H.R.4879 - Research for All Act of 2014113th Congress (2013-2014)
|Sponsor:||Rep. Cooper, Jim [D-TN-5] (Introduced 06/17/2014)|
|Committees:||House - Energy and Commerce|
|Latest Action:||House - 06/20/2014 Referred to the Subcommittee on Health. (All Actions)|
This bill has the status Introduced
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Summary: H.R.4879 — 113th Congress (2013-2014)All Information (Except Text)
Introduced in House (06/17/2014)
Research for All Act of 2014 - Directs the Food and Drug Administration (FDA) to review and develop policies to ensure that the design and size of clinical trials for products granted expedited approval to treat a serious or life-threatening disease or condition are sufficient to determine the safety and effectiveness of the products for men and women using subgroup analysis.
Amends the Federal Food, Drug, and Cosmetic Act to require FDA, at the request of the sponsor of a new drug, to facilitate the development and expedite its review if the drug is:
- intended to avoid serious adverse events or to treat a serious or life-threatening disease or condition,
- intended for safer or more effective treatment for either men or women than a currently available product approved to treat the general population or the other sex, and
- supported by results of clinical trials that include and separately examine outcomes for men and women.
Amends the Public Health Service Act to require the Director of the National Institutes of Health (NIH) to determine when it is appropriate for projects of basic research involving cells, tissues, or animals to include both male and female cells, tissues, or animals. Requires, in such cases, disaggregation of results according to sex. Provides guidelines for ensuring that sex differences are examined and analyzed.
Authorizes the Secretary of Health and Human Services (HHS) to support the continued operation and expansion of Special Centers of Research on Sex Differences.
Requires the Comptroller General (GAO) to provide to Congress updated versions of 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,” including in the reports examination of:
- the inclusion of women, female animals, and female-derived cells and tissues in federally funded research over the past decade;
- federal reporting and analysis of subgroup information and the translation of differences to the medical community and patients;
- the effect of inclusion rates in research on the quality of women’s health care; and
- current efforts within government agencies to encourage the sharing of research data on sex differences and mechanisms to improve such sharing.