The Approval Process For Over-The-Counter Birth Control Pills

Two drugmakers are working toward FDA approval for their over-the-counter birth control pills, but there are multiple steps in the process.
Posted at 8:18 PM, Jul 18, 2022

Birth control as accessible as ibuprofen — that’s the ask to the FDA.

Two drugmakers have been working with the Food and Drug Administration on over-the-counter birth control pills for years.

Paris-based HRA Pharma has submitted their application for their contraceptive, Opill, 

and Candace Health is also in the pre-application process for their drug, Zena.

If either are approved, they would be the first oral contraceptive in the U.S. available without a prescription.

Birth control pills contain hormones that can prevent pregnancy by stopping or reducing ovulation, thickening cervical mucus to stop sperm or thinning the lining of the uterus to stop an egg from attaching.

The two pills are formulated with different hormone combinations, but the science behind making sure they work and are safe is the same.

"The progestin only pills, which is what the recent application is for — the reason that this is the first pill that's going forth to be over the counter is because the progestin only pills, there are very few contraindications," said Dr. Kate White, associate professor and OB-GYN at Boston University School of Medicine. "So because this one has a broader safety profile and more people can take it, this is the first pill that's going to be available."

"It's also important to ensure that there's no issues around addictiveness with any medication that's over the counter, and the birth control pills have met all of their requirements in terms of the scientific evidence," said Dr. Raegan McDonald-Mosley, chief medical adviser at Contraceptive Access Initiative.

That includes the results of an actual use trial with thousands of patients. HRA Pharma has completed theirs. Candance is running through their own now.

"They sort of simulated what it would be like to have access to an over-the-counter pill, allow people to use it and make sure that they chose the pill appropriately," Dr. McDonald-Mosley said.

The review process should take about 10 months, meaning an official decision would come in 2023.