ABSTRACT
The problem of illness caused by "correctly" prescribed medication has attracted a fair amount of attention recently. This chapter focuses on a somewhat different but related problem, one connected with deciding what a "correct drug" is and what an appropriate dosage is for women. It is concerned with the problem of ensuring the inclusion of women in the clinical testing of drugs required to determine their safety and efficacy. The chapter considers positions taken by the United States (US) Federal Drug Administration, which regulates medical drugs and devices in the US, in some detail. It also focuses on the role women play in agency-required testing of the products. Reflecting the growing concern about the effects of drugs on women, the new guideline claimed to increase the number of women involved in clinical trials— without sacrificing their safety. By contrast, the regulations governing drug trials in the European Union make no specific reference to gender.
