After years of research which kept women of childbearing age out of studies and away from treatments because they might get pregnant and the medication might harm the fetus, the FDA stated yesterday that it wants to delay any medical trial that discriminates on the basis of sex.
The FDA proposed regulations that would put on hold any trial that excluded women or men because of possible harm to the reproductive system. Although the FDA told drug companies in 1993 to include women equally at all stages of testing, in 4,000 clinical studies done in the past three years, 25% excluded women solely because of a pregnancy risk.
Women’s advocates attacked such discrimination, asserting that women should be told of the risks and allowed to make their own decisions. Being a part of a clinical trial is often the only way to get access to drugs for life-threatening diseases such as AIDS. The recommendation came after the National Task Force on AIDS Drug Development and the Presidential Advisory Council on HIV/AIDS advised that women not be excluded from AIDS drug testing, because many women with HIV are of childbearing age and should have equal access to the drugs.
The FDA said inclusion of women of all ages in studies is crucial to enable researchers to determine what doses should be used and how drugs should be labelled for women patients. Deputy Food and Drug Commissioner Mary Pendergast said the proposal “sends a strong message to the industry that we really do want them to open the doors of trials to women.”