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Breaking News

FDA Approves 'Abortion Pill'

Aired September 28, 2000 - 11:27 a.m. ET

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

DARYN KAGAN, CNN ANCHOR: And we have more news now on the FDA decision to approve what has been known as the Abortion Pill, Mifepristone. More now from our CNN medical reporter Ronald 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 women as Mifeprex.

UNIDENTIFIED FEMALE: Mifepristone, or the early option pill, is as significant a technological advance for women's health as the birth control year was 40 years ago.

ROWLAND: The FDA game Mifepristone conditional approval in 1996 indicating the drug was safe and effective in inducing an abortion early in pregnancy. Final approval would come one a manufacturer was found and fulfilled criteria for labeling and manufacturing.

The European pharmaceutical company Rousell-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 says Mifeprex won't replace surgical abortion but offer another option.

UNIDENTIFIED MALE: It helped 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 during the first seven weeks of pregnancy. Following extensive counseling, physical exam, pregnancy test, and ultrasound to date the pregnancy, the woman takes Mifeprex in a doctor's office or clinic. After two days, she returns and takes the drug Misoprostol, a prosteglandan (ph) already FDA approved as an ulcer treatment.

After the addition of Misoprostol, a hormone-triggering drug, most women will complete the abortion in 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 woman must have a standard surgical abortion.

UNIDENTIFIED FEMALE: 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 will Mifeprex will be similar to the cost of a surgical abortion: about $300.

(END VIDEOTAPE)

ROWLAND: According to Danco Laboratories, the women's pharmaceutical group that will be marketing the drug that will now be called Mifeprex, it should be on the market in about a month.

KAGAN: About a month, Still a couple of questions -- a bunch of questions on this, actually. Is this the kind of thing a woman can just go to a pharmacy and get these pills and take care of this by herself.

ROWLAND: Absolutely not. It will require three visits to a doctor. That's what the labeling will say. So you go to a physician, they date the pregnancy, make sure that it is within the first seven weeks. You take the Mifepristone. Then you return in two days to take.

KAGAN: You take it right in the doctor's office?

ROWLAND: In the doctor's office. That is right.

KAGAN: Just swallowing a pill.

ROWLAND: Actually it will be three pills that you swallow in the doctor's office. Then you go home. Two days later you're supposed to return to the doctor to take the second pill, Misoprostol. Here again, two pills that you would take. And then, within six hours, the bleeding should begin.

Then you are asked to return to the doctor for a third visit about 12 days later to make sure that the abortion is complete.

KAGAN: Now we have heard about the morning-after pill; is that what this is?

ROWLAND: No. Two different drugs here. Two different purposes. Again, Mifepristone is intended to end a pregnancy. The morning-after pill is used as a contraceptive. That is, you don't even know it you are pregnant, you would take that. So morning-after pill, Mifepristone, two different drugs.

KAGAN: Listening to your piece, it sounded like there was some kind of uncomfortable complications that could happen from this. It is not just as simple as taking a pill and your pregnancy is over. There is still some discomfort that could come with going through this process.

ROWLAND: That is right. There can be a lot of cramping. There can be nausea. There can be very heavy bleeding. In some women, the bleeding can continue up to 16 days afterwards. That's why women really have to be counseled to know what to expect. No, it is not just a pill, you take it and it is over with. This is something that some women do experience, like I said, for up to two weeks.

KAGAN: Is this the kind of thing -- if you find you are pregnant and want to end the pregnancy, you go to doctor, you would get to choose what kind of abortion you want to have? I want to take the Misopristone or I want to have a regular abortion. Not want to, or does the doctor tell you, you're a candidate for this, or you should do it this way?

ROWLAND: This is something that is giving a woman who chooses to end their pregnancy to have another option that they have a choice. So again, you can find out with a pregnancy test so early today when you are pregnant. I mean, right when you are pregnant you know. So you go to a doctor and it's your choice, if you want to have the surgical abortion, or if you would want to use this option.

KAGAN: Who is going to be able to use it?

ROWLAND: This would be available to any woman.

KAGAN: Any woman, OK, Rhonda Rowland stay with us. We will still talk about this a little bit more. We have another piece and Andria has more.

ANDRIA HALL, CNN ANCHOR: The question is: Are there other uses for Mifepristone?

