FDA panel recommends allowing birth control pill to be sold over the counter

An FDA advisory panel on Wednesday unanimously recommended the agency allow a birth control pill to be available over the counter in the U.S. for the first time.

The panel came to the decision after a two-day public meeting mostly centered on if people could safely and effectively take the birth control drug Opill without professional supervision. Experts on the panel said they were confident they could, and the benefits of making the pill more widely available far outweigh any risks.

The advisors' decision is not binding, but the 17-0 vote paves the way for the likely approval of the pill's over-the-counter availability. The FDA is expected to make a final decision this summer.

If the application is approved, Opill will be the first contraceptive pill to be sold over the counter in the United States. It would join emergency contraceptives like Plan B on pharmacy shelves.

Kathryn Curtis, a scientist at the Centers for Disease Control and Prevention who was part of the panel, said selling Opill over the counter has the "potential to have a huge public health impact," adding that "the large body of evidence on the safety and effectiveness is very reassuring."

"The evidence demonstrates that the benefits clearly exceed the risks," Curtis said. "The benefits of moving Opill over the counter include increased access to contraception…, reduction in unintended pregnancy and associated risks, and improved reproductive autonomy and improved equitable access to contraception."

This illustration provided by Perrigo in May, 2023, depicts proposed packaging for the company's birth control medication Opill.

FDA raised concerns in initial review

The decision comes after the FDA raised numerous concerns in an initial review over the drugmaker Perrigo's application to sell Opill over the counter.

Their main concerns included if people, especially young teenagers, would be able to correctly follow the labeling directions, and if people may not realize when Opill isn't appropriate for them without counseling from a doctor.

For example, people with a history of breast cancer should not take the pill, and those with abnormal vaginal bleeding should talk to a doctor first. But some participants in these categories incorrectly said Opill would be appropriate for them in preliminary research.

Free the Pill and other advocacy groups that support improving access to contraceptives rallied outside the White House on Monday in support of making Opill available over the counter.

The panel largely set aside initial concerns Wednesday when given the opportunity to ask questions about Perrigo's research.

"The history of women’s contraception is a struggle for women’s control over their reproduction, and we need to trust women," said Dr. Katalin Roth, a professor of medicine at George Washington University and a member of the advisory panel.

Murray S. Kessler, CEO and president of Perrigo, said the vote is the start of a "new, groundbreaking chapter in reproductive health."

Medical organizations react to birth control pill vote

For years, medical organizations and advocates for increasing access to birth control have pushed to have over-the-counter birth control pills available in the United States.

Medical organizations, including the American Medical Association, the American College of Obstetricians and Gynecologists support selling the birth control pill over the counter.

Free the Pill and other advocacy groups that support improving access to contraceptives rallied outside the White House on Monday in support of making Opill available over the counter.

Victoria Nichols, project director of Free the Pill, called the Wednesday vote "a historic step forward for reproductive health."

"Decades of coalition-driven advocacy and research efforts that have centered the voices of those most impacted by barriers to contraception caused by systemic inequities have made this possible," Nichols said in a Wednesday statement. "It is past time for an over-the- counter birth control pill, which has the potential to advance reproductive justice and expand health equity.

A 2015 study in the Journal of Women's Health found that nearly one-third of adult women who have tried to get birth control pills have faced problems obtaining a prescription or refills. They faced challenges including scheduling an appointment in time, getting to a clinic, paying for pills or accessing insurance. Uninsured and Spanish-speaking women were more likely to report difficulties, according to the study.

"For too long, barriers to birth control, including the prescription requirement, have prevented people from getting the contraceptive care they need, with the barriers falling hardest on Black, Indigenous, Asian American, Native Hawaiian, and Pacific Islanders, Latinx folks and other people of color," said Monica Simpson, executive director of the reproductive justice organization SisterSong.

Free the Pill and other advocacy groups that support improving access to contraceptives rallied outside the White House on Monday in support of making Opill available over the counter.

How does birth control pill Opill work?

Opill uses the synthetic hormone progestin to block sperm from the cervix, preventing pregnancy. Most other birth control pills use progestin and estrogen, and progestin-only pills like Opill are often recommended for people who can't take combination pills because of health reasons.

Hormone-based pills, like Opill, have long been among the most common forms of birth control nationwide and have been used by tens of millions of people since the 1960s.\

Opill was first approved in the U.S. in 1973. The pill is currently sold without a prescription in the United Kingdom. Other contraceptive pills are available without prescription across much of the globe, including in South America, Asia and Africa.

Dig deeper: Reproductive rights

Contributing: The Associated Press

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