Perrigo Company plc's oral contraceptive Opill® has been approved for over-the-counter (OTC) sale by U.S. Food and Drug Administration (FDA) advisory committees, according to a press release.
Perrigo announced that the FDA's Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee (ORUDAC) voted 17-0 with no abstentions that the benefits of making Opill®, a progestin-only daily oral contraceptive, outweigh the risks. While the joint committee's vote isn't binding, it will be considered by the FDA when making its final decision regarding OTC approval for Opill® later this year.
"Today's vote reflects the strong data showing that Opill® can be used safely and effectively over the counter," said Perrigo Global Vice President For Women's Health Frederique Welgryn. "FDA's approval of Opill® for over-the-counter use would address a key unmet need for contraceptive access, be a groundbreaking expansion for women's health nationwide and a step forward toward ensuring people can have improved access to contraception without unnecessary barriers."
OTC oral contraception has received support from major medical organizations such as the American College of Obstetricians and Gynecologists, the American Medical Association and the American Academy of Family Physicians. If approved, Opill® would be the first birth control pill available over the counter in the U.S.
According to AP News, the joint committee's positive vote was made amid criticism from FDA scientists regarding Perrigo's study of Opill® and concerns surrounding the reliability of the initial study.
“We have an application with many complicated issues and uncertainties, including questionable reliability,” said the FDA’s Dr. Pamela Horn.
Most modern U.S. birth control pills contain a combination of progestin and estrogen. However, Opill® is one of an older class of contraceptives that only contain progestin, and they generally have fewer side effects and health risks but can be made less effective if they're not taken at the same time daily.
While the FDA's decision will not apply to other birth control pills, advocates hope that the approval of Opill® will encourage other drugmakers to pursue OTC sales, similar to how birth control pills are available without a prescription in much of South America, Asia and Africa.