Let's go to piece by Elizabeth Cohen now, who can explain some of that for us.

(BEGIN VIDEOTAPE)

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

UNIDENTIFIED FEMALE: It saved my life and my sight.

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

UNIDENTIFIED FEMALE: I had 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.

UNIDENTIFIED FEMALE: 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 Mifepristone for a variety of illnesses, including Cystic Fibrosis, breast cancer, and brain tumors.

(on camera): How could Mifepristone, a drug that induces abortion, also be used to treat brain tumors. It works because the same hormone, Estrogen, helps tumors grew 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 will 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 is made.

DR. NETTLETON PAYNE, NEUROLOGIST: But it's available on 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 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 that Mifepristone, doesn't work for everyone. Doris Laird is one of the lucky ones. Before Mifepristone, he doctors told that her the tumor might kill her, or at the very least, incapacitate and blind her.

But now...

UNIDENTIFIED FEMALE: I made it to both of my son's weddings.

COHEN: Elizabeth Cohen, CNN, Atlanta.

(END VIDEOTAPE)

HALL: What do Americans think about this so-called abortion pill and about abortion in general? Let's check in with Frank Newport, who has got the numbers for us -- Frank.

FRANK NEWPORT, GALLUP POLL EDITOR-IN-CHIEF: Indeed, we can do a review. Knowing this decision was coming up, we prepared some data to show you where Americans stand. We did ask about the abortion pill. We phrased it RU-486 at that time, although that is not the official name.

Here's what we found: Would you favor or oppose making it available in this country? Interestingly, you can see slightly more opposed than favored at that point. Although, generally speaking, there are mixed attitudes towards it. That is because, in general, Americans have mixed attitudes on abortion.

We will show you a trend, real quick, to just set the stage as we discussed the decision that came down here. Are you pro-choice or pro-life? Going back to 1996, very close. The pro-choice line is a little higher. You can see, now, it's about 50-40 percent. Basically, very mixed attitudes on that issue.

A lot of people, think this is a woman's issue. Not necessarily the case, our data consistently show women's attitudes, overall, on abortion, not much different than men's. You can see pro-choice, pro- life, there, between men and women, roughly the same numbers.

Finally, one other way of looking at abortion, just to help set the stage for you: Should abortion be illegal in all circumstances? Only 28 percent say yes. Classic pro-life position, illegal in all circumstances, only 19 percent say yes. The bulk of Americans, about 50 percent, are in that gray area. They want, occasionally, abortion available and not in all circumstances, and that's probably why we get, overall, those mixed reactions to the idea of the abortion pill being made available to American women.

That is the where the public stand as background. Back to you in Atlanta.

HALL: Frank, I am just curious. Did you do any studies at all on how people viewed the abortion pill versus the classic abortion, a surgical abortion?

NEWPORT: Yes, that would be a good question and we have not asked it to date, but we will put that down and maybe ask it in our next poll.

HALL: OK, remember who thought of it, now.

Frank Newport, live.

OK, let's go to Daryn now.

KAGAN: Good question, in fact, we have more questions about, actually, how this abortion pill works. We have made Rhonda Rowland stick around.

You have not be excused from the table just yet.

Now, we saw in your piece, and you explained to us how you take three pills over a number of days. But what is actually happening within a woman's body that terminates the pregnancy?

ROWLAND: Well, the first pill, the first set, we take the three of the mifepristone. What actually is happening there, is that this particular drug blocks progesterone. That is a hormone that a woman needs in order to sustain a pregnancy, so it's blocking that particular hormone. And again, a woman would go back, two days later, and take misoprostol. This is a prostoglandin (ph) This is a drug that actually brings on contractions.

So, you need both of these drugs together, in order for the abortion to take place. One is not enough. You need both of them.

KAGAN: Go ahead.

HALL: I just have a question about the psychological ramifications for women. Of course, going through a surgery of any kind is going to be traumatic. Did they do any studies at all, or talk to women over in Europe about how they dealt with it psychologically? Taking a pill, versus going through a surgery for abortion?

ROWLAND: Clearly, this option is not going to be for everyone, because if you have surgery, you go in, you have the procedure. It's over with. This is something that could take a matter of days. So, women need to be counseled to expect that. This may not be an option, again, for everyone.

