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FDA approves the first over-the-counter birth control pill, Opill

MARY LOUISE KELLY, HOST:

The Food and Drug Administration has approved the first over-the-counter birth control pill. The daily oral contraceptive is called Opill. And NPR pharmaceuticals correspondent Sydney Lupkin is here to tell us all about it. Hey there.

SYDNEY LUPKIN, BYLINE: Hello.

KELLY: All right. So what is this? What is Opill? Is it different from existing birth control pills?

LUPKIN: Yeah, so really the newest thing about this is that it will be available without a prescription - that is, without seeing a health care provider first. The drug substance itself was actually originally approved for prescription use 50 years ago, so it's pretty well understood. It's a once-daily pill with pretty standard birth control side effects - headaches, cramps, bloating, things like that. The big thing here is that making it available over the counter in drugstores and convenience stores and supermarkets should make it a lot more accessible.

KELLY: Right, which has taken on new significance in light of the changes in abortion laws that have happened over this last year, right?

LUPKIN: Right. So since Dobbs - the Dobbs decision overturned Roe v. Wade last year, some states have effectively made abortion illegal. So people who don't want to be pregnant need more options for prevention. This pill is aimed at reducing barriers to hormonal birth control for people who can't get to a doctor, are between medical appointments, are teens and may be unable to get access to reproductive health care. It's also more effective than other things available over the counter, like condoms. And that's why medical societies like the American Medical Association and the American Academy of Pediatrics are applauding the FDA. However, they say it doesn't replace the need for abortion as medical care.

KELLY: Is it safe? Any potential downsides to making birth control pills available over the counter?

LUPKIN: So the FDA convened its panel of outside experts to advise it on this approval back in May, and the panel voted unanimously in favor of approval, saying the benefits outweighed the risks. They said that the labeling alone was enough for people to be able to use Opill correctly without a doctor's help. It's also a progestin-only pill, sometimes called a minipill, because it doesn't have estrogen in it. Dr. Sarah Prager, a professor of obstetrics and gynecology at the University of Washington Medical School, says that makes it even safer than other birth controls.

SARAH PRAGER: The progestin-only pill has an extremely high safety profile, and virtually no one can have a health concern using a progestin-only pill.

LUPKIN: She added that studies show people can adequately determine whether they are good candidates for birth control by looking at the label like they would for Tylenol or ibuprofen. Of course, the onus is on the person taking the pill to make sure they get a new pack when they run out because skipping doses renders the pill less effective.

KELLY: Two practical questions, Sydney - when can people get it, and how much will it cost?

LUPKIN: So the drug-maker has not yet announced its price and says it will closer to when the drug actually launches, which will be early next year. Obviously, if the price is too high, people won't be able to afford it, and the fact that it's available without a prescription will be somewhat moot. So especially for people who don't have a lot of money to spare, price is so key to access. Some prescription drugs that have become over-the-counter products are still pretty expensive. The company has mentioned that it plans to launch a patient assistance program to help people who can't afford Opill, but those programs are notorious for being full of hoops for patients to jump through. Ultimately, the company is running a business and needs to make money, so we'll have to wait and see.

KELLY: OK. And I think you heard me - I heard you answer that first question, when people can get it - sounds like it launches early next year.

LUPKIN: That's right.

KELLY: Okey-doke. Thank you very much, Sydney.

LUPKIN: You bet.

KELLY: That is NPR pharmaceuticals correspondent Sydney Lupkin. Transcript provided by NPR, Copyright NPR.

NPR transcripts are created on a rush deadline by an NPR contractor. This text may not be in its final form and may be updated or revised in the future. Accuracy and availability may vary. The authoritative record of NPR’s programming is the audio record.

Sydney Lupkin is the pharmaceuticals correspondent for NPR.