21st century cures act
Cures 2.0 Bill Introduced in the House, Includes RISE Act and ARPA-H Authorization
On November 16, Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) introduced the Cures 2.0 Act, long anticipated legislation aiming to bolster the U.S. biomedical research enterprise. Most notably, the legislation would authorize $6.5 billion for an Advanced Research Projects Agency for Health (ARPA-H), a long-touted Biden Administration priority. Unlike the previously introduced Advanced Research Project Agency-Health (ARPA-H) Act (H.R. 5585) which authorizes $3 billion for an independent ARPA-H within the Department of Health and Human Services, the Cures 2.0 Act would establish ARPA-H within the National Institutes of Health (NIH) (see previous coverage for more details). In addition to…
Members of Congress Request Feedback on Cures 2.0 Legislation
On November 22, Congresswoman Diana DeGette (D-CO) and Congressman Fred Upton (R-MI) released a statement detailing a vision for an updated version of the 21st Century Cures Act and calling for stakeholder input. The proposed legislation, colloquially known as “Cures 2.0,” would provide funding for research into cures for several life-threatening diseases. The Members will accept stakeholder comments until December 16. Information on how to submit comments can be found in the Members’ statement. Back to this issue’s table of contents.
Senate HELP Committee Hears Update on NIH Cures Implementation
On August 23, the Senate Health, Education, Labor and Pensions (HELP) Committee held an oversight hearing featuring leadership from the National Institutes of Health (NIH). The hearing, Prioritizing Cures: Science and Stewardship at the National Institutes of Health, was chaired by HELP Committee Chairman Lamar Alexander (R-TN) and included testimony from NIH Director Francis Collins. Dr. Collins was joined by Diana Bianchi, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Anthony Fauci, National Institute of Allergy and Infectious Diseases (NIAID); Richard Hodes, National Institute on Aging (NIA); and Norman Sharpless, National Cancer Institute (NCI). A similar…
House Holds Hearing on Cures Implementation
On July 25, the House Energy and Commerce Subcommittee on Health held an oversight hearing on 21st Century Cures Implementation: Updates from FDA and NIH. The 21st Century Cures Act is legislation enacted in 2016 that, among other things, provides for additional funding for biomedical research at the National Institutes of Health (NIH). Authorized in the act, the Cures funding is provided through the annual appropriations bills to boost funding for priority research in areas, including the Beau Biden Cancer Moonshot initiative, the BRAIN initiative, and the All of Us Precision Medicine Initiative. The hearing offered an update from agency…
NIA Releases Request for Information on Challenge Prize for Alzheimer’s Research
On November 2, the National Institute on Aging (NIA) of the National Institutes of Health (NIH) released a Request for Information (RFI) to solicit feedback and ideas for a Challenge Prize on Alzheimer’s and related dementias research. This Challenge Prize is being conducted as part of the implementation of the 21st Century Cures Act and is the first Challenge Prize from the NIA. The institute is requesting suggestions for what prize goals should be established and other specific ideas for what should be considered in the Challenge Prize. Responses must be submitted by December 31. Back to this issue’s table…
21st Century Cures Act Becomes Law
In a display of bipartisanship, Congress passed the 21st Century Cures Act. The House overwhelmingly passed an updated version of the bill (H.R. 34) on November 30 by a vote of 392 to 26. On December 7, the Senate followed suit with its consideration of the bill and passed it by a recorded vote of 94 to 5. President Obama signed the bill on December 13. The comprehensive bill provides an infusion of funding for biomedical research at the National Institutes of Health (NIH), directs the Food and Drug Administration (FDA) to approve drugs and devices with greater urgency, provides resources…
Congressional Supporters of 21st Century Cures Bill Hope for Passage by End of 114th Congress
Supporters of the 21st Century Cures legislation have not given up on seeing the legislation become law in the 114th Congress. On September 28, the Chair and Ranking Member of the Senate Health, Education, Labor and Pensions (HELP) Committee, Sen. Lamar Alexander (R-TN) and Sen. Patty Murray (D-WA), respectively, released the following statement: “We continue our work on bipartisan legislation to spur cures and treatments and better health for Americans. We’ve been working for a year and a half on behalf of patients and scientists, and we are committed to getting a result this year that will lead to lifesaving medical breakthroughs…
