
                         Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: THURSDAY, July 22, 1993                   TAG: 9307220198
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A-3   EDITION: METRO 
SOURCE: Associated Press
DATELINE: BOSTON                                LENGTH: Short

FDA REMOVES BAN ON TESTING YOUNG WOMEN

The U.S. Food and Drug Administration lifted a ban Wednesday on testing experimental drugs in young women and said pharmaceutical companies now must make sure their products are safe and effective for both sexes.

The changes, outlined in a medical journal article being published today, are intended to help make sure that occasional differences in the way men and women react to new medicines are known before these drugs come on the market.

"This should help doctors individualize therapy and provide safer therapy," said Ruth Merkatz, primary author of the new rules at the FDA.

New drugs are widely tested in both sexes, although some, such as heart medicines, have been tried out more extensively in men.

However, until recently, the results of these studies were typically not analyzed to see if the sexes reacted equally.

An FDA guideline in effect since 1977 had forbidden including women with "childbearing potential" in the early stages of drug testing. Such women can take part in later, large-scale tests that are necessary for medicines to win FDA approval.

The ban was intended to protect fetuses from possible birth defects caused by exposure to experimental medicines. It has meant excluding all women before menopause, including lesbians, women who take birth control pills and those whose husbands have vasectomies.

Even though the ban has been removed, this does not guarantee that drug companies will open up early testing to younger women. The FDA acknowledged that worries about liability if fetuses are born with defects could keep pharmaceutical companies from venturing into this area.

by CNB