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May 17, 2017: ASPET Government Affairs and Science Policy Update

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NIH appropriations hearing scheduled; FY 2018 outlook; More transitions 

NIH Hearing Scheduled: The House Labor-HHS-Education Appropriations Subcommittee has scheduled a hearing on the NIH for Wednesday, May 17, 2017 at 10 a.m. NIH Director Francis Collins, MD, PhD, is scheduled to testify and will be accompanied by five institute directors. 

Witnesses: Dr. Francis Collins, Director, NIH; Dr. Anthony S. Fauci, Director, NIH, National Institute of Allergy and Infectious Diseases; Dr. Gary Gibbons, Director, NIH, National Heart, Lung and Blood Institute;Dr. Joshua Gordon, Director, NIH, National Institute of Mental Health; Dr. Doug Lowy, Acting Director, NIH, National Cancer Institute; Dr. Nora Volkow, Director, NIH, National Institute of Drug Abuse

This hearing will be webcast and ASPET will provide a summary.

Press Reports on White House Meeting on Biomedical Research: On May 8, NIH leaders spent two hours with top administration officials and President Trump discussing the economic and human-health importance of the federal investment in medical science. No specific figures were discussed. As reported in the Chronicle, Director Collins, flanked by four pharmaceutical company leaders, used the opportunity to reiterate his message that private industry drives the U.S. economy, but it must have public-sector investment in research at key points to make the system work. As previously reported in March, the administration recommended to Congress a fiscal 2018 budget plan that would slice NIH spending from $31.7 billion down to $25.9 billion.

FY 2018 Appropriations: With only a little over four months left before the new fiscal year begins on Oct. 1, in addition to a compressed calendar, a delayed presidential budget request, the lack of agreement on spending limits, and a renewed focus on health care legislation, the fiscal 2018 appropriations process looks to be a steep uphill battle yet again. A stopgap spending measure will almost certainly be necessary to avoid a government shutdown come September 30.  

Conversations with staff confirm that clearing appropriations bills this year will be a heavy lift; as it is, the current timeline would require the Committee to take up two bills per week- and progress will be largely dependent upon the overall spending level set in the forthcoming budget resolution (coming sometime after the Memorial Day recess). If the budget resolution ultimately cuts NDD (which we expect it will, given the goal of balancing the budget in 10 years without cuts to Medicare and Social Security) we could expect a repeat of 2013 where it becomes very hard to move bills.

As we enter a potentially challenging FY 2018 advocacy climate, it will be important for the community to remain unified in support of sustainable, predictable growth for the agency. Additionally, ASPET is joining efforts coordinated by NDD United and the Coalition for Health Funding to ensure the highest possible investments in non-defense discretionary spending and the Labor-HHS-Education 302(b) allocation, which will facilitate greater investment in NIH and other health priorities.

FDA, AHRQ Transition Watch:  The Senate recently confirmed (57-42) Scott Gottlieb to head the FDA.  At his Senate confirmation hearing in April, Gottlieb said tackling the opioid epidemic was the "biggest crisis facing the agency." Gottlieb will lead the charge against opioid abuse in his new position, and will also play a key role in implementing legislation passed in the last Congress to expedite the approval of medical drugs and devices. Five Democrats voted for his confirmation, including Senators Michael Bennet, Tom Carper, Chris Coons, Heidi Heitkamp, and Bill Nelson. Gottlieb served as FDA deputy commissioner under President George W. Bush.

Additionally, the Agency for Healthcare Research and Quality (AHRQ) announced the appointment of its new Director, Gopal Khanna. Mr. Khanna brings a wealth of public-sector experience in federal and state governments and is specialized in data-driven strategies to improve organizational performance. The AHRQ Director does not require Senate confirmation.

NIH Announces Preliminary Plans for New Approach to Grant Funding: On May 2, NIH Principal Deputy Director, Larry Tabak, DDS, PhD, led a stakeholder conference call to introduce a grants policy change that will be implemented over the next few months called the Grant Support Index (GSI). The purpose of this change is to allow NIH to address concerns regarding the long-term stability of the biomedical research enterprise. While Dr. Tabak noted several key grants policy changes put in place in the wake of the 2012 report of the Biomedical Workforce Working Group of the Advisory Committee to the NIH Director, these changes have had only moderate success in addressing the balance of funding across career stages. 

Citing analyses that show that 10 percent of investigators receive 40 percent of NIH funds as well as the diminishing returns on productivity from investigators with three or more R01 grants, Dr. Tabak introduced the GSI as a mechanism for balancing NIH funding across the research community.  The need for such a mechanism has been highlighted in several publications, including a 1985 paper by Bruce Alberts and more recently, FASEB’s 2015 report, Sustaining Discovery in the Biomedical and Biological Sciences. While NIH is still developing the specific parameters of the GSI and plans to actively engage the stakeholder community in this process, Dr. Tabak outlined several key components, listed below:

  • GSI will assign a point value based on grant complexity or size
  • Investigators will not be defunded if they hit the GSI cap; NIH anticipates rolling out the policy so that a new grant submission would trigger a process in which the applicant would have to provide a plan for how to balance their NIH funding portfolio
  • GSI would automatically be calculated by ERA, minimizing administrative burdens
  • NIH anticipates that the “cap” score will be 21, but they are still working on the scale and specific point values for grant types/roles
  • The cap is anticipated to affect only 6 percent of NIH funded investigators but will free up approximately $500M - $650M (1,500-1,600 new awards)
  • Details of the implementation plan to be informed by stakeholders, including all IC Councils (all will discuss this during May meetings) and requests for input from community

ASPET will provide updates regarding implementation of this new policy as more information becomes available.

Last updated: May 17, 2017 

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