Pharma Focus Europe

Perrigo's HRA Pharma Submits Application to FDA for First-Ever OTC Birth Control Pill

Tuesday, July 12, 2022

Perrigo Company plc, a leading global provider of Consumer Self-Care Products, today 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.

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 Frédérique 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.

Major medical organizations, including the American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians, have expressed support for moving birth control pills OTC.

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 so4.

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.

"As a doctor, I am dedicated to empowering people to make decisions about pregnancy prevention. For many, a birth control pill may be the best option for them but requiring a prescription is an unnecessary obstacle that can put it out of reach," said obstetrician-gynecologist, Melissa J. Kottke, MD, MPH, MBA. "Removing the prescription requirement for a progestin-only birth control pill will be a historic advancement for pregnancy prevention and a remarkable achievement in community public health."

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