The Food and Drug Administration (FDA) has granted approval for the over-the-counter distribution of Opill, an oral birth control pill that was previously only available with a prescription.
This landmark decision makes Opill the first oral contraceptive pill to be accessible without a prescription in the United States.
Dr. Patrizia Cavazzoni, Director of the FDA's Center for Drug Evaluation and Research, expressed the significance of this approval in a statement, saying, "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.
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."
Opill was initially approved by the FDA for prescription distribution in 1973. The FDA clarified that other formulations and dosages of oral contraceptives will remain available by prescription only.
It is important to note that Opill does come with a range of known side effects, including irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps, or bloating. The FDA justified the decision to make this product available over the counter by stating, "For approval of a product for use in the nonprescription setting, the FDA requires that the applicant demonstrate that the product can be used by consumers safely and effectively, relying only on the nonprescription drug labeling without any assistance from a health care professional."
According to the FDA, studies have shown that consumers have a high level of understanding of the information provided on the Opill Drug Facts label, including the instructions. Based on this data, the FDA concluded that over-the-counter approval was warranted.
Perrigo, the manufacturer of Opill, released a statement applauding the FDA's decision, calling it a "giant leap for women's empowerment."
It is worth noting that the FDA's decision may have been influenced, at least in part, by a June executive order issued by President Joe Biden. The order directed federal agencies to explore new measures to enhance access to affordable over-the-counter contraception.
This approval of over-the-counter distribution for Opill represents a significant step forward in providing accessible and effective birth control options for individuals in the United States.
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