- The Washington Times - Thursday, September 28, 2000

The controversial RU-486, better known as the "abortion pill," could be approved as early as today by the Food and Drug Administration in a move timed for the closing months of President Clinton's administration.
The drug, which was approved by an FDA committee in the summer of 1996, has been dogged by delays ever since.
Release of the drug could be a point of contention between the two presidential candidates. Texas Gov. George W. Bush opposes it, and his father, President Bush, banned it from this country 11 years ago.
But Vice President Al Gore had favorable remarks about the drug during a Tuesday appearance on MTV that was broadcast from the University of Michigan at Ann Arbor.
"I think that it ought to be available, provided of course that it is safe," said Mr. Gore. "I think that what is wrong is to hold it off the market for some kind of political reason. I'm totally against that."
The FDA faces a deadline for approving the drug on Saturday, six months from the date the agency issued an "approvable letter" to the Population Council, a New York nonprofit group that has patent rights for the drug. The letter had additional questions it wanted answered.
"They wanted additional information regarding labeling and manufacturing," said Sandra Waldman, Population Council spokeswoman. By law, the FDA must take action within the six-month time period by either approving the drug, rejecting it, or issuing another approvable letter with more questions.
Because the Sept. 30 deadline is on a Saturday and because Friday is the start of Rosh Hashanah, the Jewish New Year, some observers predict the announcement will come today.
Funding for the drug, which is being marketed by New York-based Danco Laboratories LLC and the Population Council, includes money from foundations set up by billionaire financier Warren Buffet and hedge-fund czar George Soros, plus a $10 million loan from the David and Lucile Packard Foundation of Los Altos, Calif., according to the Wall Street Journal.
The Journal stated on Sept. 5 that Danco has contracted with a manufacturing plant in China to produce the drug. Because of America's strong pro-life movement, no U.S. drug company has been willing to take the risk.
"China is the land of forced abortions," said Randall K. O'Bannon, director of education and research for the National Right to Life Educational Trust Fund. "If they are going to go there and get the pill, that ought to tell you a lot about the product they've got," he said of the Population Council.
RU-486 is actually two drugs: mifepristone, which prevents an embryo from attaching to the uterine wall, and misoprostol, which induces the contractions that expel the fetus. Mifepristone is already in use in the United States in the form of the "morning-after pill."
But the FDA has never allowed the two drugs to be used in tandem. The RU-486 combination must be used within the first 49 days of pregnancy in conjunction with three visits to a doctor's office. Its backers contend it is safer than a surgical abortion.
Opponents say its failure rates range from 8 percent to 23 percent. In some cases, the bleeding can be quite heavy, as the effect of the drug is to induce a miscarriage. Proponents say it will benefit women in rural areas who must travel long distances to find an abortion clinic. In Europe, where the pill has been used for nearly a decade, 50 percent of women getting abortions have opted for the drug.
Joyce Price contributed to this report.

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