3.0.0 2101 2023-01-11T13:27:33Z 2023-01-11T13:27:33Z House HR 2015-04-29 114 [Congressional Record Volume 161, Number 63 (Wednesday, April 29, 2015)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. COOPER:H.R. 2101.Congress has the power to enact this legislation pursuantto the following:The Constitutional authority in which this bill rests isthe power of the Congress to regulate Commerce, as enumeratedby Article I, Section 8, Clause 3 of the United StatesConstitution.[Page H2655]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2015-05-01T15:21:42Z Referred to 2015-04-29T13:01:40Z 2015-05-01 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2015-04-29 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2015-04-29 Introduced in House IntroReferral Intro-H 9 Library of Congress 2015-04-29 Introduced in House IntroReferral 1000 9 Library of Congress C000754 Rep. Cooper, Jim [D-TN-5] JAMES COOPER D TN H. 5 N L000571 Rep. Lummis, Cynthia M. [R-WY-At Large] Cynthia Lummis R WY M. 0 2015-04-29 True L000397 Rep. Lofgren, Zoe [D-CA-19] ZOE LOFGREN D CA 19 2015-07-28 False D000216 Rep. DeLauro, Rosa L. [D-CT-3] ROSA DELAURO D CT 3 2015-07-29 False S001145 Rep. Schakowsky, Janice D. [D-IL-9] JANICE SCHAKOWSKY D IL D. 9 2015-11-18 False W000187 Rep. Waters, Maxine [D-CA-43] MAXINE WATERS D CA 43 2015-11-18 False J000294 Rep. Jeffries, Hakeem S. [D-NY-8] Hakeem Jeffries D NY S. 8 2015-11-18 False N000002 Rep. Nadler, Jerrold [D-NY-10] JERROLD NADLER D NY 10 2015-12-09 False H001047 Rep. Himes, James A. [D-CT-4] James Himes D CT A. 4 2016-05-13 False R000602 Rep. Rice, Kathleen M. [D-NY-4] Kathleen Rice D NY M. 4 2016-09-06 False V000081 Rep. Velazquez, Nydia M. [D-NY-7] NYDIA VELAZQUEZ D NY M. 7 2016-09-06 False 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 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 Health 00 2015-04-29 Introduced in House 2015-08-13T22:28:03Z 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.

]]> Research for All Act of 2015 Display Title Research for All Act of 2015 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to provide for expedited review of drugs and biological products to provide safer or more effective treatment for males or females, to amend the Public Health Service Act to enhance the consideration of sex differences in basic and clinical research, and for other purposes. Introduced in House IH Short Titles as Introduced Research for All Act of 2015 Introduced in House 2015-04-29T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114hr2101ih/xml/BILLS-114hr2101ih.xml 2015-05-01 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.