News Articles

Company expects to have RU 486 on market in 1999; Coburn to fight it

WASHINGTON (BP)–The American company with the license to RU 486 expects to have the abortion drug on the market by the end of 1999, according to a published report.
The Danco Group, a New York pharmaceutical company, is working with the U.S. Food and Drug Administration for final approval and has begun contacting doctors to discuss the best way to prescribe and administer the French-developed drug, a company spokesperson told The Washington Post.
Eleanor Smeal of the Feminist Majority Foundation, which has long promoted the use of RU 486 in this country, told The Post, “It appears that everything is finally in order.”
A Southern Baptist member of Congress plans to work against FDA approval of the drug, however. John Hart, press secretary for Rep. Tom Coburn, R.-Okla., told Baptist Press the congressman “will fight it.”
Last year, Coburn’s effort to block FDA approval of RU 486 succeeded in the House of Representatives but did not survive the Senate. Coburn offered an amendment to the 1999 agricultural appropriations bill that prohibited the FDA from using federal funds to develop or approve abortion-inducing drugs, including RU 486. The House approved the amendment in a 223-202 vote in June and easily passed the spending bill to which it was attached. The Senate did not include the amendment, however, and it was removed by the conference committee named to work out differences in the two versions of the spending bill.
A Southern Baptist bioethics specialist called the March 23 report “one small inch for the abortion industry and one giant step in the culture of death.”
“The news of the expected approval of RU 486 is bad enough, but what it portends for our culture is even worse,” said Ben Mitchell, ethics professor at Southern Baptist Theological Seminary. “We are rapidly getting used to the idea that homicide in the womb or homicide in the nursing home is morally acceptable. The abortion pill will just make it easier for our culture to salve its conscience, because abortion will be done in the privacy of one’s home instead of in the clinic on the corner.”
Pro-life organizations have long fought against RU 486’s introduction into the United States, but the abortion drug has been moving toward widespread availability for more than six years. That opposition and mistakes by the drug’s sponsors have helped prevent RU 486 from being available in the United States so far, according to The Post.
Danco announced last year it had finally found a manufacturer but has declined to name the company.
In the last 18 months, more than 3,000 women in this country have used RU 486 in a special, unadvertised research program sponsored by Abortion Rights Mobilization, The Post reported. The program, which was approved by the FDA in 1997, has been conducted at 15 sites, according to The Post. During the program, doctors have reduced the previously approved dosage from 600 to 200 milligrams and the number of visits to a physician’s office from three to two, The Post reported. They also have allowed women to take RU 486 vaginally at home rather than orally in an office, according to the paper.
RU 486, also known as mifepristone, is used with a prostaglandin, misoprostol, to induce abortion normally in the first seven weeks of pregnancy. Mifepristone causes the lining of the uterus to release the baby, who usually suffocates or starves to death. Misoprostol, taken two days after mifepristone, causes the uterus to contract, expelling the child’s body.
In late 1990, Richard Land, president of the Southern Baptist Ethics & Religious Liberty Commission, joined 10 other pro-life leaders in traveling to Europe to inform Roussel Uclaf, the French manufacturer of the pill, and its German parent company of American opposition to the introduction of RU 486 into this country.
Two days after he took office in 1993, President Clinton issued a directive clearing the way for importation of the abortion pill into this country. In 1994, Roussel Uclaf donated the U.S. patent to the New York-based Population Council.
Tests using RU 486 and misoprostol were performed on more than 2,100 women at 17 sites in the United States during 1994 and ’95, but the results were released by the Population Council only in 1998. The trials showed the two-step method successfully ended in abortion for 92 percent of women in the first seven weeks of pregnancy. It was successful 83 percent of the time in the eighth week and 77 percent of the time in the ninth week.
In 1996, the FDA declared RU 486 safe and effective but has withheld final approval pending examination of the manufacturer. A FDA spokesman declined comment because the application is under review, The Post reported.
Pro-lifers have warned RU 486 not only kills a child but poses a threat to the physical and psychological health of women. The U.S. tests showed 51 percent of women aborted after they left the clinic.
Ninety-nine percent of women participating in the trials reported some adverse effects, with 20 percent suffering severe nausea and 10 percent severe vomiting. Twenty-nine percent received narcotic painkillers. Fifty-six women required surgery for excessive bleeding, and four participants had blood transfusions.
The Post reported RU 486 is commonly used in France, Great Britain, Sweden and China, according to The Alan Guttmacher Institute.