Blog Archives

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.

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Posted in Issue 24 (December 10), Update, Volume 38 (2019)

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 hearing was held in the House in July.


In his opening statement, Chairman Alexander acknowledged the continued enthusiastic, bipartisan support for NIH, evidenced by the passage of the 21st Century Cures Act in 2016 and by substantial budgetary increases provided to the agency over the last four years (see COSSA’s funding analysis for details). He further stated, “It’s hard to think of a major scientific advancement since World War II that has not been supported by federal research funding. But we’re not the only country that’s figured that out. Other countries have seen that investments in basic research can lead to breathtaking new discoveries,” pointing specifically to China.

Chairman Alexander raised concern about reports that some federally funded research is being conducted by “bad actor” foreign nationals who may be trying to assert undue foreign influence on NIH research. Dr. Collins explained that through an internal investigation, NIH found that the risks to the security of intellectual property and the integrity of the peer review process are increasing in magnitude. In response, Dr. Collins recently wrote to 10,000 NIH grantee institutions requesting that they “review their records for evidence of malfeasance,” specifically: (1) failure by researchers to disclose substantial contributions of resources from other organizations, including foreign governments; (2) diversion of intellectual property to other entities, including foreign governments; and (3) failure by some peer reviewers to keep grant applications confidential or other attempts to influence funding decisions. In addition, Dr. Collins has formed a Working Group on Foreign Influences on Research Integrity, which will continue to look at these challenges.

Dr. Collins used his prepared remarks to highlight NIH advancements made possible with the infusion of new funds from the 21st Century Cures Act. He outlined what he called the five keys to success in science today. They include: (1) a stable trajectory of support (i.e. funding); (2) a vibrant workforce (e.g. training programs); (3) computational power, which is enabling activities like the BRAIN initiative and the All of Us Precision Medicine Initiative; (4) new technologies and facilities; and (5) scientific inspiration.

Of particular interest to the social and behavioral science community, Senator Michael Bennet (D-CO) asked about whether our society is becoming addicted to technology and about the public health effects of social networking, citing findings from a recent study on daily use of technology and social media among teens (Psychology of Popular Media Culture, APA). Senator Bennet called for more priority to be placed on research in these areas and asked what NIH is doing in this space. Dr. Collins cited the Adolescent Brain Cognitive Development (ABCD) Study, which will follow 10,000 children ages 9-10 into early adulthood, studying brain, social, cognitive and emotional development and the factors that influence them. The issue of “screen time” is among the factors to be studied. In addition, Dr. Bianchi mentioned a recent NICHD workshop looking at new research directions in these areas, including early childhood language development, reading comprehension, parent-child interactions, and technology addiction.

Other Senators asked questions on a variety of specific diseases and topics of interest to them, including opioid and other addictions, the societal costs of obesity, development of a universal flu vaccine, maternal health, and bolstering researchers from underrepresented groups.

Dr. Collins’ testimony and a video of the hearing can be found on the HELP Committee website.

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Posted in Issue 17 (September 4), Update, Volume 37 (2018)

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 officials on the progress of the Cures investments. Witnesses included Francis Collins, Director, National Institutes of Health; Stephanie Devaney, Deputy Director, NIH All of Us Research Program; Scott Gottlieb, Commissioner, Food and Drug Administration; and Norman Sharpless Director, National Cancer Institute. A related hearing on the mental health provisions within Cures was held on July 19.

In his prepared remarks, Dr. Collins highlighted NIH’s efforts and successes through the Cancer Moonshot and the All of Us Precision Medicine Initiative, both made possible through Cures Act investments. Committee members asked questions on a variety of topics, including concerns about privacy of patients and patient data within the All of Us program, NIH’s efforts to relieve administrative burden on investigators, and progress made toward cures and treatments for specific diseases and conditions.

Video of the hearing and witness testimony can be found on the Energy and Commerce Committee website.

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Posted in Issue 16 (August 7), Update, Volume 37 (2018)

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.

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Posted in Issue 22 (November 14), Update, Volume 36 (2017)

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 to states to assist in fighting the opioid epidemic, and provides a boost for mental health care. (more…)

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Posted in Issue 23 (December 13), Update, Volume 35 (2016)

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 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.
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Posted in Issue 19 (October 4), Update, Volume 35 (2016)

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 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…)

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Posted in Issue 9 (May 3), Update, Volume 35 (2016)

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 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…)

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Posted in Issue 2 (January 26), Update, Volume 35 (2016)

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.) (more…)

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Posted in Issue 13 (July 14), Update, Volume 34 (2015)

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 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…)

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Posted in Issue 11 (June 16), Update, Volume 34 (2015)


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