By Berkeley Lovelace Jr. — NBC News
Advisers to the Food and Drug Administration voted unanimously Wednesday to recommend the sale of an over-the-counter birth control pill.
The 17-0 vote by two advisory panels came despite serious reservations from agency officials about the quality of the data used to support switching the birth control pill, called Opill, from prescription to over-the-counter. The agency was not concerned about the drug's safety and effectiveness.
The FDA is not required to follow the committees' recommendation, though the vote is expected to weigh heavily in its final decision, expected by the end of the summer. If approved, Opill, from French drugmaker HRA Pharma, would be the first over-the-counter birth control pill in the United States.
"Opill can have a huge positive impact on public health," Kathryn Curtis, a scientist at the Centers for Disease Control and Prevention, said after the vote. According to Curtis, over-the-counter of this drug will increase access and reduce unintended pregnancies.
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Advocacy groups have been pushing for an over-the-counter birth control pill for years. Many major medical organizations, such as the American Medical Association and the American College of Obstetricians and Gynecologists, support over-the-counter sales.
The meeting lasted two days and included two FDA advisory groups: the Over-the-Counter Drug Advisory Committee and the Obstetric, Reproductive and Urological Drugs Advisory Committee.
On Tuesday, FDA officials pointed to several flaws in the company's data, including a lack of information about whether women, including those with low literacy, would be able to understand the drug's instruction label. Not taking the birth control pill at the same time every day could lead to unintended pregnancies, they said.
Members of the FDA panel, however, said Wednesday they believed most women could determine for themselves whether it was appropriate to use the drug.
"We have to trust women," Dr. Katalin Roth, a professor of medicine at the George Washington University School of Medicine and Health Sciences, said after the vote. "I urge the FDA to approve it."
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HRA Pharma also noted that even when the birth control pill is prescribed, women can skip doses, citing studies according to which about 15% of women can skip three or more doses at least once a month.
Agency officials were concerned about side effects, such as vaginal bleeding, and whether users, especially teenage girls, would know how to seek help from a health professional.
Another concern was whether women with breast cancer or a history of breast cancer would know not to use the drug. Members of the FDA panel said they didn't expect that to be a problem because, they say, many women with breast cancer are aware that they should not use hormonal contraceptives.
Dr. Karen Murry, an FDA official who oversees over-the-counter drugs, acknowledged the importance of increasing access to effective contraceptives, saying the agency has been in a "very difficult position" because the company did not provide "adequate" data.
The FDA approved Opill as a prescription drug in 1973. It contains a hormone, progestin, and is taken daily.
Opill birth control pills from HRA Pharma.HRA Pharma
The shift from prescription to over-the-counter comes amid legal battles over women's reproductive rights.
Last summer, the Supreme Court overturned Roe v. Wade. Wade, which guaranteed the constitutional right to abortion. Another case, which could limit access to mifepristone, one of the drugs used in medical abortions, is making its way through lower courts.
During the FDA meeting, representatives from HRA Pharma claimed that over-the-counter contraceptives could prevent more than 37,000 unintended pregnancies in a year. The company also noted that over-the-counter birth control pills are already sold in other countries.
But FDA officials noted that other countries don't typically treat over-the-counter drugs the same way as the United States.
In other countries, in addition to those sold with and without prescription, there is usually a third category: those dispensed by the pharmacist. Although a person in another country may not have to get a prescription, they may have to talk to a pharmacist who may or may not dispense the medication.
