The first over-the-counter birth control pill has received approval from American authorities, allowing American women and girls to purchase contraceptives in the same aisle as aspirin and eyedrops.
The once-daily Opill from Perrigo is the first of its kind to be marketed outside of a pharmacy, according to a statement from the Food and Drug Administration on Thursday.
There will be no age limitations on sales, and the corporation won’t begin selling the pill until the beginning of next year.
Since the 1960s, tens of millions of women have taken hormone-based tablets, which have long been the most widely used birth control method in the U.S. Up to this point, each of them needed a prescription.
Given that an estimated 45% of the 6 million pregnancies that occur in the United States each year are unplanned, medical societies and women’s health organizations have fought for greater access.
Women of color, teenagers, and people with low incomes all report more difficulties receiving and picking up medicines.
Finding child care, getting time off work, and paying for health visits are a few of the difficulties that may arise. “This is really a transformation in access to contraceptive care,” said Kelly Blanchard, president of the nonprofit organization Ibis Reproductive Health, which backed the decision.
“Hopefully, this will assist people in overcoming the current obstacles.” Ireland-based Perrigo made no price declarations.
While typically far less expensive than prescription drugs, over-the-counter medications are not covered by insurance.
Several common medications, such as those for pain, heartburn, and allergies, have transitioned to being available without a prescription in recent years.
Years of research were presented to the FDA by Perrigo to demonstrate that women could comprehend and adhere to dosage guidelines.
The FDA scientists’ reservations regarding the company’s findings, including whether women with specific underlying medical issues would comprehend they shouldn’t take the medicine, were addressed in Thursday’s approval.
The FDA’s action exclusively concerns opioids. It belongs to an earlier kind of contraceptive known as “minipills,” which often have fewer adverse effects than more widely prescribed combination hormone pills because they only contain one synthetic hormone.
Advocates for women’s health, however, are hoping that the ruling will open the door for more over-the-counter birth control alternatives and, eventually, abortion pills.
However, the FDA’s decision is unrelated to the continuing legal disputes around the abortion drug mifepristone.
The research included in Perrigo’s FDA application was done years before Roe v. Wade was overturned by the Supreme Court, which has changed how Americans can access abortions nationwide.
The FDA has come under pressure from Democratic legislators, health groups, and medical professionals to make birth control more accessible as certain states restrict women’s reproductive rights.
The American Medical Association and the top obstetricians and gynecologists organizations supported Opill’s request for over-the-counter status.
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