However, they did do studies of women who were in studies of this drug, and they found that more than 90 percent of the women, would recommend this to another woman considering this particular choice, even if the drug option failed. That is, in a small number of women, they still have to go ahead and have a surgical abortion afterwards. Sometimes it does fail. Even in those women, they still would, most of them, would recommend this option.

HALL: So, it's almost like the trauma is different, but equally great for both procedures.

ROWLAND: Definitely, definitely.

KAGAN: What about -- this pill has been on hold for so long, here in the U.S. Do we have any idea the number of women would make use of it? How many people were looking to have this as an option here in the U.S.?

ROWLAND: We don't exactly know, but what we do know, is in France, where it has been on the market for many, many years, about half of the women who do choose an abortion, choose this particular option. They don't yet know what American attitudes will be, if it will be the same number. So, that is something that they will have to see.

HALL: In fact, the original maker of the pill over in France refused to promote it here in the U.S., because of the social implications and political implications. I believe I read that.

ROWLAND: That is right. Because of the abortion politics in the U.S., they would not sell it here. So what they did do, is give the patent rights to the U.S.-based population counsel. They're a research group and then they have the responsibility of developing it here in the United States and looking for a manufacturer. KAGAN: OK, Rhonda, again, we're going to ask you to stand by and don't leave us quite yet.

We have on the phone with us Gloria Felot, the head of Planned Parenthood, joining us on the phone.

Gloria, thanks for being with us.

GLORIA FELOT, PRES., PLANNED PARENTHOOD: Thank you.

KAGAN: What is your reaction to this news?

FELOT: This a great day. This an enormously important step forward for women, for reproductive health technology. It gives women a new early option. Those women, who have chosen to terminate their pregnancies, can now do so very early in pregnancy and without surgery. And it's, you know, it's been a long, and arduous scientific process. But, quite frankly, the political process has been even longer and more arduous. And I am so glad that the scientific process finally triumphed over the political process.

KAGAN: Gloria, right before this news broke, we, actually, were having a debate, a discussion and we did have right to life side on here and their point is: This makes it too easy, too easy for women to terminate a pregnancy.

GLORIA FELDT, PRESIDENT, PLANNED PARENTHOOD: Well, you know, I think anybody who says it makes it too easy to for women to terminate a pregnancy just have so little respect for women's intelligence and for women's consciences and for women's hearts.

The experience in France, by the way, is that the numbers of abortions and the percentages of abortion, of women who chose to have abortions, did not increase at all; and I don't anticipate that the numbers of abortions or the abortion rate will increase at all in the United States either.

It will simply give women another option; and women should have all medically, safe and appropriate options available to them. You know, our sisters in Europe have been able to exercise this choice for 12 years now. It's way past time for American women to have that same option, and I trust women to be able to make their own responsible choices.

KAGAN: Explain to us the practical side of this. How is Planned Parenthood going to make use of this drug?

FELDT: As soon as the product is actually available to us -- and we expect that that will be in about a month -- Planned Parenthood centers will begin offering this service, those that are prepared to do so.

We expect that 120 of our 850 health centers, nationwide, will begin offering mifepristone in about a month and that that number will increase to about 165 by the end of the first year and it will continue to grow. So we certainly intend to be doing everything we can do to make it available to American women. We've been training our doctors, our clinicians, our counselors, now, for the last several months and we are very prepared to provide the excellent quality of medical care that people depend upon Planned Parenthood for.

KAGAN: Gloria, up to this point the topic of abortion has been pretty quiet on the presidential election campaign, on that front.

Do you think that the approval of this drug is going to bring it back to the forefront?

FELDT: I am sure that it will.

I would expect that both candidates for president ought to have something to say about this; and I will look forward to hearing what they do have to say. I think it will help to sharpen the difference between the two on this issue.

KAGAN: Gloria Feldt, the president of Planned Parenthood, thanks for joining us on the phone so quickly.

Rhonda, we just, you know, heard from Gloria Feldt, Planned Parenthood; she said it will be in -- within a month, which is about the time frame that you were talking about -- about 100 or 160 of Planned Parenthood centers across the country.

But not 800. It's going to take time for this drug to have access -- for all women to have access to this drug.

