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

In a survey by the health care research organization KFF, more than three-quarters of women of reproductive age favored an over-the-counter pill, primarily because of convenience.

While some Catholic organizations have spoken out against over-the-counter birth control, most anti-abortion groups have been quiet on the issue. A vast majority of hundreds of comments submitted before the hearing supported approval of Opill. So did most of the 37 people who spoke during the hearing’s public comment portion on Tuesday, including young women who gave impassioned testimony about facing challenges obtaining prescription pills.

For proponents of over-the-counter pills, the main issue is affordability.

“This will not be a win if it is not affordable, covered by insurance and available to folks of all ages,” Kelly Blanchard, the president of Ibis Reproductive Health, said at a briefing on Monday organized by Free the Pill, a pro-over-the-counter coalition.

The Affordable Care Act requires only coverage of prescription contraception, and although some states have laws mandating coverage of over-the-counter methods, most states do not. The KFF survey found that 10 percent of women would not be able or willing to pay any out-of-pocket cost. About 40 percent would pay $10 or less per month, and about a third would pay $20 or less.

Frédérique Welgryn, the global vice president for women’s health at Perrigo, which owns HRA Pharma, said recently that the company planned to “make sure that the product is affordable to women” and that it would have a consumer assistance program.

Opill is known as a “mini pill” because it contains only one hormone, progestin, in contrast to “combination” pills, which contain both progestin and estrogen. A company that makes a combination pill, Cadence Health, has also been in discussions with the F.D.A. about applying for over-the-counter status.

HRA Pharma reported that participants in a study took Opill on 92.5 percent of the days they were supposed to take it. Most participants who missed a pill reported that they had followed the label’s directions to take mitigating steps such as abstaining from sex or using a condom, said Dr. Stephanie Sober, the company’s U.S. medical liaison. She said that among 955 participants, only six became pregnant while using Opill.

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