The FDA Approves the Abortion Pill (2000)

Margaret Warner has the abortion pill story. Today's decision to approve the abortion pill RU486 was characterized by FDA Commissioner Jane Haney as giving women new choices. FDA is approval today of this drug, MIFA Pristone, essentially is the first medical alternative for early termination of pregnancy. So for women who are making a decision to terminate their pregnancy in those first 49 days, now have a choice whether it will be the more traditional surgical approach or this medical alternative. Abortion opponents have fought for more than a decade to keep this drug already available in Europe out of the U.S. market. The drug also known as MIFA Pristone can be used only within seven weeks of the patient's last menstrual period. A woman takes three MIFA Pristone

pills which block a hormone, progesterone, that's needed to maintain pregnancy. Two days later she returns to the doctor to take another already approved drug, mesoprostol. That drug triggers uterine contractions that expel the embryo. Under the new FDA guidelines, the woman must see her doctor a third time within two weeks for follow-up to make sure the abortion is complete. Side effects include bleeding, cramping, and nausea. And in about 5% of the cases in U.S. clinical trials, surgery was required to complete the abortion procedure. Nearly half a million women have used the drug in Europe in the 12 years since it was introduced in France by the pharmaceutical firm Rousselou Clough. Research in France has shown that the majority of women prefer this non-invasive technique of early pregnancy termination. But amid political pressure, the firm decided not to market RU486 in the U.S. Instead, it donated U.S. rights to a non-profit research group, the Population Council. The council

contracted with denco laboratories to market the pills. The drug's fate in the U.S. has been mired in abortion politics from the outset. In 1989, President Bush banned its import into the U.S. Four years later, President Clinton asked the FDA to reconsider. Here in the United States, RU486 has been held hostage to politics. It is time to learn the truth about what the health and safety risks of the drug really are. The FDA gave the drug preliminary approval in 1996, calling it safe and effective in terminating early pregnancies. But the agency said additional manufacturing and marketing concerns had to be addressed before final approval could be given. Today, in granting that final approval, the FDA added several requirements. The doctor has to be able to provide surgical, have the requisite surgical skills if those are needed to handle any problems that may arise or to have a physician that they can

refer to if those kind of interventions are needed. There are very strict requirements about where this drug will be stored and accounted for and the like to make sure that those doctors who desire to prescribe this drug are under obligations to the company for its use for its intended purpose. RU486 will be marketed under the brand name MIFA PREX and is expected to be available within a month. For more, we turn to Gloria Felt, president of the Planned Parenthood Federation of America, and Laura Echeveria, the chief spokesperson for the National Right to Life Committee. Ms. Felt, what is the significance of this medically for women? We applaud the FDA's decision today. It is a giant step forward for women, a quantum leap in reproductive health technology, and an option that American women have wanted

for many years so that we can have the same option that our sisters in Europe have had during all this time. It's been an arduous process. The scientific process has been long and arduous, but quite frankly, the political process has been even more arduous and longer and having to overcome those hurdles of the pressures of anti-choice hardliners who want to keep this very safe early option from American women has been quite a battle and we're very grateful that today the FDA has approved the early option. But let me just ask you about the medical side of this. For a woman who is seeking an abortion, how does this compare to the surgical alternative in terms of safety, risks, benefits? Well, since it is a very early option and the earlier in pregnancy that an abortion can be done, the safer it is, it is a very, very safe alternative. Also, the fact that it is done without surgery means that there are lower to virtually no risks of infection.

Now surgical abortion is also extremely safe and in any case, either of these options is much safer than carrying a pregnancy to term and full term and delivery. But it's very important for women to have the information and the counseling so that they can decide which one of these procedures best fits their personal needs. All right, Mr. Chivariya, how do you see this decision today? Well, we see it as a tragic and tragic, excuse me, tragic and sad that American women are going to suffer as a result of the use of RU-46 in the United States. Certainly, their child is going to die and that's something that is tragic right then and there of itself. But we also see that if RU-46 is administered to American women that certainly tragedies can result as a result of that, we know that there are side effects associated with RU-46 that can be quite severe, including nausea and vomiting and excessive bleeding. We know

that in the studies 2% of the women who take RU-46, hemorrhage severely enough that they require surgical intervention. And so certainly, we see this as a sad day for American women and certainly for unborn children.