ROWLAND: And that's like any kind of drug that's come out. It does take a little while to actually get out in the community. Training is required, so everybody knows how to actually administer this particular drug.

So whenever something new comes out, it does take a little while -- and that's also to get to physicians offices', that is, the physicians who would choose to actually make this available to their patients.

KAGAN: It does bring up the question of access; and there has been -- this has been a problem, especially, for women in rural areas -- getting access to doctors who perform abortions because, in a lot of places, it's been known that they're not welcome in those communities.

Will this spread the access of abortion and that choice to women in places where they haven't been able to get that?

ROWLAND: Well, you make a very important point. In fact, in the majority of counties in the United States, there are not physicians who are willing to perform surgical abortions.

KAGAN: Really, the majority of counties, they're not?

ROWLAND: That's right, the majority. And, in fact, in many states, abortion is restricted to a great extent; and doctors that we talked to, who are in favor of using this particular pill say, it will not really be any different once this pill comes out. It still is something that -- it will not necessarily be that a woman could go to any doctor to get this.

Again, it's going to be a doctor who is willing to and wants to make it available to their patients.

KAGAN: Because, as you pointed out, sometimes the pills don't do the whole procedure and the surgical procedure is needed to follow-up.

So you would have to go to a doctor that could perform both.

ROWLAND: That's right. I mean, you would want to be in an area where, if you do need that, that you would have access to that particular service.

HALL: Well, as you can imagine, the National Right to Life group has a very different perspective on this, and Laura Echevarria is on the telephone with us now.

Ma'am, this is not a great day for you, I'm sure.

LAURA ECHEVARRIA, NATIONAL RIGHT TO LIFE COMMITTEE: Well, actually, I think it's better to say that it's a sad day in America for unborn children, and certainly for the mothers of those children -- the mothers who take RU-486.

We know that there's some very serious side-effects associated with RU-486 and we were hoping that the FDA would take a serious look at the U.S. studies and the European studies and reject RU-486 because of that. But, certainly, we see it as a sad day.

HALL: Now, you say that you were hoping the FDA would take a serious look -- are implying that they didn't?

ECHEVARRIA: Well, this has been a political process. I heard what Gloria Feldt said just a minute ago, and I do agree with her on one thing: This has been a political process.

When Bill Clinton took office and when he -- when the Clinton- Gore administration first came in, he pretty much pushed the FDA, authorized them, asked them and prodded them to pursue the introduction of RU-486 into the United States; and it has been a political process.

It is something that this administration has wanted, and they have pushed this. So it has been politicized.

HALL: So, Ms. Echevarria, what is the National Right to Life organization planning to do in the political realm, considering we're in a presidential election; we're only about 39 days away from electing a new president who will take a definitive stand on this issue.

What are your plans now?

ECHEVARRIA: Well, certainly, if a pro-life president is elected that may, very well, mean that the FDA -- a different FDA head may seriously sit down and look at the scientific studies that have been done on RU-486. There is cause for concern and there is very good reason to go back and review RU-486 and the dangers associated with the drug.

We know than one woman in Iowa almost died during the U.S. trials, and if that can happen during the trials, then that certainly can happen if RU-486 is released into the U.S. marketplace.

HALL: Well, now that the FDA has approved the drug, are you planning to put together literature?

What is going to be your plan of attack it terms of educating women on where you stand, where your organization stands on this drug?

ECHEVARRIA: Well, it will be two-fold.

First, we want to make sure they understand the development of their child. When a woman realizes that she is pregnant and actually takes RU-486 in the early stages of the pregnancy, more than likely her baby's heart has already begun to beat. That begins at 18 to 22 days after conception takes place.

And at the outside end, as late as it can be taken, which is around seven weeks of pregnancy -- RU-486 can be taken then -- a woman, more than likely, at that point in time, we know that brain waves can be detected in the unborn child.

So that's information we want them to have; and, in addition, we want to make sure that they know the dangers associated with RU-486. So, certainly, we will step up our educational efforts so that women are fully aware of the dangers that are related to the use of this drug.

HALL: Laura Echevarria from the National Right to Life group, we thank you for joining us.

