WASHINGTON — A drug company is seeking U.S. approval for the first birth control pill that women could buy without a prescription.
The request from a French drugmaker on Monday sets up a high-stakes decision for the Food and Drug Administration.
"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," said Frédérique Welgryn, chief strategic operations and innovation officer at HRA Pharma.
If the FDA grants the company's request, women would be able to buy the pill from HRA Pharma over the counter, similar to common pain relievers.
According to The New York Times, Cadence Health is also planning to submit an application for its pills to be offered without a prescription.
Birth control pills are available without a prescription in many parts of the world.
HRA Pharma expects to receive a decision from the FDA within 10 months, according to The New York Times.