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FDA panel recommends first over-the-counter birth control pill

EITHERn May 10, a panel of experts from the US Food and Drug Administration (FDA) voted unanimously to make an oral contraceptive pill available without a prescription. If the FDA adopts the panel’s recommendation, the birth control pill, currently only available by prescription, would become the first oral contraceptive that women can take without medical supervision.

“This represents a milestone in the history of women’s health,” said Dr. Margery Gass, professor emeritus of obstetrics and gynecology at the University of Cincinnati and an FDA panel member in explaining her vote for the medicine, called Opill, is available without a prescription. Counter.

The recommendation comes at a precarious time for the reproductive health of women in the US after decades of federal abortion rights were outlawed. tipped overstates are instituting new abortion bansand access to the abortion pill mifepristone is in a legal limbo. The need for an accessible form of contraception without a prescription that is more effective than currently available methods, such as condoms, was a major factor in the committee’s decision.

Although the 17 panel members, who were independent experts in women’s health and patient behavior, voted unanimously, they had concerns about some of the data that Opill’s maker, HRA Pharma Perrigo, presented to support its change. to non-prescription status. . The FDA scientists raised questions about the validity of the main study showing that women can safely and effectively take the pill without the help of medical professionals, and disagreed with some of the company’s interpretations of that data. .

Because Opill is already an approved prescription drug, the FDA panel focused primarily on whether women could, on their own and without the supervision of a doctor or pharmacist, safely and effectively take the pill. The panel considered whether women would use the drug appropriately and whether women for whom the drug is not recommended, including those with breast cancer and those with abnormal bleeding between periods, would know from the package label that taking the drug would be dangerous. potentially risky. for them. (Because Opill is progestin-based, it is not indicated for women currently receiving treatment or with a history of breast cancer, as some breast tumors are fueled by the hormone.) they would read the medication label and how well they understood the instructions and warnings on its use.

Read more: All Types of Hormonal Birth Control Share a Slightly Increased Risk of Breast Cancer, Study Finds

The FDA found that the company interpreted the data in ways that inflated understanding and adherence. For example, about half of the women originally enrolled in the study dropped out — a percentage the company says reflects real-world pill-taking cessation, but which the FDA found contributed to the data. of results were not reliable. The FDA also raised concerns that approximately one-third of the women in the study reported taking more doses in their electronic diaries than were provided, prompting additional questions about whether the women would adequately and consistently take the pills. by themselves. They were also concerned that adolescents and people with lower basic health knowledge, for whom the label directions might not be enough, might also use the drug inappropriately.

For these reasons, FDA panel members found that the studies the company conducted were mixed or did not support such unsupervised use.

But despite their concerns about data collection, the committee decided that, overall, the potential benefits of over-the-counter birth control pills, including increased access to birth control and fewer unintended pregnancies, outweigh the risks. potential for inappropriate use. Many doctors on the panel also acknowledged that women currently prescribed Opill don’t get much additional counseling or more visits and often only see their doctors once a year for refills. “There is no evidence that women use the drug correctly or that they are best managed by a medical professional,” said Dr. Leslie Walker-Harding, professor and director of pediatrics at the University of Washington, explaining her vote for the drug. change.

During the open public hearing, women’s reproductive rights advocates, patient groups, and health experts argued that having this option is critical for women to make informed reproductive decisions. The American College of Obstetrics and Gynecology (ACOG), the American Medical Association, and the American Academy of Family Physicians, among others, endorse an over-the-counter birth control option. “Our patients are now smarter than ever with all the information available through multiple channels,” Dr. Aparna Sridhar, an associate professor of obstetrics and gynecology at the University of California, Los Angeles, tells TIME.

“This is a patient empowerment issue,” said Dr. Kristyn Brandi, an assistant professor of obstetrics, gynecology and women’s health at the New Jersey Medical School during a briefing unrelated to the committee meeting. “I want my patients to choose what works best for them. I trust my patients to take a prescription and use it as directed on the label. That doesn’t change if they access an over-the-counter medication.”

The committee’s recommendation now goes to the FDA commissioner, who will make the final decision on whether to approve a change from prescription to over-the-counter status.

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