United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 2001-07-06 monographic deposited born digital 40 p. GA 1.13:GAO-01-754 https://www.govinfo.gov/app/details/GAOREPORTS-GAO-01-754 P0b002ee180374897 f:d01754 DGPO 2010-08-12 2011-03-28 GAOREPORTS-GAO-01-754 machine generated eng fdlp REPORT GAOREPORTS-GAO-01-754 GAO-01-754 Health research programs Pharmaceutical industry Pharmacological research Women Drugs Product safety Other Written Product A01149 This report reviews the Food and Drug Administration's (FDA) inclusion of women in clinical drug trials. GAO found that women were a majority of the clinical trial participants in the new drug applications (NDA) it examined and that every NDA included enough women in the pivotal studies to be able to statistically demonstrate that the drug is effective in women. Although these findings are welcome, GAO also found three areas of concern. The first is the relatively small proportion of women in early small-scale safety studies. These early studies provide important information on drugs' toxicity and safe dosing levels for later stages of clinical development, and many of the NDAs GAO examined found significant sex differences in a drug's pharmacokinetics, or how it is absorbed, distributed, metabolized, and excreted, and concentrated in the bloodstream. Second, GAO is not confident that either NDA sponsors or FDA's reviewers took full advantage of the available data to learn more about the effects of the drug in women and to explore potential sex differences in dosing. This is because NDA summary documents are not required to include analyses of sex differences, and many of them do not. Third, FDA lacks appropriate management systems to monitor how many women are in clinical trials, to be certain that NDAs and investigational new drug applications (IND) annual reports comply with regulations for presenting outcome data by sex and tabulating the number of women included in ongoing trials, and to confirm that its medical officers have adequately addressed sex-related issues in their reviews. Although FDA has taken some promising initial steps to address these deficiencies, it is important that the agency finalize the pilot programs it has underway and give sustained attention to these management issues https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-01-754/html/GAOREPORTS-GAO-01-754.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-01-754/pdf/GAOREPORTS-GAO-01-754.pdf GAO-01-754 https://www.govinfo.gov/app/details/GAOREPORTS-GAO-01-754 Other Written Product GAO-01-754; Women's Health: Women Sufficiently Represented in New Drug Testing, but FDA Oversight Needs Improvement; Health research programs Pharmaceutical industry Pharmacological research Women Drugs Product safety Public Law 105-115