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.
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.
Life-saving drugs cost thousands in the US. Can laws change that?
Prescription drugs are often priced higher in the U.S. than in other countries, but there is legislation that aims to cut costs.By AP
The science and safety behind newly popular weight loss drugs
Today’s weight loss drugs pull from the science of diabetes treatments. Those have been proven for years to have fewer and less serious side effects.By Patrick Sison / AP
Amazon launches $5-a-month unlimited prescriptions for Prime members
The retail giant’s RxPass has a prescription list that includes more than 50 common medications.By Mark Lennihan / AP
The history and traditions behind Groundhog Day
What are the grounded facts of this holiday?By Barry Reeger / AP
Drones are being tested to deliver AEDs to cardiac arrest emergencies
Sweden is one of the first places to develop an AED drone delivery program, and over the span of four months, they made 11 deliveries.By Scott Sonner / City of Flirtey via AP
This young author is on a mission to make crayons more diverse
In 2020, Bellen Woodard rolled out More Than Peach crayons, which feature a variety of skin tones.By Scripps News