An FDA advisory panel on Wednesday 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.
The advisors’ vote is not binding, and 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.
“For a product that has been available for the last 50 years, that has been used safely by millions of women, we thought it was time to make it more available,” Frederique Welgryn, chief strategy officer of HRA Pharma, a French drugmaker owned by the pharmaceutical company Perrigo, when the company announced the application for over-the-counter use.
FDA raises 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.
The FDA review also noted that “the degree to which efficacy of (the pill) is diminished in individuals who are overweight or obese…remains unknown.”
But the American College of Obstetricians and Gynecologists has cited several studies showing that “women with obesity can be offered all hormonal contraceptive method options with reassurance that the efficacy of hormonal contraception is not significantly affected by weight.”
“We have no doubt that our data clearly shows that women of all ages can safely use Opill in the over-the-counter setting,” Welgryn said.
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.
“Access to oral contraceptives without a physician’s prescription is a safe and necessary step that we must take to ensure that individuals are able to effectively limit unintended pregnancies and manage their reproductive choices, which is now particularly important as those choices are being limited in many states,” the AMA said in comments submitted to the FDA, noting the pill’s 60-year history.
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.
“It’s time to free the pill and ensure that those who have long faced the most barriers to care due to systemic inequities have access to an over-the-counter birth control pill that is priced affordably and covered by insurance,” Victoria Nichols, project director of Free the Pill, said in a statement. “The days of the current prescription requirement – a barrier that disproportionately impacts Black, Indigenous, Latina/x, Asian Americans, Native Hawaiian and Pacific Islander communities, LGBTQ+ folks, young people, people with disabilities, and those working to make ends meet – are numbered.”
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.
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.
Contributing: The Associated Press
USA TODAY
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