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FDA Approves 'Abortion Pill' for Sale in U.S.

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.

JEANNE MESERVE, CNN ANCHOR: We begin with a ruling released just moments ago. The Food and Drug Administration has given final approval for the so-called early abortion pill to be marketed in the United States. It's the one called RU-486 in France. Family planning experts call this a milestone comparable to the approval of the birth control pill 40 years ago.

CNN medical correspondent Rhonda Rowland has details.

(BEGIN VIDEOTAPE)

RHONDA ROWLAND, CNN MEDICAL CORRESPONDENT (voice-over): The FDA approval gives a woman another choice if she decides to end a pregnancy early.

GLORIA FELDT, PLANNED PARENTHOOD: It will enable them to choose, if they choose to terminate a pregnancy, to do that earlier, to do it without surgery. And for many women, that is a very positive thing.

ROWLAND: The new so-called "abortion pill" will be marketed in the United States as Mifeprex. It's generic name is mifepristone. An abortion with medications involves several steps. The woman takes mifepristone in a physician's office or clinic. Two days later, she returns to take a second drug, a hormone-inducing drug like misoprostol, which is already FDA approved.

DR. MITCHELL CREININ, UNIVERSITY OF PITTSBURGH: Mifepristone is not a magic abortion pill by itself. It's part of a treatment regimen. The second medication is just as important.

ROWLAND: In the United States, the combination of mifepristone and misoprostol has been studied in over 2,000 women.

CREININ: And what we did find was that for women that were less than seven weeks pregnant, that the medications were about 92 percent effective at causing a complete abortion very safely.

ROWLAND: A woman who participated in a study of mifepristone says the side effects were minimal.

UNIDENTIFIED FEMALE: And you had minor cramping with it, but it was over. Once it started, it was over quick.

ROWLAND: Her abortion was completed three hours after taking the second medication at home, though in some women the process can take up to a week and involve heavy bleeding and cramping.

UNIDENTIFIED FEMALE: This is -- I hate to use the word easy, but it's an OK thing if you make the decision and this is how you want to have it.

ROWLAND: Although surveys suggest more physicians would be willing to offer medical abortions than surgical abortions, access to the new drug is a concern.

CREININ: But right now, there's lots of laws in many states that restrict abortion practice, that restrict the practice of medicine to allow a clinician or a physician to provide abortion services. Medical abortion is not going to be any different.

ROWLAND: The cost of an abortion with the newly-approved drug is expected to be similar to a surgical abortion: about $300.

(END VIDEOTAPE)

ROWLAND: Now that Mifeprex is approved by the U.S. Food and Drug Administration, it will take about a month before it is available in physicians' offices and clinics -- Jeanne.

MESERVE: Rhonda, why has it taken so long for the FDA to give this drug approval?

ROWLAND: Well, one situation, first of all, to just backtrack a little bit, it was four years ago, 1996, when the FDA gave the drug conditional approval. That is, they recognized that it was safe and effective, but it could not be put on the market until a manufacturer was found. That obviously is a major situation there. You need to have somebody who's willing to sell the drug in the United States.

So in the last four years, there has been a search on to find a willing manufacturer. There was one, and then this particular manufacturer backed out, and then they went and they found another one, and we still don't even know who that manufacturer is.

So that's been a lot of the problem, finding somebody who was willing to manufacture it, and then they also have to meet certain criteria for labelling and how the drug would be used here in the United States, Jeanne.

MESERVE: Rhonda, why did they have a problem finding a manufacturer? Is it just that controversial?

ROWLAND: That's right. It's that controversial. It's because of the abortion politics in the United States. In fact, the Roussel Uclaf, the manufacturer who originally made this drug in France, refused to sell it in the United States. So what they did do is give the patent to the U.S. Population Council, and this is a nonprofit research group here in the United States. And then they have tried to look for somebody who is willing to manufacturer it. So, yes, it has been a long road, mostly for that reason -- Jeanne.

MESERVE: How will women get this drug? Through their doctors, through a pharmacy?

ROWLAND: They will definitely have to go to see a physician or go to, say, a Planned Parenthood clinic. They will not be able to get it from a pharmacy. It will require three visits to a doctor. Again, the first visit is to get the mifepristone, a woman returns two days later to take a second drug, misoprostol, and then she returns yet a third time within the next two weeks to make sure that the abortion is indeed completed. If it is not, she would have to go on to have a surgical abortion.

