F.D.A. Advisors say benefits of over-the-counter birth control pill outweigh risks

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

< p class="css-at9mc1 evys1bk0">A group of Food and Drug Administration advisers voted unanimously on Wednesday that the benefits of making a birth control pill available without a prescription outweigh the risks, an important step in the decades-long push to make the oral contraceptive pill available without a prescription in the United States.

If the F.D.A. approves the sale of the drug, called Opill, without a prescription this summer, it could dramatically expand access to contraception, especially for young women and those who have difficulty managing the time, cost or logistical hurdles of a doctor's visit, say reproductive health experts.

"I believe Opill has the potential to have a huge positive impact on public health," said advisory board member Kathryn Curtis, a scientist at health at the Centers for Disease Control and the Division of Reproductive Health Prevention.

Approval is not a foregone conclusion, however. F.D.A. scientists who analyzed data submitted by the pill's maker, HRA Pharma, raised concerns about whether women with medical conditions that should prevent them from taking the pill - primarily breast cancer and undiagnosed vaginal bleeding - would follow warnings and avoid the product.

The agency's reviewers also questioned whether company research reliably demonstrated that consumers would follow the label instructions to take the pill at around the same time each day and to use another form of birth control or abstain from sex if they happen to miss a dose. The F.D.A. analysts also raised questions about whether young teens and people with low literacy could follow the instructions.

“The F.D.A. has been put in a very difficult position to try to determine whether it is likely that women will use this product safely and effectively over the counter," said Dr. Karen Murry, deputy office manager. over-the-counter drugs from the F.D.A., during the advisory panel discussion session on Wednesday afternoon.

"We can't just approve it based on experience in the prescription setting without the plaintiff doing adequate studies to examine what is likely to happen in the non-prescription setting," she said. "But I wanted to re-emphasize that the F.D.A. realizes how very important women's health is and how important it is to try to increase access to effective contraception for American women. were vastly overwhelmed by public health needs in a country where nearly half of all pregnancies are unintended and by the long history of safety and efficacy of Opill, which has been approved for prescription use 50 years ago.

"The panel expresses confidence in the effectiveness, not only in the general population of women, but also in adolescent populations and people low literacy," said Maria Coyle, the committee's chair, a pharmacist and associate clinical professor at Ohio State University. "The panel seems very comfortable with the limited number of risks associated with the drug itself."

Several panelists said that Opill might actually be the safer for teenagers because they are very unlikely to have breast cancer, the main medical condition that prevents taking hormonal contraception.

“Teenagers really need it urgently,” said Dr. Leslie Walker-Harding, a panelist specializing in adolescents. Medicine and Director of Studies and Senior Vice President of Seattle Children's Hospital. Young people often start with contraception they can buy over-the-counter, and other such methods, including condoms, are much less effective than pills, which prevent pregnancy in 93% of cases with one use. typical.

Most adolescents have "none or less effective birth control methods available to them," Dr. Walker-Harding said, adding that " it would greatly increase the ability of children not to have unwanted pregnancies."

Panelists included obstetrician-gynecologists, adolescent medicine specialists, a breast cancer specialist and consumer health experts...