FDA approves first over-the-counter birth control pill

The Food and Drug Administration has approved over-the-counter distribution of Opill, an oral birth control pill that has long been available for use with a prescription. With the approval, Opill becomes the first oral contraceptive pill available on an over-the-counter basis in the United States.

In a statement, Director of the FDA's Center for Drug Evaluation and Research Dr. Patrizia Cavazzoni said, "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 first was approved by the FDA for distribution with a prescription back in 1973. The FDA's statement made clear that "Other approved formulations and dosages of other oral contraceptives will remain available by prescription only."

Opill does have a number of known and widely recognized side effects, including "irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating." In explaining the decision to make this product available over the counter, the FDA explained, "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 there is "consumer understanding of information on the Opill Drug Facts label was high overall and that a high proportion of consumers understood the label instructions." In light of these facts, the FDA concluded that over-the-counter approval was merited.

A statement released by Opill manufacturer Perrigo called the FDA's action a "giant leap for women's empowerment."

The FDA's decision may have been prompted, in part, by a June executive order issued by President Joe Biden directing federal agencies to "consider new actions to improve access to affordable over-the-counter contraception."