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A company is seeking FDA approval for the 1st nonprescription birth control

AILSA CHANG, HOST:

A Paris-based drug company is seeking approval from the U.S. Food and Drug Administration for an over-the-counter birth control pill. If approved, it would be the first oral contraceptive available in the U.S. without a prescription. For more details on this, we're joined now by NPR's Allison Aubrey. Hey, Allison.

ALLISON AUBREY, BYLINE: Hey, Ailsa. Good to be here.

CHANG: Good to have you. OK, so, I mean, birth control pills have been on the market for - what? - 60 years now? They've always required a prescription. Just tell us why that might change now.

AUBREY: You know, the argument in favor of over-the-counter birth control is that it would help reduce barriers to contraception access. Survey research has shown that as many as 30% of women of childbearing age report a problem obtaining a birth control prescription or getting refills. The reasons people give vary. Some report not having a regular doctor, challenges getting an appointment or just being hesitant to go. I spoke to Dr. Jenny Villavicencio at the American College of Obstetricians and Gynecologists, who says logistics can be an obstacle, too.

JENNY VILLAVICENCIO: Taking time off work, getting child care, driving, parking, all of those things, then going to the pharmacy to pick up your prescription. It also incurs financial costs, particularly if you are under-insured or uninsured. And so those are just some of the barriers that exist with contraception, which we know is safe. And the science and the data has for a while shown that birth control is very safe to be offered over-the-counter and doesn't need a prescription.

AUBREY: Her group includes about 60,000 obstetrician-gynecologists. They've been on the record in support of over-the-counter birth control going back to 2012. And now, given the uncertainty over reproductive rights after the overturning of Roe, there's a heightened sense of urgency, Ailsa, to address these barriers, because reliable contraception is so important.

CHANG: So much more important these days. OK, so, I mean, how new of an idea is this, though, to make the pill available in the U.S. without a prescription?

AUBREY: Not really new. I mean, this has been in the works for years. A coalition called Free the Pill, which includes advocates, researchers, health care providers, has really been building the case going back to 2004. They have helped to lay the groundwork and kind of build the evidence base to support an FDA application. I spoke to the group's project director, Victoria Nichols, who explains the company that has submitted the application, HRA Pharma, must meet a whole bunch of FDA criteria to get over-the-counter approval.

VICTORIA NICHOLS: A person has to be able to take the medications as intended without a doctor's explanation. That's something that the pharmaceutical company has to prove through their data and their research. We believe that these pills are safe and effective and that people should be able to follow the simple instructions. You take a birth control pill once every day.

AUBREY: Dozens of countries around the globe have over-the-counter birth control, Ailsa, including Mexico, a bunch of Latin American and European countries. Last year, HRA Pharma, the company seeking FDA approval, got a license to bring a non-prescription contraceptive pill to the U.K., too.

CHANG: So what do you think the timing on this will be? Like, when would the FDA decide whether to approve this over-the-counter birth control pill?

AUBREY: Well, people watching this closely estimate the process could take about 10 months. The agency could ask a group of advisers to review the evidence, so sometime in 2023. You know, strategically, the company is seeking approval for what's called a minipill, which does not contain estrogen. And this makes it lower risk, since estrogen in the pill is linked to blood clot risks, which has always been something that doctors screen for when they prescribe the pill. So this progestin-only pill can be slightly less effective - 91% with typical use. But since it does not carry the same risks, doctors tell me it makes sense as a potential first over-the-counter option here.

CHANG: So exciting. That is NPR's Allison Aubrey. Thank you, Allison.

AUBREY: Thank you. Transcript provided by NPR, Copyright NPR.

Allison Aubrey is a correspondent for NPR News, where her stories can be heard on Morning Edition and All Things Considered. She's also a contributor to the PBS NewsHour and is one of the hosts of NPR's Life Kit.