Perrigo announced that HRA Pharma, a Perrigo company, has submitted its application to the United States Food and Drug Administration (FDA) for the first-ever over-the-counter (OTC) birth control pill in the United States.
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The company has applied for an Rx-to-OTC switch for Opill, a progestin-only daily birth control pill (also referred to as a mini pill or non-estrogen pill).
If approved, this would be the first daily birth control pill available OTC without a prescription in the U.S.
"This historic application marks a groundbreaking moment in contraceptive access and reproductive equity in the U.S.," said FreÌdeÌrique Welgryn, Chief Strategic Operations and Innovation Officer at HRA Pharma.
"More than 60 years ago, prescription birth control pills in the U.S. empowered women to plan if and when they want to get pregnant. Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers."
Almost half of the more than 6.1 million pregnancies in the U.S. each year are unintended1. Access to a range of methods and ways to access contraception that meet people's needs will increase the likelihood of using effective birth control methods.
Opill consists of 0.075 mg norgestrel and has been used to prevent pregnancy in millions of women in the U.S. since it was FDA approved in 1973. Nearly fifty years of use and scientific evidence show that progestin-only pills like Opill are effective at preventing pregnancy and are safe 2,3 for most women to use.
As a daily regular contraceptive, Opill is to be used pre-conception to be effective at preventing pregnancy.
Nearly one-third of adult U.S. women who have ever tried to obtain a prescription or refill for 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. ■