FDA Approves First Non-Prescription Daily Oral Contraceptive
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The first daily oral contraceptive pill – Opill® (norgestrel) – has been approved for use by the U.S. Food and Drug Administration (FDA) without the need for a prescription, meaning it could soon be widely available at drugstores, grocery stores and online.
Over-the-counter oral contraceptives
Every year, nearly half of the 6.1 million pregnancies in the U.S. are unintended. Such unintended pregnancies are less likely to receive prenatal care and are at a higher risk of preterm delivery, possibly leading to negative maternal and newborn outcomes.
Now, the approval of Opill for use without a prescription by the FDA may help to reduce the number of unintended pregnancies and their associated risk of negative outcomes.
Opill – a progestin-only pill, also known as a mini pill or non-estrogen pill – was first approved for prescription use in 1973 and has been safely and effectively used to prevent pregnancy for almost 50 years. It uses progestin, a form of the hormone progesterone, to modify the menstrual cycle and bring about physical changes in the womb to prevent pregnancy. Unlike the combined contraceptive pill, it does not contain estrogen.
In July 2022, Opill’s manufacturer, Perrigo, filed an application to the FDA to switch Opill from prescription-only to non-prescription. This development follows in the footsteps of countries such as the U.K., which has recently approved similar progestin-only pills for over-the-counter purchase in pharmacies.
Until now, the U.S. was one of a minority of countries requiring a prescription. A study of data from 147 countries showed that 38% allow contraceptive pills to be informally available without a prescription, a further 24% have made them legally available without screening by a healthcare professional, while 8% of countries require health screening without a prescription.
In order for the FDA to approve Opill for non-prescription use, Perrigo had to show that consumers could use it safely and effectively with guidance from the drug labeling without assistance from healthcare professionals. Their studies showed that understanding of the drug facts label and instructions among consumers was high, demonstrating that they could safely use the drug as an over-the-counter product that is safe and effective when properly used. For example, progestin-only pills must be taken within the same three hours every day to be effective.
“Today’s approval marks the first time a non-prescription daily oral contraceptive will be an available option for millions of people in the United States,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available non-prescription contraceptive methods in preventing unintended pregnancy.”
Perrigo will now determine the timeline for the availability and price of non-prescription Opill, and approved formulations and dosages of other oral contraceptives will remain available by prescription only.
This article is a rework of a press release issued by the FDA. Material has been edited for length and content.