Research for All Act of 2014
Latest action · Jun 20, 2014 Referred to the Subcommittee on Health.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedJun 17, 2014
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
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.
Cosponsors 13
Members who signed on, in the order they did. Signatures ran from Jun 17, 2014 to Dec 11, 2014, with 1 there on the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-WY | Cynthia M. Lummis | Original | Jun 17, 2014 |
| D-DC | Eleanor Holmes Norton | Jun 23, 2014 | |
| D-OH | Marcy Kaptur | Jun 23, 2014 | |
| D-NY | Louise McIntosh Slaughter | Jun 25, 2014 | |
| D-NJ | Rush Holt | Jun 25, 2014 | |
| D-IL | William L. Enyart | Jun 25, 2014 | |
| D-IL | Janice D. Schakowsky | Jul 3, 2014 | |
| D-VA | James P. Moran | Sep 8, 2014 | |
| D-MN | Keith Ellison | Sep 17, 2014 | |
| R-WI | Reid J. Ribble | Sep 17, 2014 | |
| D-AZ | Raúl M. Grijalva | Nov 13, 2014 | |
| D-FL | Alcee L. Hastings | Dec 4, 2014 | |
| D-CA | Maxine Waters | Dec 11, 2014 |
Actions 3
Everything that happened, newest first.
- Jun 20, 2014Referred to the Subcommittee on Health.
- Jun 17, 2014Introduced in House
- Jun 17, 2014Referred to the House Committee on Energy and Commerce.
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Administrative law and regulatory procedures
- Administrative remedies
- Congressional oversight
- Department of Health and Human Services
- Drug safety, medical device, and laboratory regulation
- Food and Drug Administration (FDA)
- Government studies and investigations
- Health
- Health care quality
- Health information and medical records
- Health programs administration and funding
- Medical research
- National Institutes of Health (NIH)
- Research administration and funding
- Women's health
Text 1
Each version as it was printed, newest first.
- Jun 17, 2014Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.