Research for All Act of 2015

Research for All Act of 2015

This bill directs the Food and Drug Administration (FDA) to ensure that the clinical trials for products granted expedited approval to treat a serious or life-threatening condition are sufficient to determine the safety and effectiveness of the products for men and women using subgroup analysis.

This bill amends the Federal Food, Drug, and Cosmetic Act to require the FDA, at the request of the drug sponsor, to facilitate development and expedite review of a new drug that is:

• intended to avoid serious adverse events or to treat a serious or life-threatening condition,
• intended for safer or more effective treatment for either men or women than a product approved to treat the general population or the other sex, and
• supported by results of clinical trials that separately examine outcomes for men and women.

This bill amends the Public Health Service Act to require the National Institutes of Health (NIH) to ensure that, when appropriate, basic research projects include both male and female cells, tissues, or animals. In such projects, results must be disaggregated according to sex and sex differences must be examined and analyzed. NIH must update guidelines on inclusion of women and minorities in research.

The Department of Health and Human Services may support the continued operation and expansion of Special Centers of Research on Sex Differences.

The Government Accountability Office must update the reports entitled “Women's Health: NIH Has Increased Its Efforts To Include Women in Research” and “Women's Health: Women Sufficiently Represented in New Drug Testing, But FDA Oversight Needs Improvement,” and include specified examinations.