And we also know that mifepristone can be used for other reasons: to fight brain tumors and cystic fibrosis. So now, let's go to Daryn with more.

KAGAN: As we continue our conversation, we were just a little bit early -- when we had our earlier conversation with Olivia Gant and Eleanor Smeal, so we're rounding them up to talk about reaction to the news.

Eleanor Smeal, seated once again in our Washington bureau -- Eleanor, your reaction to the news that mifepristone has been approved?

ELEANOR SMEAL, PRES., FEMINIST MAJORITY FOUNDATION: I can't tell you, I'm so delighted. I've been working on this for 12 years. It is a major breakthrough for health for women. It's safe, it's effective. Those are scare tactics of the National Right to Life Committee.

Now the FDA has approved it. I think this is so major, not only for the women of the United States, but for the women of the world because this means that tests, now, will also begin on its other many beneficial uses. It's just a wonderful day.

KAGAN: If it's such a wonderful drug, why did it take so long?

SMEAL: Well, because of the anti-abortion politics. Let's be real.

They've used every scare tactic you could use. They have threatened manufacturers. There has been violence, as you know, at the clinics and they have made it so miserably hard. And to say that the FDA hasn't taken a look at it -- I mean, this has been before the FDA for years.

This has been -- it's 12 years in the making; and we finally have it here and it's been the most tested drug -- over 10,000 people here in the United States, thousands of people, literally hundreds of thousands around the world, have taken it. Women have taken it.

And those are scare tactics. The side effects have been very, very minimal.

KAGAN: Eleanor, speaking of time, do you have a little bit more time just to stay with us a bit?

SMEAL: Sure.

KAGAN: OK, we're going to have you stay there, we're going to look at this time frame, a 12-year time frame.

Our own Rhonda Rowland has put together the story of how this has gone through the approval process here in the U.S. Let's take a look.

(BEGIN VIDEOTAPE)

ROWLAND (voice-over): The road to this week's FDA action has been a long one for the drug. It's medical name is mifepristone.

Twenty years ago, a French company, Roussel-Uclaf, developed the drug, also known as RU-486. It was later made available to women in France, the United Kingdom and Sweden.

In 1993, the Clinton administration lifted a Bush administration ban that prevented American women from importing RU-486. Because of abortion politics, Rousel-Uclaf would not agree to distribute the drug in the United States. In 1994, it donated the patent rights to the population counsel so the non-profit family planning group could study it and find a willing manufacturer.

DR. MITCHELL CREINEN, UNIVERSITY OF PITTSBURGH: The studies in the United States were just a continuation of studies that had been done in Europe and didn't show much different than what we already knew, which was that mifepristone, combined with another medication, like misoprostol, is a safe and effective option for early abortion.

ROWLAND: Misoprostol, a hormone-inducing drug, is already FDA approved for the treatment of ulcers. In 1996, the food and drug administration issued an approvable letter for mifepristone that acknowledged the drug was safe and effective.

But the FDA withheld marketing approval until manufacturing and labeling information was provided -- a major glitch, since the population counsel has not yet found a company to make the drug.

In 1997, another delay for the pills' advocates. A manufacturer who agreed to produce mifepristone for American women, backed out. Since then, a new pharmaceutical company, Danco Laboratories, stepped in. Danco plans to market mifepristone, and while a manufacturer has been found, its name remains a secret.

Now that mifeprex has been FDA approved, it will be at least a month before it's on the market.

(END VIDEOTAPE)

ROWLAND: And they expect the cost to be about the same as what a surgical abortion costs, and that is about $350.

KAGAN: Getting back to this discussion of what it is and how you take these three pills, it is a combination of drugs. Some of those drugs have already been out there.

KAGAN: That is right. The second drug, misoprostol, that you take, say, two days after you take the mifepristone, that has already been on the market. That is FDA approved. It's out there for the treatment of ulcers. But Searle, the manufacture who makes it, has in recent months sent letters out to doctors reminding them that this drug is only approved for the treatment of ulcers, and that it can be dangerous to a developing fetus.

But again, once a drug is FDA approved, doctors have the freedom to use it off-label, that is a term, they can use for something else, another purpose, even though there is not that FDA approval for that purpose.

KAGAN: Well, isn't that kind of the unspoken story here. That, for years, doctors have been using these combinations of drugs to help women have their own abortion though pills, even though it has not been approved for those purposes.

