Breaking News

FDA Approves 'Abortion Pill' Use in U.S.

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

NATALIE ALLEN, CNN ANCHOR: Our top story: mifepristone, also known as RU-486. More than a decade after the so-called "abortion pill" first became available in Europe, the FDA today approved its use in the U.S., a market its developer shunned. Used in conjunction with another pill, mifepristone is said to be more than 90 percent effective in ending early pregnancies.

We have extensive coverage, beginning with CNN medical correspondent Rhonda Rowland.

(BEGIN VIDEOTAPE)

RHONDA ROWLAND, CNN MEDICAL CORRESPONDENT (voice-over): Most people know it as the French abortion pill, RU-486. Its generic name is mifepristone. Now, with approval from the U.S. Food and Drug Administration, it will be marketed to American as Mifeprex.

GLORIA FELDT, PLANNED PARENTHOOD: Mifepristone, or the early option pill, is as significant a technological advance for women's health as the birth control pill was 40 years ago.

ROWLAND: The FDA gave mifepristone conditional approval in 1996, indicating the drug was safe and effective in inducing an abortion early in pregnancy. Final approval would come once a manufacturer was found and fulfilled criteria for labeling and manufacturing. The European pharmaceutical company Roussel Uclaf developed RU-486 but refused to market it in the U.S. because of abortion politics.

The patent on the drug was eventually given to Danco Laboratories, a new women's pharmaceutical company which will market and distribute Mifeprex. The identity of the actual manufacturers has not been released. Family planning experts say Mifeprex won't replace surgical abortion, but offer another option.

STANLEY HENSHAW, ALAN GUTTMACHER INSTITUTE: It helps women in the sense that, in some cases, they can end their pregnancies much earlier. Nowadays, with sensitive pregnancy tests, some women know they're pregnant even before they miss their period.

ROWLAND: Studies show Mifeprex is 92 percent effective in causing an abortion in the first seven weeks of pregnancy. Following extensive counseling, physical exam, pregnancy test and ultrasound to date the pregnancy, the woman take Mifeprex in a doctor's office or clinic. After two days. she returns and takes the drug misoprostol, a prostaglandin already FDA approved as an ulcer treatment.

After that addition of misoprostol, a hormone-triggering drug, most women will complete the abortion in the next six hours. In a small percentage of women, it can take up to a week to complete. Side effects include uterine cramping, heavy bleeding, nausea and fatigue. If the drug abortion fails, the women must have a standard, surgical abortion.

FELDT: 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: Mifepristone is already available to women in France, Great Britain and Sweden. In France, about half the women choosing to terminate a pregnancy choose medical abortion. The other half choose surgery. In the United States, it's expected that the cost of terminating a pregnancy with Mifeprex will be similar to the cost of a surgical abortion: about $300.

(END VIDEOTAPE)

ROWLAND: Mifepristone also has other medical uses. Preliminary studies suggest it could be helpful in treating breast and brain tumors, as well as uterine fibroids and endometriosis. So, now, Natalie, those studies looking at those other uses will probably continue.

ALLEN: We will have more about that in a moment as well. But you were telling me that the abortion pill is not necessarily safe for all women.

ROWLAND: That's right. According to the FDA, they've given us information that there are certain women who may not be candidates for this who decide to choose an abortion. These are women who are currently using an IUD, who have a tubal pregnancy, who have bleeding disorders or who have to use cortical steroids for a long period of time. Some people with asthma do use those particular medications. So it's important for a doctor to really check a woman's medical history.

ALLEN: And is this pill in itself a safer form of abortion than a surgical abortion for a woman?

ROWLAND: Well, it depends. Like with a surgical abortion, any time you do surgery there are risks with surgery. And there's risk with anesthesia, which you do need if you have a surgical abortion.

Here, again, with the drug abortion using these medications, you can have some very heavy bleeding. And in some of the women -- actually it's one out of 100 -- the bleeding may be severe enough that they would need surgery to actually stop that bleeding. So, again, neither procedure is without risk.

ALLEN: And as far as who can administer this pill, is it your typical OB/GYN who will now have access to it? ROWLAND: That's right. An OB/GYN could, but that doesn't mean that every physician, every OB/GYN may be willing to use this particular drug. Also, the FDA is requiring that whoever does administer it, whichever doctor chooses to, they have to be able to perform a surgical abortion in case the abortion with the drug fails, or they need to have a plan in place that they would have access or be near somebody who could, indeed, do that.

So it is a little complex. I mean, you do have to have some systems in place. And here again right now, even with surgical abortion, it's difficult to find providers. It may not differ that much even though we now have this medication.

ALLEN: All right, Rhonda Rowland, thank you.

And we'll continue now with Lou.

