FDA advisers vote unanimously in favor of allowing 1st over-the-counter birth control pill
(NEW YORK) — Medical and scientific experts advising the Food and Drug Administration voted unanimously Wednesday in favor of allowing a birth control pill to be sold without a prescription.
The vote could sway the FDA, which ultimately needs to sign off. But if the FDA agrees, the progestin-only pill Opill could be on shelves this summer as the first over-the-counter pill sold in the U.S.
“The large body of evidence on the safety and effectiveness is very reassuring,” said Dr. Kathryn Curtis, a reproductive health expert with the Centers for Disease Control and Prevention, after voting in favor of easing access.
Opill, made by the French drugmaker HRA Pharma, which is owned by Perrigo, has been on the market since the FDA approved it in 1973. Known as a “mini pill,” the drug is considered by doctors to pose fewer risks than combination pills that rely on estrogen.
Still, the FDA has posed questions about whether women could screen themselves for risks. For example, certain breast cancer survivors shouldn’t take the drug and women shouldn’t ignore abnormal uterine bleeding while on the drug, which could be a sign of an unrelated medical problem like an ectopic pregnancy.
Another concern was whether there was enough data on how teens would use the pill and if young teens in particular – ages 11 to 14 – would read the labeling and take the medication correctly.
But after two days of discussion, panel members said they didn’t think those concerns were serious enough to insist that a person see a provider first — a hurdle that keeps many patients from preventing unwanted pregnancies. Of particular concern was the lack of health care access by people of color and those who struggle to find child care or transportation.
Dr. Eve Espey, an FDA adviser and chair of the Department of Obstetrics and Gynecology at the University of New Mexico, said an over-the-counter birth control pill is particularly needed in rural states like hers.
“I see it firsthand — people who face all of these barriers and who also experienced the maternal … mortality that goes along with unintended pregnancy,” Espy said.
“From my perspective, despite the FDA concerns about the study design and different interpretations of the studies, the overall very rare and unlikely harms are outweighed by the tremendous benefits of improved access without any restrictions,” she added.
Perrigo President and CEO Murray Kessler called the vote a “new, groundbreaking chapter in reproductive health,” while advocacy groups cheered the move as historic.
“It is past time for an over-the-counter birth control pill, which has the potential to advance reproductive justice and expand health equity,” Victoria Nichols, project director at Free the Pill, said.
Manufacturers of the drug haven’t said how much Opill will cost if sold without a prescription, although officials say the plan is to ensure it will be affordable.
ABC News’ Mary Kekatos contributed to this report.
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