Roanoke Times Copyright (c) 1995, Landmark Communications, Inc. DATE: THURSDAY, September 9, 1993 TAG: 9309090190 SECTION: NATIONAL/INTERNATIONAL PAGE: A-1 EDITION: METRO SOURCE: Associated Press DATELINE: WASHINGTON LENGTH: Medium
The committee of the National Academy of Sciences said the abortion pill RU-486 has been so extensively tested in France, Britain and Sweden that the FDA should expedite consideration of the drug for marketing in the United States.
Some in the FDA already have been thinking along those lines. In a letter to a congressman, made public in December, FDA Deputy Commissioner Carol R. Scheman said that the agency would welcome an application from a drug company for the marketing of RU-486 and that the agency possibly could find that European testing was enough to permit a full FDA review.
The independent academy report, in effect, endorses a speedy approval of the drug for abortion use early in pregnancy and calls for research on other uses for RU-486.
Researchers, the report said, should experiment with RU-486 as a "morning-after" pill to prevent pregnancy after unprotected sexual intercourse, and as a treatment for breast cancer and brain tumors.
Abortion politics kept RU-486 off the U.S. market during the Reagan and Bush administrations, but President Clinton in January called for research into the drug.
More than 60,000 women have used RU-486 for abortions in Europe. Because of the European experience, the NAS report said, an extensive U.S. drug trial such as the FDA normally would require "does not appear necessary" for the abortion use of RU-486 during the first trimester of a pregnancy.
RU-486, or mifepristone, is in a class of drugs called antiprogestins. Antiprogestins work by blocking or inhibiting the action of progesterone, a natural steroid hormone that is essential for maintaining pregnancy.
by CNB