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"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 U.S.," said Perrigo President and Chief Executive Officer Murray S. Kessler . "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."
Opill ® consists of 0.075 mg norgestrel, which has been used to prevent pregnancy in millions of women in the U.S. since it was approved by the FDA in 1973. Nearly 50 years of use and scientific evidence show that progestin-only pills such as Opill ® are effective at preventing pregnancy and are safe for most women to use.
The Opill ® OTC development program, conducted over the last eight years, included several Label Comprehension studies (LCS) that demonstrated consumers could understand the OTC label, and an actual use trial, ACCESS ( A dherence with C ontinuous Dose Oral C ontraceptive: E valuation of S elf- S election and Use), which showed that consumers could use Opill ® correctly based on the label, and follow the dosing instructions. Notably, adherence in the ACCESS study, taking the pill daily, was no different from published data on oral contraception adherence in the prescription setting (1) .
Additionally, Perrigo's data package included a published pregnancy impact model that estimated the number of unintended pregnancies Opill ® OTC could prevent, demonstrating the significant impact the switch to OTC could have on personal and public health in the United States . Overall, data demonstrate that consumers can use Opill ® safely and effectively as guided by the proposed labeling and highlight the benefits of removing the prescription barrier to oral contraception access.
"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. "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."
Nearly one-third of adult U.S. women who have ever tried to obtain a prescription or refill for a contraceptive pill, patch, or ring reported difficulties doing so. Removing the prescription requirement with Opill ® would improve access to a contraceptive method that is well tolerated and notably more effective at preventing pregnancy than all current methods available OTC (2) .
OTC oral contraception has support from major medical organizations including 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.
(1) Bosworth, 2018; Burnier, 2019; Potter, 1996; Fox, 2003; Hou, 2010. (2) Trussel et al, Contraceptive technology. 21st ed. 2018.
Perrigo Company plc (NYSE: PRGO ) is a leading provider of Consumer Self-Care Products and over-the-counter (OTC) health and wellness solutions that enhance individual well-being by empowering consumers to proactively prevent or treat conditions that can be self-managed. Visit Perrigo online at www.perrigo.com .
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SOURCE Perrigo Company plc