Senate Health Committee Advances Biomedical Innovation Bills
On April 6, the Senate Health, Education, Labor and Pensions (HELP) Committee held the third in a series of hearings (March 16 and March 9) to complete its work on companion legislation to the 2015 House-passed 21st Century Cures Act. Opening the hearing, HELP Committee Chairman Lamar Alexander (R-TN) noted that the committee has completed action on approximately 50 bipartisan proposals via 10 hearings and five staff working groups that held more than 100 meetings. The proposals resulting from these deliberations form the Senate’s companion legislation to the 21st Century Cures Act. The legislation also serves as the means of…
Senate HELP Committee Begins Consideration of Companion Legislation to the House 21st Century Cures Act
Senator Lamar Alexander (R-TN), Chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, recently announced that the committee will hold the first of three executive sessions to consider legislation to address biomedical innovation. The legislation affects the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). The bills would serve as the companion legislation to the 21st Century Cures Act passed by the House last summer (see Update, July 14, 2015). The executive sessions are planned for February 9, March 9, and April 6. Alexander stressed that the Committee worked throughout 2015 to produce the…
21st Century Cures Act Passes the House with Bipartisan Support
On July 10, the House of Representatives passed the bipartisan 21st Century Cures Act (H.R. 6) by a 344 to 77 vote. In addition to reauthorizing the National Institutes of Health (NIH) for three years, the bill as passed would provide $9.3 billion in advanced appropriations for fiscal years (FY) 2016-2020 for a new NIH Cures Innovation Fund and $110 million annually for the Food and Drug Administration’s (FDA) regulatory modernization activities. (See COSSA’s analysis of the bill here.)
Members of Congress Address NIH Precision Medicine Working Group Workshop on Digital Health Data and Research Cohort Design
Senator Lamar Alexander (R-TN) and Representative Marsha Blackburn (R-TN) addressed a special session of the National Institutes of Health (NIH) Advisory Council to the Director (ACD) Precision Medicine Initiative Working Group at the Public Workshop, Digital Health Data and Research Cohort Design, on the campus of Vanderbilt University on May 28-29. The workshop is part of series by the ACD Working Group and builds on the April 28-29 workshop held on the NIH campus that focused on the development and implementation of a large national cohort, as well as identification of the unique scientific questions and opportunities of using such…
Analysis of the Draft 21st Century Cures Act
On May 14, the House Energy and Commerce Health Subcommittee approved by voice vote its discussion draft of the 21st Century Cures Act. An amendment to an earlier discussion draft was introduced by full committee Chairman Fred Upton (R-MI), Rep. Diana DeGette (D-CO), Health Subcommittee Chairman Joe Pitts (R-PA), full committee Ranking Member Frank Pallone, Jr. (D-NJ), and Health Subcommittee Ranking Member Gene Green (D-TX). The bipartisan amendment incorporated federal agency and scientific community feedback to a draft bill the preceding day. The legislation is scheduled to be considered by the full Energy and Commerce Committee the week of May…
House Energy and Commerce Committee Releases Second Version of 21st Century Cures Draft
On April 29, the House Energy and Commerce Subcommittee on Oversight and Investigations released the second iteration of the Committee’s 21st Century Cures bill (see Update, February 24, 2015). The latest draft is a collaborative effort by Chairman Fred Upton (R-MI), Ranking Member Diana DeGette (D-CO), Energy and Commerce full committee Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Chairman Joe Pitts (R-PA), and Health Subcommittee Ranking Member Gene Green (D-TX). The new version of the discussion draft would authorize the National Institutes of Health (NIH) for three years (FY 2016 through FY 2018), and increase its funding level by…
21st Century Cures Act Discussion Draft Released
House Energy and Commerce Committee Chairman Fred Upton (R-MI) released a discussion draft of the 21st Century Cures Act on January 27. The draft bill is the culmination of a year of hearings and roundtable discussions held by the Committee. Its release was accompanied by a section-by-section discussion of the document and a one-pager highlighting the legislative ideas. The Committee has repeatedly stated that the draft is a “starting point in the legislative process to spur discussion.” Accordingly, they are seeking public feedback on the proposals. The Committee also cautioned that the “inclusion of a policy in the draft should…