Washington Update

Inside (the Beltway) Scoop

By: Ellen Kuo
Wednesday, August 9, 2023
Twelve Appropriations Bills Advanced to Full Senate, Only the Military Construction Bill Passes the House 

The House Appropriations Committee did not complete full committee consideration of all 12 funding bills before leaving for recess. However, the House passed the Military Construction-Veterans Affairs (VA) funding bill (H.R. 4366) by roll call vote 380 (219 to 211) with all Democrats voting “No.” Amendment #25 by Rep. Lauren Boebert,(R-CO) which was accepted on the House floor, increased by $3 million the VA Medical and Prosthetic Research program to $941 million. Another accepted amendment to the Medical and Prosthetic Research account was to ensure that VA conducts large-scale studies into the efficacy of drugs that have Food and Drug Administration designated breakthrough therapy status to treat posttraumatic stress disorders.

At the same time, Senate appropriators completed their work for the fiscal year (FY) 2024 funding bills before leaving for recess by advancing them all for full Senate consideration. This was historic since it was the first time since 2018 that all 12 funding bills were voted out of the Senate Appropriations full committee as well as the first time in two years the committee has held markups.

The overwhelming bipartisanship to achieve this goal was done under the new all-female top leadership of Chair Patty Murray (D-WA) and Vice Chair Susan Collins (R-ME) as reflected in the Labor, Health and Human Services, and Education and Related Agencies (LHHS) bill (S. 2624) by a vote of 26 to 2, and the Military Construction-VA,  and Related Agencies Appropriation bill (S. 2127) by a vote of 28-0. In the LHHS bill, the National Institutes of Health (NIH) program level, excluding Advanced Research Projects Agency for Health (ARPA-H), was $47.2 billion, an increase of $265 million or 0.6 percent from FY 2023. ARPA-H was appropriated $1.5 billion available until September 30, 2026.

A total of $678 million in emergency supplemental funding was in the Senate LHHS bill. It was distributed to the National Cancer Institute ($216 million), the National Institute of Neurological Disorders and Stroke ($139 million), the National Institute of Mental Health ($139 million), and the Office of the Director ($184 million). 
This bill constitutes the largest share of nondefense discretionary spending, 28 percent of the total for regular base discretionary funding for FY 2024. Focused biomedical research funding went to mental health, Alzheimer’s disease, cancer, opioid addiction, diabetes, and maternal mortality. There was also $12 million allocated for a new palliative care research program.

Some interesting items in the Senate committee report included urging NIH to better understand the social determinants of health leading to inequity in access to diagnosis and care in frontotemporal degeneration (FTD). It noted the broad sharing of datasets will enable the larger community of researchers to bring their expertise to bear on the challenge of treating and preventing FTD, Alzheimer’s disease, and related disorders. NIH was also instructed to grow its ALS research portfolio and the workforce in this portfolio.

The committee also encourages NIH to find ways to support more effective communication across researchers, and between clinical science and broader society, to ensure that the research advances driven by NIH can have maximum effect on improving health. The committee supported viral pathogen research under the National Institute of Allergy and Infectious Diseases and noted that additional investments in BSL-4 infrastructure for research in highly pathogenic zoonotic viruses were critical.

Increasing diversity in biomedical research continues with the committee urging the National Institute of General Medical Sciences to expand its Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) program and the Minority Access to Research Careers undergraduate programs that train the next generation of scientists while enhancing diversity and enabling promising scientists to pursue high-risk, high-reward research. It also recognizes the importance of Institutional Development Awards (IDeA) to enhance the geographical representation across the NIH research portfolio and urged NIH to find ways to increase NIH IDeA state participation in major grant programs.

With regard for financial support for trainees and early-career researchers, the committee told NIH to evaluate the adequacy of compensation, including cost of living adjustments (COLAs), supported through fellowships, training grants, and research awards. The committee also wanted to see a report with an estimated budgetary need for instituting COLAs for postdoctoral students. NIH was also directed to provide a report on its full range of programs for early-career scientists and a budget to estimate the additional funding needed to grow and retain the early-career investigators pool, accelerate earlier research independence, and ensure the long-term sustainability of the biomedical research enterprise.

The National Institute of Aging was encouraged to increase support for research focused on mitigating immune dysfunction with precision-inspired therapeutics for Alzheimer’s and Alzheimer’s-related disorders (AD/ADRD), where the cost to treat and care for those suffering is expected to rise to $1.1 trillion per year without medical breakthroughs. The committee noted since FY 2025, research at NIH for AD/ADRD is the largest expenditure of its kind rising by more than 500 percent.

Barriers to research were addressed such as restrictions associated with Schedule I items of the Controlled Substance Act that make it difficult for researchers to access sources of marijuana following the National Institute on Drug Abuse (NIDA) report on such barriers.  NIDA was also encouraged to continue its investments in investigator-initiated grants in basic research and support training for young investigators.

NIH was also provided $135 million to support its efforts at building capacity to leverage artificial intelligence (AI), machine learning (ML), and data science to accelerate the pace of biomedical innovation. NIH review panels should also have more AI, ML, and data science expertise by working with the Center for Scientific Review to increase outreach to that community. Finally, the committee continued to support collaboration between NIH and the Department of Energy to bring together biomedical scientists with computer scientists, computational scientists, and other data science experts. The committee also requested an update within 180 days of enactment on NIH’s ethical standards related to biomedical research utilizing AI/ML.  NIH is also to support the Clinical and Translational Science Award program to catalyze opportunities in AI, big data, and other areas while training the next generation of physician-scientists.

On the topic of harassment, the committee was concerned by recent reports that despite being disciplined for sexual harassment against multiple trainees and co-investigators, NIH allowed the transfer of a principal investigator from one academic institution to another, where he continued to harass trainees, and was later awarded an additional $2.5 million NIH grant. The committee directs NIH to provide a full report of this incident, including an update on how NIH will rectify this particular case. In addition, NIH was directed to provide an update on how it intends to prevent enabling ‘‘pass the harasser’’ in the future and make clear to both institutions and researchers they will be held accountable, including through the loss of federal funding, for such incidents.

Another interesting area was the irreproducibility of many biomedical research studies or even outright fraud and the importance of detecting both reproducibility and fraud. NIH was provided $10 million to establish a program to fund replication experiments on significant lines of research, as well as attempts to proactively look for signs of academic fraud.