Abortion foes bitterly denounced government
approval of the abortion pill RU-486 and vowed to continue to fight a
drug they called ``baby poison'' and a threat to women's health.
RU-486 was approved Thursday by the Food and Drug Administration,
ending a battle that has involved two presidents, several countries and
heated debate for 12 years.
Approval of the drug gives American women a pharmaceutical abortion
method already in wide use in France, Britain, China and 10 other
countries.
But since the FDA action took place in the closing weeks of a
national political campaign, it drew quick and heated comments from both
sides of the issue.
Texas Gov. George W. Bush, the Republican presidential nominee,
called the FDA decision ``wrong'' and said he feared that the
availability of RU-486 ``will make abortions more and more common.''
Health experts, however, said abortions did not increase after the
drug was introduced in Europe.
A Bush campaign spokesman said a president cannot order drugs off the
market, but, if elected, Bush would appoint an FDA commissioner ``to
make sure the FDA considered the risk and did not take this action as a
result of political pressure from the White House.''
Vice President Al Gore, Bush's Democratic opponent, supported
approval of the abortion pill, saying the decision was ``not about
politics, but the health and safety of American women and a woman's
fundamental right to choose.''
RU-486 was developed in France and became available there in 1988. In
1989, Bush's father, President George Bush, ordered the FDA to ban
importation of the drug for personal use. In 1993, President Clinton
ordered a re-evaluation of the ban and sought ways to provide RU-486 for
U.S. researchers after its French manufacturer refused to supply it.
Abortion opponent Rep. Chris Smith, R-N.J., called the abortion pill
``baby poison,'' adding that ``RU-486 is not just poison for babies, it
is potential poison for the mothers who take it.'' He said it can cause
prolonged bleeding and severe cramps.
Rep. Tom Coburn, R-Okla., promised legislation calling for severe
limits on which doctors could administer the abortion pill.
On the other side, Sen. Barbara Boxer, D-Calif., said the drug
provides an abortion method ``that avoids invasive surgery.''
``Today is a day that women should remember because their health and
their choices are finally being respected,'' she said.
The pill, known chemically as mifepristone and by the brand name
Mifeprex, will be available to doctors within a month.
Mifepristone blocks a hormone vital to sustaining pregnancy and works
only during the first seven weeks of pregnancy, when an embryo is about
one-fifth of an inch.
Two days after taking mifepristone, women take a second drug that
causes cramping and bleeding as the embryo is expelled, much like a
miscarriage.
``For those who choose to have an early termination of their
pregnancy, this is a reasonable medical alternative,'' said FDA
Commissioner Jane Henney. She approved mifepristone based on studies
that found it 92 percent to 95 percent effective in causing abortion.
Researchers say complications are rare, with serious bleeding in 1
percent of women. The pharmaceutical abortion does require three doctor
visits and the FDA restricted prescribing RU-486 to doctors with certain
training. The agency required that detailed patient-information
brochures be given to every woman.
But Smith claimed in a statement that a French study showed that out
of 950 women who used the drug, 270 required narcotics to control
intense pain and seven required blood transfusions.
Richard Hausknecht, medical director of Danco Laboratories, marketer
of mifepristone, called it ``a very, very safe drug.''
``At long last, science trumps anti-abortion politics and medical
McCarthyism,'' said Eleanor Smeal of the Feminist Majority Foundation.
Mifepristone may ``turn the tide against anti-choice intimidation,''
because doctors not offering surgical abortion can use the pill in
private offices instead of protester-targeted clinics, added Planned
Parenthood president Gloria Feldt.
A Kaiser Family Foundation survey of 767 physicians found that a
third of doctors who don't now provide surgical abortions would consider
prescribing RU-486.
But anti-abortion groups pledged to continue their opposition, with
Judie Brown of the American Life League saying: ``We will not tolerate
the FDA's decision to approve the destruction of innocent human persons
through chemical abortion.''
The pill's journey to the United States began in 1995, when French
manufacturer Roussel-Uclaf turned over U.S. rights to the drug to the
nonprofit Population Council of New York. The council began clinical
trials needed for FDA approval and created Danco Laboratories to market
mifepristone.
The FDA in 1996 declared mifepristone a safe and effective early
abortion method, but delayed full approval because Danco had problems
satisfying manufacturing and other final requirements.
President Clinton said the FDA's four-year investigation shows the
decision was ``purely one of science and medicine.'' He said the FDA
``bent over backward to do a lot of serious inquiries.''
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