In a groundbreaking move, the Food and Drug Administration (FDA) has given the green light to over-the-counter distribution of Opill, an oral birth control pill that has long been available by prescription.
This approval makes Opill the first oral contraceptive pill accessible without a prescription in the United States.
The approval of Opill represents a significant milestone, as it is the first time a nonprescription daily oral contraceptive will be available to millions of people in the United States.
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,” stated Dr. Patrizia Cavazzoni, Director of the FDA’s Center for Drug Evaluation and Research.
Opill, initially approved with a prescription in 1973, will join other oral contraceptives that remain available by prescription only, according to the FDA’s statement.
Safety and Consumer Understanding
To secure over-the-counter approval, the FDA requires products to be demonstrated as safe and effective for consumer use, relying solely on nonprescription drug labeling without assistance from healthcare professionals. Studies have shown that consumers have a high level of understanding of the information on the Opill Drug Facts label and its instructions, leading to the FDA’s conclusion that over-the-counter availability is warranted.
“Giant leap for women’s empowerment,” hailed Perrigo.
Opill manufacturer Perrigo hailed the FDA’s action as a “giant leap for women’s empowerment,” recognizing the increased accessibility and convenience the over-the-counter approval brings.
Executive Order and Accessible Contraception
President Joe Biden’s June executive order, which called for improved access to affordable over-the-counter contraception, may have influenced the FDA’s decision. This aligns with the administration’s commitment to ensuring reproductive health options for all Americans.