FDA considers application for first-ever OTC oral contraceptive

HRA Pharma has submitted an application for what would become the first-ever over-the-counter birth control pill in the United States, if approved by the FDA.

“This historic application marks a groundbreaking moment in contraceptive access and reproductive equity,” Frédérique Welgryn, chief strategic operations and innovation officer at HRA Pharma, said in a press release.

The company applied for a prescription-to-OTC switch for Opill, a progestin-only daily birth control pill that consists of 0.075 mg norgestrel, according to the release, “and has been used to prevent pregnancy in millions of women in the U.S. since it was FDA approved in 1973.” Decades of use and scientific evidence demonstrates that progestin-only pills “are effective at preventing pregnancy and are safe for most women to use.”

About half of 6.1 million pregnancies in the U.S. each year are unintended, but one-third of women in the U.S. who have tried to get a prescription or refill for reproductive care “reported difficulties doing so,” the company said. Eliminating the requirement of a prescription could help expand access, according to Melissa J. Kottke, MD, MPH, MBA, an associate professor of OB/GYN at Emory University.

“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,” Kottke said in the release. “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."

Medical organizations have shown support for expanding access to oral contraceptives, including the AMA, which recently urged the FDA to make birth control available OTC.

“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” Welgryn said. “Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers.”