The US Food and Drug Administration on Thursday approved the birth control pill Opill to be available over-the-counter — the first nonprescription birth control pill in the United States.
“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,” Dr. Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”
This illustration provided by Perrigo in May, 2023, depicts proposed packaging for the company’s birth control medication Opill. Advisers to the Food and Drug Administration meet next week to review drugmaker Perrigo’s application to sell a decades-old pill over the counter. The two-day public meeting is one of the last steps before an FDA decision. (Perrigo via AP)
Opill is a “mini-pill” that uses only the hormone progestin.
Its manufacturer, Perrigo, called the FDA action a “milestone” and a “giant leap for women’s empowerment ” in a statement.
“Today’s approval is a groundbreaking expansion for women’s health in the U.S., and a significant milestone towards addressing a key unmet need for contraceptive access,” said Frederique Welgryn, Perrigo global vice president for women’s health.
Opill is expected to be available over-the-counter in stores by the end of March 2024.
At a news briefing on Thursday, Welgryn said Perrigo is “committed to ensuring that Opill is affordable and accessible to people who need it.” The suggested retail price will be communicated in the coming months, she said.
The FDA has faced pressure to allow Opill to go over-the-counter from lawmakers as well as health care providers.
Source: cnn.com
