Regulator’s green light for nonprescription sales of a daily birth control pill comes as abortion restrictions tighten across the United States.
Regulators in the United States have approved the first over-the-counter birth control pill, paving the way for millions of women to buy the contraceptive without prescriptions for the first time in the country.
The Food and Drug Administration (FDA) said Thursday that it had cleared Perrigo’s once-a-day Opill to be sold without a prescription, making it the first such medication to be moved out from behind the pharmacy counter.
The company said it won’t start shipping the pill until early next year, and there will be no age restrictions on sales.
Opill was first approved for prescription use in 1973.
The approval was expected to reduce barriers for women in obtaining contraceptives at a time of increased focus on birth control since the Supreme Court last year overturned the constitutional right to terminate pregnancies by scrapping a landmark ruling in the 1973 Roe v Wade case.
Hormone-based pills have long been the most common form of birth control in the US. They have been used by tens of millions of women since the 1960s. Until now, all of them had required a prescription.
Medical societies and women’s health groups have pushed for wider access, noting that an estimated 45 percent of the 6 million annual pregnancies in the US are unintended. Teens and girls, women of colour and those with low incomes report greater hurdles in getting prescriptions and picking them up.
Some of the challenges can include paying for a doctor’s visit, getting time off from work and finding childcare.
“This is really a transformation in access to contraceptive care,” Kelly Blanchard, president of Ibis Reproductive Health, a nonprofit group that supported the approval told The Associated Press news agency. “Hopefully this will help people overcome those barriers that exist now.”
Ireland-based Perrigo did not announce a price. Over-the-counter medicines are generally much cheaper than prescriptions, but they aren’t covered by insurance.
Many common medications have made the switch to nonprescription status in recent decades, including drugs for pain, heartburn and allergies.
Perrigo submitted years of research to the FDA to show that women could understand and follow instructions for using the pill. Thursday’s approval came despite some concerns by FDA scientists about the company’s results, including whether women with certain underlying medical conditions would understand they should not take the drug.
Studies have shown that a high proportion of consumers understood the label instructions for using the drug, supporting their ability to properly use the drug when it is available as an over-the-counter product, the FDA said.
The FDA’s action applies only to Opill. It’s in an older class of contraceptives, sometimes called minipills, that contain a single synthetic hormone and generally carry fewer side effects than more popular combination hormone pills.
But women’s health advocates hope the decision will pave the way for more over-the-counter birth control options and, eventually, for abortion pills to do the same.
That said, the FDA’s decision has no relation to the ongoing court battles over the abortion pill mifepristone. Anti-abortion groups have been trying to limit access to the pill, which induces abortions.
The studies in Perrigo’s FDA application began years before the Supreme Court’s reversal of Roe v Wade in June 2022, which has upended abortion access across the US with 13 of the 50 states banning abortion, according to the Guttmacher Institute, and half a dozen other states imposing sharp restrictions on the procedure.
