Until now, the Food and Drug Administration's guidelines kept fertile women out of any clinical trial before its final stages and then only after generating animal data on a treatment's reproductive and teratogenic effects. Gender analysis refers to monitoring and recording differences in clinical data between men and women. Merkatz indicated that FDA plans to explore when and how pregnant women could participate in clinical trials, but gave no timetable or conditions. She said more active surveillance after marketing is crucial, as physicians now prescribe medications to an expectant mother with no specified data. The Department of Health and Human Services' regulations also restrict the use of pregnant women to clinical trials where treatment is therapeutic with minimal risk to the fetus.
Some legal scholars argue such policies are discriminatory and unconstitutional.
Researchers found that women who took the drug to prevent threatened miscarriages were more prone to breast cancer, and their daughters are now vulnerable to vaginal cancer. It is more than three decades since thalidomide, a sedative taken by expectant mothers, resulted in severely deformed babies. A 1991 NIH memorandum said underrepresentation of women in clinical studies has caused significant gaps in medical knowledge. The report criticized the NIH for scanty representations of women and minority subjects in federally funded, industry-sponsored research trials submitted as evidence for all drugs approved by the FDA since 1988. The landmark study coincided with a flurry of legislation and regulations that would mandate equal access to clinical trials.