- The Washington Times - Friday, September 29, 2000

The Food and Drug Administration yesterday approved the RU-486 "abortion pill," a move that "pleased" Vice President Al Gore but Gov. George W. Bush called "wrong."
"People on both sides of the abortion issue can agree that we should do everything we can to reduce the number of abortions, and I fear that making this abortion pill widespread will make abortions more and more common, rather than more and more rare," Mr. Bush said.
"I think the FDA's decision to approve the abortion pill RU-486 is wrong. As president, I will work to build a culture that respects life," he said.
The vice president approved of the decision.
"Today's decision is not about politics, but the health and safety of American women and a woman's fundamental right to choose," Mr. Gore said.
"I am pleased with the Food and Drug Administration's decision… . After careful review and clinical tests, the Food and Drug Administration has determined that its use is safe and effective," he said.
The release of the drug, which has been in use in Europe for 12 years, was cheered by pro-choice groups and booed by several Republicans in Congress.
"Bill Clinton got the legacy he was looking for," said Rep. J.C. Watts Jr., Oklahoma Republican. "This is a sad day for America."
He questioned the origins of the drug, which according to the Wall Street Journal, is being manufactured in China.
"No first-world nation wants to export this lethal pill to the United States," he said. "Who is exporting this pill and what it actually contains is certainly one area Congress will look into."
President Clinton said the FDA "bent over backwards" to do its job.
"I regret some members of the other party have already tried to politicize it," he said. "I think it ought to be treated as the scientific and medical decision it was."
The National Abortion Federation called the approval a "milestone" in more than 27 years of legalized abortion in America.
"For the first time, American women who choose abortion will have the option of taking a pill to end a very early pregnancy," spokeswomen for the federation said in a statement.
"It is about time that American women have the same access as millions of other women around the world to this safe, effective and private option for early abortion," said Wayne C. Shields, president and chief executive officer of the Association of Reproductive Health Professionals. "Conditions of this approval also safeguard the privacy of physicians who provide this important service."
RU-486 is recommended for the first 49 days after a woman's last menstrual period, during which time the embryo has grown to an inch long and has formed ears, fingers and toes. The heart has begun beating, the kidneys are extracting waste and a tiny, primitive brain has already formed. It weighs no more than a whole peanut.
Women often don't suspect they are pregnant until well into the fifth week, the National Right to Life Committee (NRLC) said, meaning that much of the developing child's characteristics will already be visible to the woman having the abortion.
The NRLC has also raised questions about the drug's safety, as some of the women tested with the drug needed emergency blood transfusions. In clinical tests, one out of 100 women had excessive bleeding. The effect of the drug is to induce a miscarriage.
The FDA said the pill is restricted to doctors who can perform a surgical abortion if RU-486 did not complete the job. The same doctors must be able to determine the duration of a patient's pregnancy and whether it is an ectopic, or tubal, pregnancy, in which case the drug should be avoided.
The FDA also said the drug will be marketed by Danco Laboratories of New York under the name Mifeprex. Mifeprex will consist of two drugs taken over a two-day period during two visits to a doctor's office: mifepristone, which keeps the embryo from attaching to the uterine wall, and misoprostol, which induces the contractions that expel the fetus.
Women must return to the doctor a third time, about 14 days after taking the drug, to determine whether the abortion has occurred. This last visit is one of the more controversial steps in the process, as the FDA admitted during 1996 hearings on the pill that many women involved in clinical trials never came in for that last visit.
Opponents found that a problem.
"RU-486 … requires several doctor visits and the woman will deliver the child anywhere at work, in a grocery store, at a day care," said Wendy Wright of Concerned Women for America. "She will see and handle her baby's remains. She will have to take her baby's body to be checked to make sure every piece came out. If a portion is left inside, she will get an infection that could be fatal."
That is why the FDA instructs that each woman taking the drug be given a "medication guide" to explain how to take the drug, who should avoid taking it and what side effects can occur.
Proponents say the pill has been used by 620,000 European women, with minimal side effects.
"At long last, science trumps anti-abortion politics and medical McCarthyism," said Feminist Majority Foundation President Eleanor Smeal. "If this medication was primarily for men, the French developers would already have received a Nobel Prize in medicine."

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