FDA Approves Non-Prescription Morning-After Pill

The Food and Drug Administration approves over-the-counter sales of the morning-after pill, called Plan B by its maker, to those 18 or older. The FDA's decision ends a contentious 3-year effort to make it available without a prescription. But women 17 and younger will have to obtain a doctor's prescription to get the pills.

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STEVE INSKEEP, host:

It's MORNING EDITION from NPR News. I'm Steve Inskeep.

RENEE MONTAGNE, host:

And I'm Renee Montagne, good morning. The Food and Drug Administration today approved over-the-counter sales of the morning after pill to those 18 and older. The FDA's decision ends a contentious three-year effort by the drug's manufacturer - as well as advocates of the pill - to make it available to both teenage girls and women without a prescription. However, the FDA will require girls 17 and younger to have a doctor's prescription to obtain the pills. Joining me on the line to talk about the decision is NPR's Julie Rovner. And Julie, why is the FDA allowing this drug to be sold without a prescription, but only to those over 18?

JULIE ROVNER reporting:

Well, they see this as a compromise. The official reason is that they are not convinced that it could be used as effectively by those younger than age 18. But I must add quickly, that was not the finding of either of the FDA's own advisory committees - which voted overwhelmingly to make it available over-the-counter to those of any age - nor its senior scientists who seem to coalesce around an age of either 16 or 17, that probably 16 and 17 year olds could use this safely without a doctor's prescription. This issue has, obviously, as you mentioned, it's been going on for three years. It has now plagued the confirmation - slowed the confirmation of three different FDA commissioners. And the latest FDA nominee suggested 18 at his confirmation hearing last month.

MONTAGNE: Now, critics have said that the FDA has stalled on this approval for political reasons. How political is this?

ROVNER: It's been extremely political. There's really sort of two different political issues here. One is that there's a small minority of anti-abortion activists who believe that this pill can act as a very early abortion. Now, the FDA does classify it as a contraceptive. The FDA officials said again this morning that they think that it acts primarily by stopping ovulation, although there is some thought that it could prevent a fertilized egg from being implanted. And there are those who consider that to be an abortion.

This is not the same as the abortion pill RU-486. But there is that small subset who does not approve of this pill in any case. Then there's sort a broader group who worries about the idea of teenage girls being able to get this pill - the morning after pill - easily will encourage them to have more unsafe sex. Now there have been several studies on this. There actually is no evidence that that's the case, but there is still some concern about teenagers having easier access to this.

MONTAGNE: So looking ahead, does this FDA decision mean that women over 18 can get the drug any time?

ROVNER: Well, yes and no. It means that they can skip a step, that women over 18 will no longer have to go to a doctor and get a prescription. But they'll still have to go to a pharmacy. This will only be available in pharmacies, and it will only be available - as they call it - behind the counter. So you're going to have the pharmacist for it, which means that you will only be able to get it when the pharmacy is open and there is a pharmacist on duty. So you're now assuming that you have a pharmacy that's open when you need it, that there's a pharmacist there, and that there's a pharmacist willing to sell it to you. Because there have been cases of pharmacists around the country - a small group, but still a significant number - who, again, have ethical problems thinking that this is a very early abortion and refusing to sell it at all.

MONTAGNE: And has the manufacturer said yet when it would start selling the drug as a nonprescription drug?

ROVNER: Yes, they very much hope to get it on shelves before the end of the year, possibly as early as November. They have to actually change the labeling before it can be made available without a prescription, and that's just going to take a little time to get it done and actually get it on the shelf.

MONTAGNE: NPR's Julie Rover, thanks very much.

ROVNER: You're very welcome.

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How Plan B Works

Emergency contraception is available in several forms. The most effective, according to the Association of Reproductive Health Professionals, are those that contain a single female hormone, progestin. Two progestin-only pills are sold in the United States: Plan B and Ovrette. Only Plan B is specifically marketed for use as emergency contraception, but either can be used.

The active ingredient in Plan B and Ovrette, progestin, is one of the hormones commonly found in standard birth-control pills. However, Plan B contains a higher dose of progestin than a standard birth-control pill.

Plan B comes in a two-dose package. One pill is taken 12 hours after the first. To get protection with Ovrette, 40 of the "minipills" must be taken to equal the dose of progestin found in Plan B. Whichever is chosen, the sooner you take the pills, the lower your odds of getting pregnant.

Plan B recommends that to obtain optimal efficacy, the first tablet should be taken as soon as possible within 72 hours of unprotected intercourse.

Another type of emergency contraception uses a combination of two female hormones: estrogen and progestin. Outside the United States, this combination is packaged for sale as emergency contraception.

In the United States, doctors must prescribe regular estrogen/progestin birth-control pills (only certain kinds work for emergency use) and instruct teens and adults on how to take them.

Use of this type of emergency contraception reduces the odds of getting pregnant by 75 percent. As the ARHP Web site Not-2-Late.com explains, this doesn't mean that 25 percent of women using estrogen/progestin combinations will become pregnant.

"Rather, if 100 women had unprotected intercourse once during the second or third week of their cycle, about eight would become pregnant," according to the site.

Following treatment with an estrogen/progestin combination, only two women would become pregnant. In other words, a 75 percent reduction in the odds of becoming pregnant.

One of the controversies that surrounds this topic is the way these pills work inside the body.

Opponents of abortion rights say that the pills sometimes work to prevent the implantation of a fertilized egg into the uterus. They consider this action to be the same as an abortion. This raises the issue of when a pregnancy actually starts.

The U.S. government and leading medical societies define pregnancy as beginning at implantation, not fertilization. Other contraceptives also work by preventing implantation of fertilized eggs, blocking fertilization or inhibiting ovulation.

Emergency contraceptives are not to be confused with the so-called "abortion pill," RU-486, sold under the brand name Mifeprex. Mifeprex can only be used after a pregnancy has been established.

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