Meanwhile, the 1977 FDA policy didn’t stop at excluding patients who were actually pregnant. It expressly prohibited women of “childbearing potential” from participating in early-phase drug studies, except in the cases of life-threatening diseases. Critics pointed out that this treated every menstruating woman as if she were potentially pregnant—a “walking womb”—an infantilizing position that implied women couldn’t be trusted to know their risk of unintended pregnancy, take steps to prevent it, and make their own decision should they accidentally become pregnant during the trial. Even lesbian women, single women, women using contraception, and women whose partners had had a vasectomy weren’t allowed. In a stark double standard, the policy evinced little concern at all that men of reproductive age could be exposed to drugs that harm the genetic material they contribute to their future offspring.
Maya Dusenbery, Doing Harm: The Truth About How Bad Medicine and Lazy Science Leave Women Dismissed, Misdiagnosed, and Sick
