Officials in the United States have approved the first over-the-counter birth control pill, allowing American women and girls to purchase contraception in the same aisle as aspirin and eyedrops. The Food and Drug Administration approved Perrigo’s once-a-day Opill for sale without a prescription on Thursday, making it the first such drug to be moved out from behind the pharmacy counter. The tablet will not be available for purchase until early next year, and there will be no age limitations.
Hormone-based tablets have long been the most popular form of birth control in the United States, with tens of millions of women using them since the 1960s. Until now, they all required a prescription.
Over-the-counter medications are often less expensive than prescription medications
Medical societies and women’s health organizations have advocated for more access, citing the fact that an estimated 45% of the 6 million annual pregnancies in the United States are unwanted. Teens and adolescents, women of color, and those with low incomes face higher challenges in obtaining and picking up medicines.
Some of the difficulties may include paying for a doctor’s appointment, taking time off from work, and arranging child care.
“This is really a transformation in access to contraceptive care,” said Kelly Blanchard, president of Ibis Reproductive Health, a non-profit group that supported the approval. “Hopefully this will help people overcome those barriers that exist now.”
Ireland-based Perrigo did not reveal pricing. Over-the-counter medications are often less expensive than prescription medications, but they are not covered by insurance.
Many common medications, such as those used to treat pain, heartburn, and allergies, have become non-prescription in recent decades.
Perrigo filed years of study to the FDA to demonstrate that women could understand and follow the pill’s instructions. The medicine was approved on Thursday despite FDA scientists’ worries about the company’s data, including whether women with specific underlying medical issues would comprehend they shouldn’t take the drug.
The FDA’s decision exclusively applies to Opill
The FDA’s decision exclusively applies to Opill. It belongs to an older type of contraceptives known as minipills since they contain a single synthetic hormone and have fewer negative effects than more popular combination hormone pills.
However, campaigners for women’s health hope that the ruling would open the way for more over-the-counter birth control choices and, eventually, abortion pills to do the same.
However, the FDA’s decision has nothing to do with the continuing legal disputes over the abortion drug mifepristone. The investigations in Perrigo’s FDA application began years before the Supreme Court’s Roe v. Wade decision, which has upended abortion access in the United States.
With some states restricting women’s reproductive rights, the FDA has been under pressure from Democratic legislators, health groups, and medical professionals to make birth control more accessible. Opill’s application for over-the-counter status was supported by the American Medical Association and the major professional society for obstetricians and gynecologists.