MESERVE: Rhonda, this does not mean the end of surgical abortions, does it?

ROWLAND: Absolutely not. And right now we don't have any idea the percentage of women who would perhaps choose this particular option. We do know that, in France, where the drug has been available for about 10 years, about half the women choosing abortion choose this option. That is, they use the drugs. We don't know what the attitudes will be of American women, so we'll have to wait and see.

MESERVE: Rhonda Rowland, thank you.

Anti-abortion rights organizations are not happy with today's developments.

Joining us now on the telephone, Heather Cirmo of the Family Research Council. She joins us from Washington on the phone.

First, give me your reaction to today's ruling by the FDA?

HEATHER CIRMO, FAMILY RESEARCH COUNCIL: Well, we think it's a very sad day. It's definitely a sad day for children who are in utero, as well as for women, though. This drug, I think, is going to be sold to women as a very attractive alternative to a surgical abortion. They can take it supposedly in the privacy of their own home, or at least they can have the abortion in the privacy of their own home.

But little has been said about how this really affects women, and this is a loneliness that I think that they've never experienced before when they've had an abortion. With surgical abortions, you go in and you have a surgery performed. And although the surgery can be traumatic, the abortionist is the one who deals with the remains of the child. But in this case, a woman has to face that, and I think we really need to consider the woman as well as the child.

MESERVE: Is it your fear that this will increase the number of abortions?

CIRMO: I do, yes. And it will be harder to reach those women who are considering an abortion. And, you know, pro-lifers are not -- they really have a genuine interest in both the woman and the child and they want to be able to communicate the options to the woman. And, unfortunately, with the approval of RU-486, this really seems like the woman has a one, easy option, which is to get rid of the child quickly. MESERVE: Where do organizations like yours go now? What do you do next?

CIRMO: Well, I think it's very important for people to -- people who do value life to go to the polls this November and vote for people who respect life. You know, the next president has the potential of putting an FDA commissioner who does respect life in place. And this person can review the approval process for RU-486 and can perhaps even say, you know, this was put on the market too quickly. We're going to review it again. So this is not a done deal, and the debate continues.

MESERVE: Heather Cirmo, Family Research Council, thanks for joining us -- Frank.

FRANK SESNO, CNN ANCHOR: Well, many feminist groups are hailing the development today. We want to tell you that, 2:00 Eastern time in New York, Planned Parenthood will be holding a news conference. CNN plans to bring that to you live.

And joining us here in Washington now is Eleanor Smeal of the Feminist Majority Foundation.

Thanks very much for coming in. Your reaction to this? You heard Heather Cirmo a moment ago.

ELEANOR SMEAL, FEMINIST MAJORITY FOUNDATION: Oh, I'm just thrilled. It's a total victory for women, and it's a breakthrough. It's a breakthrough for women's healthy. It shows that politics was trumped by science and by medicine, and that, basically, women's health has come first, and that's very, very important.

SESNO: Ms. Smeal, aren't you at all concerned, though, that the availability of this drug effectively lowers the threshold for abortions and may increase that number?

SMEAL: No, I'm not. There's so much experience with this. It's been -- throughout Europe there's over 12 countries that now have experience. Essentially what it will do is probably make it more early. I mean, for many women now, they can go immediately get a pregnancy test. In essence, it will probably do, eventually, about 50 percent of early abortions. It will give an option we don't have, a pill method that is very, very safe and effective.

We have a pill method, but this is a preferable pill method. And basically, then we can go on to test its cancer-fighting components, because, basically, because of this -- the anti-abortion politics and their threats, this drug has not been tested as an antiprogestin that can fight tumors that are dependent on progestin. And such tumors could be ovarian tumors, they can be breast cancer tumors, they could be uterine tumors, fibroids.

For example, fibroid tumors right now cause half of all hysterectomies in the country, and there's much indication that this would naturally -- this would reduce those tumors 50 percent and make the hysterectomy not necessary. So this could be a very, very big breakthrough. What this means is those clinical trials can go fast -- go forward now with more speed and more people having access to the drug. So it's a breakthrough for women's health: first for early abortion, and then possibly to fight other very serious illnesses.

SESNO: Eleanor Smeal, thanks very much. That will have to be the last word for now but certainly not in this debate. The drug approved today, but certainly the commentary and the thoughts, opinions still to come.

As we mentioned to you earlier, Planned Parenthood holding a news conference at 2:00 p.m. this afternoon in New York and CNN plans to take that live.

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