ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Thursday, September 19, 1996 TAG: 9609190074
SECTION: NATIONAL/INTERNATIONAL PAGE: A-1 EDITION: METRO
DATELINE: WASHINGTON
SOURCE: Associated Press
NOTE: Below
The drug RU-486, an alternative to surgical abortion, passed its last major hurdle Wednesday on the way to becoming available to women in the United States.
The Food and Drug Administration said the French pill was safe and effective when used under a doctor's close supervision. But the FDA is withholding final approval until it receives more information about how the drug would be manufactured and labeled.
It should be in doctors' offices by mid- to late-1997, said Sandra Waldman, spokeswoman for the Population Council, the nonprofit group that has the U.S. rights to market the drug.
The drug, already used by 200,000 European women, has long been the focus of an emotional debate between abortion rights supporters and abortion opponents, who argue that making the drug available in the privacy of doctors' offices will increase the number of U.S. abortions.
The FDA sent a letter requesting further information Wednesday to the Population Council, the nonprofit group that has the U.S. rights to market the drug, known chemically as mifepristone.
Such letters are a common, usually minor, hurdle in the approval process.
``This FDA action marks another major step in the long and complex process to make mifepristone available to American women as it is to women in other countries,'' the council said in a statement.
``We are sure we will be able to provide the FDA the outstanding information necessary for approval.''
Once the FDA gets answers to its questions, it has up to six months to review the information. Agency officials would not estimate when the drug might reach doctors' offices.
The council started the drug approval process in March.
Abortion opponents accused the Clinton administration of rushing the approval process for political rather than sound medical reasons.
``We have no idea what the long-term impact on women's health will be by this politically motivated push to get this chemical into American women's bodies,'' said Kristi Hamrick, spokeswoman for the conservative Family Research Council.
To induce an abortion, the pregnancy-ending pill is followed two days later by another pill that causes strong uterine contractions to expel the fetus. The process can be painful and cause bleeding. It must be monitored closely, requiring three exams by a doctor.
FDA officials would not give details of the information they still seek. Labeling questions usually involve instructions and warnings for patients and doctors.
One of the most troubling questions for the FDA has been how to ensure that women return for the third medical exam, which comes after the pills are taken, to make certain the abortion was completed. If not, they need quick surgery.
Medical experts are concerned that many women, especially the poor and uninsured, might risk their health by skipping the final exam.
LENGTH: Medium: 62 linesby CNB