HRA Pharma Submits FDA Application for First OTC Birth Control Pill

HRA Pharma has submitted an FDA application to allow the OTC sale of their progestin-only daily birth control pill, Opill. If this application is approved, this will be the first birth control pill sold OTC in the United States.  

The environment surrounding contraception in the US has been unsteady and disconcerting for many people considering the recent Supreme Court ruling, which overturned Roe v. Wade. More than ever, people who can bear children seek safe, stable, and effective birth control methods.  

The CDC states that, as of 2011, 45% of pregnancies are unplanned in the US. Furthermore, the risk of unplanned pregnancies disproportionately impacts marginalized communities, with people of color and lower socioeconomic status at higher risk.  

It is thought that a lack of access to birth control may contribute to this high rate of unplanned pregnancies. 

According to an investigation in the Journal of Women’s Health, 29% of participants had problems obtaining a prescription or refills for contraception. Furthermore, the study found that these issues were more common for women who lacked a degree, were uninsured, or primarily spoke Spanish.  

The HRA application follows multiple organizations, including the AMA and the American College of Obstetrics and Gynecology, requesting the FDA to approve the OTC sale of contraception to reduce barriers to birth control accessibility.  

“This historic application marks a groundbreaking moment in contraceptive access and reproductive equity,” stated Frédérique Welgryn, Chief Strategic Operations and Innovation Officer at HRA Pharma, in the press announcement.  

“More than 60 years ago, prescription birth control pills in the US 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,” he went on. 

Opill has been approved by the FDA since 1973 and has proven safe and effective. It is composed of 0.075 mg of norgestrel. According to the FDA, less than 5% of people taking Opill have experienced adverse reactions.  

The FDA states that Opill works by “thickening the cervical mucus to inhibit sperm penetration, lowering the midcycle LH and FSH peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium,” on the label information.  

“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 in the HRA 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.”