By Tom Strode
WASHINGTON (BP)--The federal government has approved the abortion drug RU 486, ending a controversial effort that required nearly all eight years of the Clinton administration to complete.
The Sept. 28 announcement by the Food and Drug Administration served as a double blow to the pro-life movement. First, and most significant, a more secretive method of killing unborn children was approved by the United States government. Second, restrictive guidelines proposed by the FDA in June for the use of RU 486 were eliminated in the final version.
Pro-lifers decried the FDA action.
"The FDA's decision is a tragic one for women and for our unborn citizens," said Richard Land, president of the Southern Baptist Ethics & Religious Liberty Commission. "This is a dangerous drug that is fatal for unborn babies and hazardous to their mothers."
Laura Echevarria, spokeswoman for the National Right to Life Committee, said in a written release, "The Clinton-Gore administration, which claimed it wanted to make abortion rare, has embraced an abortion pill that will result in more abortions and new risks to women."
RU 486, also known as mifepristone, is used with another drug to induce abortion normally in the first seven weeks of pregnancy. Mifepristone, which will use the trade name Mifeprex in this country, causes the lining of the uterus to release the baby, who usually suffocates or starves to death. The other drug, misoprostol, is taken two days after mifepristone and causes the uterus to contract, expelling the child. Women return to the doctor's office about 14 days after taking mifepristone to determine if the abortion has been completed.
Under the FDA's guidelines, RU 486 will not be available in pharmacies but from doctors who meet some minimal qualifications. In order to disperse the drug, doctors must be able to date pregnancies and diagnose tubal pregnancies. They must also be able to do surgery if necessary for an incomplete abortion or severe bleeding, or they must have made arrangements for a surgeon.
The FDA, however, did not include some stringent rules it had proposed and that were revealed by abortion advocates in early June, according to The Washington Post. Those included a national registry of all doctors who prescribed RU 486 and a requirement such physicians must have admitting privileges at a hospital within one mile of their offices. Such restrictions would have made the process not nearly as secretive as abortion advocates had expected, and pro-choice leaders complained they would severely limit the use of RU 486.
"Only four months ago, after years of study, the FDA recognized the substantial risks of this two-drug abortion method. ... Now, four months later, the FDA has dropped most of these protections for women's health," said Randall O'Bannon, NRLC's director of education, in a written statement. "What has changed other than a four-month campaign of political pressure by the abortion industry and its allies? The FDA opted for the convenience of abortionists over the safety of women."
The FDA acknowledged there are possible side effects to taking RU 486, including severe bleeding, cramping, vomiting and dizziness. Pro-life advocates expressed concerns for the emotional and physical health of mothers who abort their children with the drug.
"Women who would never consider a surgical abortion will now naively proceed in this game of 'health roulette,' believing that the FDA's stamp of approval proves this drug to be safe and effective," said Carrie Earll, bioethics policy analyst for Focus on the Family, in a written release.
The ERLC's Land said, "It is instructive that despite the intense pressure of the Clinton-Gore administration the FDA has taken nearly eight years before finally authorizing the drug's use.
"Like many people who have dealt with some of the tens of thousands of women who have been victimized by post-abortion stress syndrome, I am extremely concerned that the use of RU 486 is going to exponentially increase the numbers of such emotionally traumatized women," Land said. "However emotionally traumatic a surgical abortion is, and multitudes of women have testified to its trauma, the abortion procedure itself is over in a fairly short period of time. With a RU 486 pharmaceutical abortion, a woman has to live with what she is doing and the painful contractions and ultimate abortion of her baby for a period of several days. One can only imagine the unexpected and overwhelming anguish and remorse that many mothers will feel as they experience this terrible process."
Abortion advocates hailed the FDA decision. Kate Michelman, president of the National Abortion and Reproductive Rights Action League, said in a written release the approval of RU 486 was "one of the most significant advances in women's reproductive health that we have seen in decades."
The drug will be distributed by Danco Laboratories, a New York company. Danco has an agreement to manufacture RU 486 in China, according to The Wall Street Journal. The communist giant has a coercive abortion and sterilization policy that has been enforced in many provinces.
The major presidential candidates are split over RU 486. Vice President Al Gore favored its approval, while Republican George W. Bush has been opposed.
The FDA decision only four months before President Clinton leaves office assures he will have the introduction of RU 486 into this country as part of his legacy. The abortion pill's long road to approval began on the third day of Clinton's presidency when he directed the FDA to determine if the import ban on RU 486 should be lifted. President Bush had banned the pill.
The ERLC and other pro-life organizations had long resisted attempts to introduce RU 486 into the United States. In December 1990, Land and 10 other pro-life leaders traveled to Europe to assure Roussel Uclaf and its German parent company there was widespread opposition to the introduction of RU 486 into this country.
In 1994, Roussel Uclaf donated the U.S. patent to the Population Council, a New York-based, nonprofit group. The FDA issued the original approvable letter for RU 486 in 1996.
Congressional attempts to ban the pill's approval have failed. Twice the House of Representatives approved such legislation, but the Senate failed to follow its lead.
RU 486 is already available in such countries as France, Great Britain, Spain, Sweden, Russia, China and Israel, according to The Post.
Used with permission.