<p>To the Director of the FDA Center for Drug Evaluation and Research,</p><p>I am writing to you today to express my concern after discovering that the FDA does not require medical research and drug trials to separate their findings by the sex of their participants. To get better data on the way women respond to specific drugs and treatment, this must change.</p><p>As you are no doubt aware, women and men do not always display the same signs, symptoms, or reactions to treatment. Symptoms of medical complications, such as heart attacks, are experienced differently in men and women. A general unfamiliarity of women's symptoms when they don't match men's has cost countless lives in the form of misdiagnosis. Women also absorb and react to medicine differently than men which can lead to complications and side-effects unanticipated by male-dominated drug trials.</p><p>I understand that in 1977, the FDA recommended that women of childbearing age essentially be excluded from clinical trials after medical disasters like the Thalidomide tragedy and synthetic estrogen known as DES, which led to malignancies in reproductive organs. I also realize that women's bodies also go through considerably more change then men's in the forms of menstruation, pregnancy, and menopause which can complicate research data sets.</p><p>While there is wisdom in the decision to limit women's participation in studies to protect the unborn, those women who do choose to participate in studies should not have their results scrutinized under the same standards as men. Quite simply, male and female bodies are different, and medical data should treat them as such.</p><p>Women need to benefit from medical trials by having researchers separate their data by sex. Please, change your policies to require studies to separate their results by male and female for the entire research process rather than lumping them together and to draw separate recommendations for the safe use of medicine for men and women.</p><p>Sincerely,</p>