At the request of Rep. Waxman and Senators Tom Harkin, Jim Jeffords, Barbara Mikulski, and Olympia Snowe, the General Accounting Office (GAO) investigated FDA’s progress in addressing the inclusion of women in clinical drug trials. While the report indicates that FDA has made some progress in ensuring the participation of women in trials, it identifies significant shortcomings in the inclusion of women in new drug development. GAO concluded that it was not confident that either the pharmaceutical companies or the FDA reviewers took full advantage of the available information to learn more about the effects of the drugs on women and to explore potential sex differences. In addition, GAO found that FDA does not currently have appropriate management systems in place to monitor how many women are in clinical trials or to confirm that its medical officers have adequately addressed sex-related issues in their review.