FDA Advisory Panel Favors Over-the-Counter Birth Control Pill: Opill
A Joint FDA advisory committee vote favored the over-the-counter sale of Opill, a female birth control pill. If enforced, this vote would widen access to contraceptive care.
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- Echoing the voices of multiple major healthcare organizations and public health leaders, a joint FDA advisory panel favored making a birth control pill available over the counter (OTC). FDA leaders gathered a combined advisory board from the Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee (ORUDAC) to discuss making Opill, a progestin-only birth control pill manufactured by Perrigo, available OTC.
After two days of meetings and discussions, each of the 17 advisory panel members voted in favor of widening access to this contraceptive. Initially approved in 1973, this contraception is a daily dose of 0.075 mg of norgestrel, which has proven effective at preventing pregnancy.
"Today's vote to recommend a switch of Opill to OTC is a new, groundbreaking chapter in reproductive health. Perrigo is proud to lead the way in making contraception more accessible to women in the US," said Perrigo President and Chief Executive Officer Murray S. Kessler in the press release. "We are motivated by the millions of people who need easy access to safe and effective contraception. Today's outcome reflects Perrigo's steadfast commitment to women and people, and their health."
According to a Perrigo press release, the organization has spent eight years analyzing the efficacy and safety of Opill as an OTC option through its Opill OTC development program. The process included label comprehension studies and an additional trial that confirmed that patients could use the medication appropriately based on the label.
The trial, Adherence with Continuous Dose Oral Contraceptive: Evaluation of Self Selection and Use (ACCESS), found that OTC use and adherence to Opill did not vary significantly from prescription use and compliance.
Considering the current political climate surrounding access to reproductive care, approving the OTC sale of birth control pills would bolster access to care, providing an additional tool for pregnancy prevention and allowing individuals who can get pregnant more bodily autonomy.
"Today's vote reflects the strong data showing that Opill can be used safely and effectively over the counter," said Frederique Welgryn, Perrigo Global Vice President for Women's Health, in the release. "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."