ROWLAND: In two different ways. One is, again, to bring about an abortion and they are using the drug Methotrekate (ph). This is a drug out there approved for cancer. It is a chemotherapy agent. You can use that, along with misoprostol again to bring about an abortion, but it is not quite as effective as the mifepristone/misoprostol combination. So that it why it is not used to a great extent. Also the morning-after pill, which we do not want to get that confused with this, that is a combination with birth control pills, and you can use that the day after unprotected sex to prevent pregnancy. So again, off-label uses.

HALL: Do you think that women who have anticipated the approval of this drug had a misconception that it is just pop the pill and it is over with so they can put it behind them? They're going to be very surprised with this information that it is a process that you really do have to go to a doctor, that it's not a one-day deal, and that it may not work.

ROWLAND: Well, I think that there is a little confusion out there among the public, and that is the confusion with the abortion pill and with the morning-after pill. There are two, separate, types of drugs. And again, women will need to be educated about what the abortion pill is, and how it is used, and again what the process involves.

KAGAN: We still have our guest in Washington, Eleanor Smeal. Let's go ahead and bring her back in here.

Eleanor, as you were looking at that time line that Rhonda put together, did is remind you of what a long journey it has been?

SMEAL: Yes. I can't tell you. I have walked through this every day. And it has been very long. When manufacturers dropped out, there were threats. I mean, this has not been an easy course. But women have been determined. Our side has been determined. Danco Laboratories had to be set up for this. And they're now set up and we -- it's all go.

And you know, by the way, your screen said 92 percent effective. Actually, the latest studies have it between 96 and 97 percent effective. This is a very effective drug.

KAGAN: Looking to Rhonda, and that is the studies that you have cited.

ROWLAND: Yes, that is right, when the studies were done -- "New England Journal of Medicine" that were done about five, six years ago they showed about 92-95 percent effective. And they do believe that the effectiveness rate can go up, again, as everyone has experience with using these medications.

HALL: Ms. Smeal, what do you anticipate the political backlash to be now that the drug has been approved?

SMEAL: Well, we are worried of course, and we are going to remain very vigilant. We are worried that the Republican nominee has made anti-statements about mifepristone. So we are worried that politics could enter after the election, if in fact he were elected.

But frankly, I think what happened today is that medicine trumped politics, and I think that it's medicine and science here that is having the last word. I think that this is approved. I think it will stay approved, and I think, I am very excited, that we can now move forward with clinical trials for uterine tumors that progestin- dependent, and for ovarian cancer that is the type that is progestin- dependent.

This could have a very profound impact on certain types of tumors, as well as providing an early effective method of abortion at the embryonic stage, and I think that it's very important. Because at that early stage, it helps to reframe the abortion debate itself. Because the antis want to picture abortion in the 9th month in the 29th day. And this takes effect in the first 49 days of pregnancy, the very, very earliest of stages.

KAGAN: Eleanor Smear, I want to thank you for getting back in the chair and continuing this discussion with us. Thank you for your time.

And in the interest of fairness, I want to also mentioned that we did try to get Olivia Gans back with us too, who was representing the other side of the argument to make it a more balanced discussion. She had already apparently left the building. So we couldn't get her back, but we do appreciate Eleanor sitting down.

So bottom line, as we wrap up our hour here, again, explain to us, this pill has been approved, what does it mean to women, and what kind of option does it then bring in terms of an abortion choice that women didn't have before?

ROWLAND: Again this gives women who choose abortion to have another choice, an alternative to surgical abortion. Once again, it requires three visits to a doctor or a clinic on the first visit, you take three pills, mifepristone, that is what was FDA-approved today.

Two days later, the woman returns to the physician's office to take two pills of misoprostol. This a drug that is already FDA- approved. This will then bring on the abortion. It should begin six hours after that, a woman returns home. The whole process from there could take as long as two weeks. And then she returns once again, third visit, to make sure that the abortion is complete.

KAGAN: And the cost about $300, similar to a surgical procedure.

ROWLAND: That is right.

KAGAN: Rhonda Rowland, you have been a huge wealth of information as this news broke in this hour. Appreciate it. Thank you very much.

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