US approves first over-the-counter birth control pill
July 13, 2023
US regulators on Thursday approved the nation's first over-the-counter birth control pill.
The Food and Drug Administration said it cleared Perrigo's once-a-day Opill to be sold without a prescription.
The medication, Opill, will become available in pharmacies and supermarkets as well as online early next year, the manufacturer Perrigo said in a statement.
There will be no age restrictions on sales.
"Today's approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States," said Patrizia Cavazzoni, director of the Food and Drug Administration's Center for Drug Evaluation and Research.
This "may help reduce the number of unintended pregnancies and their potential negative impacts," the FDA statement added.
The US joins the list of countries that allow OTC
There are already a number of countries that have made the birth control pill available over the counter. However, in Germany, one needs a prescription to get a pill.
The move comes after states across the country restricted abortion rights following the Supreme Court's decision to overturn Roe v. Wade.
Roe v. Wade, a landmark 1973 judgement, established a federal right to terminate a pregnancy.
However, the studies in Perrigo's FDA application began years before the Supreme Court's reversal.
Thursday's approval came despite some concerns by FDA scientists raising concerns about whether women with certain underlying medical conditions would understand they shouldn't take the drug.
What is an Opill?
FDA's approval applies only to Opill, which is referred to as minipills.
It's an older class of contraceptives that contain a single synthetic hormone and generally carry fewer side effects than more popular combination hormone pills.
The pill was first approved in the U.S. five decades ago but hasn't been marketed here since 2005.
According to the FDA, common side effects of the pill include bleeding, headaches, dizziness, nausea and cramps.
Hormone-based pills have long been the most common form of birth control in the US, since the 1960's. Until now, all of them required a prescription.
Wider access to pills has been pushed by medical societies and women's health groups, noting that an estimated 45% of the 6 million pregnancies in the US are unintended.
ara/wd (AP, AFP)