LOU WATERS, CNN ANCHOR: And as Rhonda mentioned, like countless other drugs, the abortion pill has other applications, and those other applications have saved lives.

We get one apparent case in point from CNN's Elizabeth Cohen.

(BEGIN VIDEOTAPE)

ELIZABETH COHEN, CNN MEDICAL CORRESPONDENT (voice-over): Every night for the past seven years, Doris Laird has taken the abortion pill.

DORIS LAIRD, MIFEPRISTONE USER: It saved my life and my sight.

COHEN: Mrs. Laird had a growth on her optic nerve.

LAIRD: I had a tumor the size of an orange in the middle of my head.

COHEN: Three times, surgeons removed as much of the tumor as they could, and three times it grew back. Then she started taking the abortion pill, properly called mifepristone.

LAIRD: The mifepristone has kept it from growing.

COHEN: Some 30 patients in the United States have special permission from the Food and Drug Administration to take mifepristone for a variety of illnesses, including cystic fibrosis, breast cancer and brain tumors.

(on camera): So how could mifepristone, a drug that induces abortion, also be used to treat brain tumors? It works because the same hormone, estrogen, helps tumors grow and helps fetuses grow. Mifepristone blocks estrogen, so in some cases tumors shrink.

(voice-over): Mrs. Laird hopes now that the drug is approved it'll be easier to get. Few doctors have been willing to go through all the red tape necessary to have it imported from France where it's made. DR. NETTLETON PAYNE, DORIS LAIRD'S PHYSICIAN: But it's available on a very limited supply through a very kind of circuitous route.

COHEN: Mrs. Laird's doctor, Nettleton Payne, wishes he knew more about the long-term side effects of mifepristone. For abortion, you take the drug for just one day. His patients take it for years.

PAYNE: Because of the politics surrounding the use of the drug, particularly in terms of abortion issues, the drug has never had a fully completed double-blind study.

COHEN: Dr. Payne says mifepristone doesn't work for everyone. Doris Laird is one of the lucky ones. Before mifepristone, her doctors told her the tumor might kill her, or at the very least incapacitate and blind her.

But now...

LAIRD: I jitterbugged at both my sons' weddings.

COHEN: Elizabeth Cohen, CNN, Atlanta.

(END VIDEOTAPE)

WATERS: Abortion has been a matter of intense debate in the United States for decades.

Frank Newport joins us now from the Gallup studio with a look at how public attitudes have or have not changed.

Frank, what have you got?

FRANK NEWPORT, GALLUP POLL EDITOR IN CHIEF: Well, Lou, it's not a clear-cut issue controversial as it is.

Let's do a little background for you. A little earlier this year, we actually asked the public about the abortion pill. Obviously there may be a different reaction now in future polls that's it's been officially been approved. But here's what we found earlier this year. Do you approve or disapprove of it being available to American women? Thirty-nine percent favor, 47 percent oppose. So. actually, at that point in time, slightly more opposition than favoring.

Now let's show you some of the more basic questions here. This is where we asked Americans to choose a label: Are you pro-choice? Are you pro-life? And you can see the lines have been very close. The red line is pro-choice. It was actually somewhat higher. The pro-life numbers came up, but in our last asking this year it's been about a 10-point difference, more Americans actually pro-choice than pro-life despite what we just showed you.

Now, here's the interesting point. There are not, despite some conventional wisdom, big differences between men and women on abortion. Notice that for men and women, the profiles look roughly the same in terms of the labels they choose. And also, I should say, on that abortion pill question, women were just slightly more likely to actually oppose it than men. So it's not like women totally favor it and men totally oppose it, men and women very, very close in their attitudes.

One final question to help set the stage for you -- and we've been asking this for a number of years -- three part choice: Should all abortions be legal in all circumstances? Less than a third say yes. Should they all be illegal in all circumstances? the classic pro-life position. You can see only 19 percent.

This is the story: About half of Americans, a little more, say some circumstances, yes, some no. And this is the environment that this abortion pill issue will play out in. Americans ambiguous, is the word I always use when I talk about abortion.

That's where the public stands. Natalie, back to you.

ALLEN: All right, we'll have no ambiguity with our next guest on this subject. Joining us to talk more about it, Patricia Ireland, president of the National Organization for Women; and Heather Cirmo with the Family Research Council.

Thank you both for joining us.

Ms. Cirmo, I'll start with you because so many abortion opponents have fought for over a decade to keep this day from happening in the United States, and here it is.

What's your reaction?

HEATHER CIRMO, FAMILY RESEARCH COUNCIL: Well, I think it's actually a setback for the women's movement.

You think about the potential physical side effects; but I want to focus on the emotional impact the abortion pill will have on women. And, for the first time, women, on their own, will have to deal with the remains of the aborted baby. And I know that it could be a -- it could look like a glob, but it's still a baby.

