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

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.

“The F.D.A. has been put in a very difficult position of trying to determine whether it is likely that women will use this product safely and effectively at the nonprescription setting,” said Dr. Karen Murry, deputy director of the F.D.A.’s office of nonprescription drugs, during the advisory panel’s discussion session on Wednesday afternoon.

“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 committee’s members overwhelmingly said that those concerns were vastly outweighed by the public health need and the long history of safety and efficacy of Opill, which was approved for prescription use 50 years ago.

“The panel expresses confidence in the effectiveness, not only in the general population of females, but also in adolescent populations and those with limited literacy,” said Maria Coyle, the chairwoman of the committee, a pharmacist and an associate clinical professor at The Ohio State University. “The panel seems very comfortable with the limited number of risks from the medication itself.”

The advisory committee’s members included a wide range of medical professionals: obstetrician-gynecologists, adolescent medicine specialists, a breast cancer specialist and experts in consumer health behavior and health literacy.

The F.D.A. had originally scheduled the committee’s public hearing for last November, but postponed it until this spring after asking the company to submit additional information.

Since the Supreme Court overturned the national right to an abortion almost a year ago, the accessibility of contraception has taken on more urgency. The move to make a nonprescription pill available for all ages has garnered a groundswell of support from specialists in reproductive and adolescent health and groups like the American Medical Association, the American College of Obstetricians and Gynecologists and the American Academy of Family Physicians.

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. Support was expressed in the vast majority of hundreds of comments submitted before the hearing, which began on Tuesday, and by most of the 37 people who spoke during the hearing’s public comment portion.

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.

Dr. Daniel Grossman, a professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco, spoke in support of the over-the-counter effort in the advisory committee’s hearing on Tuesday. He said in an interview that both types of pills were safe and about 93 percent effective in preventing pregnancy with typical use.

Combination pills have been more popular in the United States, but that may be because progestin-only pills, which are widely used in Europe, have not been marketed much in this country, he said.

HRA Pharma, which was purchased last year by Perrigo, a Dublin-based maker of over-the-counter pharmaceuticals, already sells a nonprescription progestin-only pill in the United Kingdom.