FDA to consider OTC birth control application
HRA Pharma, a pharmaceutical company based in Paris, France, and a company of Perrigo, announced it has submitted an application to the U.S. Food and Drug Administration (FDA) for the first-ever over-the-counter birth control.
The application comes just weeks after the Supreme Court overturned Roe v. Wade, which guaranteed the right to abortion care in the U.S. for nearly 50 years. The high court also noted that it may reconsider law that guaranteed access to birth control in its majority opinion, meaning reproductive healthcare could become more challenging to access in the future.
Approving an OTC birth control would reverse that trend. 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, according to HRA Pharma. Several healthcare organizations, including the American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians, have previously expressed support for an OTC birth control to improve access and lower barriers to care.
HRA Pharma applied for an Rx-to-OTC switch for Opill, a progestin-only daily birth control pill that is also known as a mini pill or non-estrogen pill. If approved, the medicine would be the first OTC birth control in the U.S. accessible without a prescription.
"This historic application marks a groundbreaking moment in contraceptive access and reproductive equity in the U.S.," Frédérique Welgryn, chief strategic operations and innovation officer at HRA Pharma, said in a statement. "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."
Opill, which consists of 0.075 mg norgestrel, was approved by the FDA in 1973 and has been used by millions of women to prevent pregnancy since. The medication is intended to be used as a daily pill, and its nearly 50 years of use and scientific research have underscored its efficacy and safety. If approved, Opill would be the most effective OTC birth control on the market.
"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."
Amy joined TriMed Media as a Senior Writer for HealthExec after covering home care for three years. When not writing about all things healthcare, she fulfills her lifelong dream of becoming a pirate by sailing in regattas and enjoying rum. Fun fact: she sailed 333 miles across Lake Michigan in the Chicago Yacht Club "Race to Mackinac."