FDA to Decide If Birth Control Pills can be Sold Over-The-Counter

March 30, 2023

The Food and Drug Administration is set to meet in May to discuss whether to allow a certain birth control pill to be sold over-the-counter for the first time ever in the U.S.

The pill in question is Opill, manufactured by the French drugmaker HRA Pharma. The pharmaceutical company that owns HRA, Perrigo, applied to switch Opill from prescription-only to over-the-counter last July.

Opill is a progestin-only medication, also referred to as a “mini-pill.” Progestin is a synthetic hormone that mimics progesterone in the body. Oral contraceptive pills usually consist of the hormones estrogen and/or progestin and are taken once a day.

Two FDA advisory committees—the Nonprescription Drugs Advisory Committee and the Reproductive and Urologic Drugs Advisory Committee—were initially set to meet back in November. However, the schedule got pushed back due to what the FDA said was a need to “review additional information requested related to the Opill Rx-to-OTC switch.”

Approximately 45% of all pregnancies in the U.S. are unintended, according to the Centers for Disease Control and Prevention.

The CDC further notes that hormone-based pills are the most common form of birth control in this country.

The American Medical Association has called for allowing the over-the-counter sale of birth control pills, saying it could remove barriers and increase access to contraceptives, helping to prevent unwanted pregnancies.

PHOTO: Bruce Blaus

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