And she's going to have to deal with that in the privacy of her own home; and I think that we, at no time, at any point in history -- we need to be very concerned with what's happening with women, not only with what's happening with the children.

ALLEN: Is there anything more that abortion opponents can do at this time? Something I read said that many plan to pledge to continue to fight to keep this pill from becoming widely used.

CIRMO: Yes, I think pro-lifers are not going to cease in their efforts to communicate both love to the woman and to the child; and I think, at this point, those who really value life need to express their views at the polls and put people in place who really respect life.

And I want to make specific mention of the president, because a president has the authority to appoint a new FDA commissioner who could decide that RU-486 was put on a fast track and needs to be reconsidered. So that's a potential that we have in this election.

ALLEN: Patricia Ireland, would you react to that? And is this a setback for feminism?

PATRICIA IRELAND, N.O.W. PRESIDENT: Well, first of all, it's hardly been a fast track. It's -- RU-486 has been used around the world for 12 years now. It's been deemed safe and effective by the FDA for the last 7 years.

Compare it to how quickly Viagra was made available to men, which has much larger side effects -- indeed, has caused deaths in this country -- and I think that we understand it's been purely politics that has kept RU-486, mefipristone from women in this country; not only for abortion, but for fibroid tumors, for endometriosis -- and from all of us for breast cancer, ovarian cancer, HIV, AIDS, Cushing's Syndrome, Alzheimer's which, as I get older, I'm more and more interested in.

So I think that the abortion politics -- or the anti-abortion politics have been very difficult to get through. I would echo Heather only in the sense that the presidential election will have a huge impact.

One of my favorite buttons out in Los Angeles at the Democratic convention said: is the Supreme Court Stupid? We're five to four on the Supreme Court, not only abortion rights, but on so many other issues; and that's got to be a key election issue.

I don't think it's a setback. I think it's a great breakthrough when we have a safer, more effective and more private means of abortion that can be used in the first six or seven weeks of a pregnancy, much earlier than a surgical procedure.

CIRMO: But Natalie, this really, kind of, exposes the hypocrisy of the Clinton administration, who said they want to make abortion safe, legal and rare. This is not going to make abortion rare.

And I find it amazing that some people would rejoice that more abortions are going to take place. All we have today are legal abortions. We don't have safe abortions, we don't have rare abortions.

So it seems to me that there should be some outcry from the public that, you know, this is not the case. We haven't met our goals.

ALLEN: Is there the expectation this is going to mean more abortions? I was reading that it didn't actually increase the number of abortions in France when it became available.

IRELAND: That's correct; and only about 10 percent of the women in France have chosen this medical procedure. It's not for everyone, both for their health and for their emotions. It requires more than one trip to the doctors.

I'm disappointed that there have been restrictions put on it here. Part of our concern has been that this will move the abortion procedures or options into a physician's office and stop the targeting of physicians and their families in clinics.

Fewer and fewer doctors are available to provide abortions, fewer medical students are taking the training because they don't want to have to work in a bullet-proof vest and they don't want their families harassed and terrorized.

CIRMO: But there haven't even been that many restrictions. I mean, the Population Council, the very organization that is going to be marketing and manufacturing this drug, even recommended, when the FDA began to consider this approval of RU-486, that there be restrictions; and today we have only a few restrictions.

I don't think -- in fact, I think that there are too few restrictions. We might see quite a few lawsuits on our hands as a result of this. So, you know, it's not the pro-life community that was asking for restrictions, it was actually the pro-abortion lobby asking for restrictions.

IRELAND: Trying to get it approved under some circumstances.

ALLEN: We've seen some laws passed to try to restrict or limit abortions. How will the introduction of this pill affect, say, states' laws on this issue in the future?

IRELAND: It's going to remain to be seen. Most of people -- most lawyer-type people are arguing that the state laws of abortion will cover RU-486, will cover mefipristone for uses in abortion, and I suspect that that's true.

Still, perhaps, parental involvement, mandatory delays, anti- abortion counseling -- whatever kinds of restrictions have been imposed by the states will, presumably, still apply.

CIRMO: Like I said, Natalie, I agree with Patricia that I think it does remain to be seen. But I don't think it's fair for us to discount the emotional impact this will have on women, as all abortions do.

You know, you can put that to the side and say, emotional consequences, that's not really as important as physical; but you cannot dismiss that we are emotional beings. Especially women.

And we have to deal with the impact of this for the rest of our lives, and it's a real mistake to put that to the side when you're considering abortion of any shape, whether it's chemical or surgical.

ALLEN: We thank you both so much for talking with us on what is such a heated subject for so many people.

Patricia Ireland and Heather Cirmo, thank you so much.

And for more on the approval of the abortion pill and other health news, you can go to our Web site, CNN.com/health. It is produced with WebMD. TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com