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FDA advisers say the benefits of over-the-counter birth control pills outweigh the risks

A Food and Drug Administration (FDA) advisory panel voted unanimously 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 contraceptives available without a prescription in the United States.

If the FDA approves the drug, called Opill, for sale without a prescription this summer, it could significantly expand access to contraception, especially for young women and those who struggle to deal with the time, cost, or logistical hurdles involved in visit a doctor, reproductive health experts say.

“I think Opill has the potential to have a huge positive impact on public health,” said advisory committee member Kathryn Curtis, a health scientist in the division of reproductive health at the Centers for Disease Control and Prevention.

However, approval is not a foregone conclusion. FDA 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 (mainly breast cancer and undiagnosed vaginal bleeding) would follow the warnings. and would avoid the product.

Agency reviewers also questioned whether a company study reliably showed that consumers would follow label instructions to take the pill at around the same time each day and use another form of contraception or abstain from sexual intercourse. if they missed a dose. FDA analysts also raised questions about whether younger teens and people with limited literacy could follow the instructions.

“The FDA has been in a very difficult position trying to determine whether this product is likely to be used safely and effectively by women in the non-prescription setting,” said Dr. Karen Murry, deputy director of the Office of Nonprescription Drugs. FDA prescription, during the advisory panel discussion session on Wednesday afternoon.

“We can’t just approve it based on experience in the prescription environment without the applicant doing the proper studies to see what is likely to happen in the non-prescription environment,” he said. “But I wanted to emphasize again that the FDA realizes how important women’s health is and how important it is to try to increase access to effective birth control for American women.”

Advisory committee members said overwhelmingly that those concerns were far outweighed by the public health need in a country where nearly half of all pregnancies are unintended and by 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 women, but also in populations of adolescents and those with limited literacy,” said Maria Coyle, chair of the committee, a pharmacist and associate clinical professor at Ohio State. University. “The panel seems very comfortable with the limited number of risks of the drug itself.”

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

“Teens really need this badly,” said Dr. Leslie Walker-Harding, a panelist who specializes in adolescent medicine and chief academic officer and senior vice president at Seattle Children’s Hospital. Young people often start with contraceptives they can buy without a prescription, and other similar methods, including condoms, are much less effective than pills, which prevent pregnancy 93 percent of the time with typical use.

Most adolescents have “no or less effective contraceptive methods available to them,” Dr. Walker-Harding said, adding that “this would dramatically increase children’s ability to avoid unwanted pregnancies.”

Panelists included OB/GYNs, adolescent medicine specialists, a breast cancer specialist, and experts in consumer health behavior and health literacy.

Several said they believed few breast cancer patients would be at risk because their oncologists would advise them not to use the pill. And many panelists who frequently prescribe birth control pills said that because doctors typically didn’t monitor patient compliance and often only saw them annually, there was no advantage to requiring a prescription.

Since the Supreme Court struck down the nation’s right to abortion last year, the accessibility of contraception has taken on greater urgency. But even before that, the movement to make an over-the-counter pill available to all ages has garnered a flurry of support from adolescent and reproductive health specialists and groups like the American Medical Associationhe American College of Obstetricians and Gynecologists and the american academy of family physicians.

in a survey conducted by healthcare research organization KFFmore than three-quarters of women of reproductive age preferred an over-the-counter pill, primarily for convenience.

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

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

“This won’t be a win if it’s not affordable, covered by insurance and available to people of all ages,” Kelly Blanchard, president of Ibis Reproductive Health, said at a Monday briefing hosted by Free the Pill, a pro- OTC Coalition.

The Affordable Care Act requires coverage only for prescription contraceptives, and while some states have laws requiring over-the-counter coverage, most states do not. The KFF survey found that 10 percent of women could not or would not pay any out-of-pocket costs. About 40 percent would pay $10 or less per month, and about a third would pay $20 or less.

Frédérique Welgryn, global vice president for women’s health at Perrigo, which owns HRA Pharma, recently said the company planned to “make sure the product is affordable for women” and 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 talks with the FDA to apply for over-the-counter status.

HRA Pharma reported that participants in one study took Opill on 92.5 percent of the days they were supposed to take it. Most of the participants who missed a pill reported that they had followed label instructions to take mitigating measures, such as not having sex or using a condom, said Dr. Stephanie Sober, the company’s US medical liaison. She said that among 955 participants, only six became pregnant while using Opill.

Most of the people who said they had missed doses attributed it to running out of pills before they could get to one of the study refill sites, results that, Dr. Sober said, “precisely illustrate the barriers to adherence which could be reduced by switching Opill to the OTC configuration.”

But FDA reviewers were concerned that about 30 percent of participants reported taking more pills than were dispensed, a phenomenon called “overreporting” or “improbable dosing.” The reviewers wrote that “because the reported dosing was not possible, it is not clear to us what a third of the study participants actually took, or whether they took any drugs.”

Several members of the advisory committee said that the company’s data was not perfect, but that they were convinced that most people would use Opill appropriately and that the safety risks were low for those who did not.

“I think this represents a milestone in our history of women’s health,” said one panelist, Dr. Marjorie Gass, a retired obstetrician-gynecologist. “Unwanted pregnancy can really ruin a woman’s life and especially a teenager’s life. So I’m very pleased that the FDA is seriously considering this, and I hope it’s on the market.”

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