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.
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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 to states to assist in fighting the opioid epidemic, and provides a boost for mental health care. (more…)
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 and advance President Obama’s Precision Medicine Initiative and Vice President Biden’s Cancer Moonshot.”
Similarly, a bipartisan group of House advocates for the House-passed 21st Century Cures Act
(H.R. 6) reiterated their support the legislation. The sponsors of H.R. 6, Energy and Commerce Committee Chair Fred Upton (R-MI), Rep. Diana DeGette (D-CO), and others noted: “We have been working hard for months, and we will continue to work toward an agreement that can pass both chambers and be signed by the president… At hand is a once-in-a-generation opportunity and we’re committed to getting 21st Century Cures signed into law this fall.”
It is unclear whether enough time remains to get a bill to the President’s desk before the 114th Congress concludes at the end of the year, especially given that the House and Senate are now on recess until after the November 8 elections, leaving only about 6 weeks to get it done.
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 codifying the President’s proposed Precision Medicine and Cancer Moonshot initiatives. The Chairman emphasized that the Senate’s “Innovation or ‘Cures’ legislation…will be the most important new law enacted this year.” (more…)
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 bills that are now ready for the full committee to consider, emphasizing the urgency required by the Senate to “finish its work and turn into law these ideas.”
Alexander specifically highlighted the committee’s work on legislation “to achieve interoperability of electronic health records” (EHRs). The Committee recently released a discussion draft of legislation along with a summary addressing health information technology (HIT), including EHRs, and is seeking comments. The discussion draft includes provisions to assist doctors and hospitals in improving quality of care for patients, establish Transparent Ratings on Usability and Security to Transform Information Technology (TRUST IT), provide the authority to investigate and establish deterrents to information blocking practices that interfere with appropriate sharing, foster a “network of networks” including establishing “an initial set of common data elements,” ensure that registries are certified to transmit and receive from certified HIT, provide “certification and development of patient-centered health record technology so that patients can access their health information through secure and user-friendly software, which may update automatically,” secure EHRs, and direct the Governmental Accountability Office (GAO) “to review methods for securely matching patient records to the correct patient.” (more…)
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.) (more…)
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 a large cohort. Two additional workshops are planned for July. The ACD Working Group is scheduled to submit its recommendations to the ACD at its September meeting, including a plan standing by to fund at the beginning of the fiscal year which begins October 1, should the Congress provide the necessary resources. (more…)
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 18; the Committee will convene for opening statements only on May 19 and on May 20 to mark up the bill.
Read on for COSSA’s full analysis of the bill.
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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 $1.5 billion each year. It also creates an NIH Innovation Fund for FY 2016 through FY 2020, financed by a mandatory appropriation of $2 billion a year. The Innovation Fund would be used to support precision medicine, young emerging investigators, and other priorities yet to be identified.
The section-by-section summary of the discussion draft is available online here. A one-page summary is available online here.
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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 not be seen as an endorsement.” (more…)