The Senate Labor, Health and Human Services, Education, and Related Agencies Appropriations Subcommittee (Labor-HHS) recently approved a Labor-HHS appropriations bill that includes a $2 billion (5.4 percent) funding increase for NIH for fiscal year (FY) 2019. The bill, which was approved by voice vote, was subsequently passed by the full Senate Appropriations Committee by a vote of 30-1. The House Labor-HHS Appropriations Subcommittee also recently approved (by voice vote) its FY 2019 Labor-HHS bill, which includes a $1.25 billion (3.4 percent) funding increase for NIH. The House Appropriations Committee later passed a modified version of the bill, which contains the same NIH funding level, on a party-line vote of 30-22.

Senate Bill

The Senate Labor-HHS appropriations bill was once again drafted by NIH champions and 2017 AAI Public Service Awardees Senators Roy Blunt (R-MO) and Patty Murray (D-WA), marking the third consecutive year that they were able to produce a bipartisan bill. This is also the fourth consecutive year that the subcommittee drafted a bill with a $2 billion funding increase for NIH, paving the way for large NIH funding increases in each of those years. The $2 billion increase included in the bill would bring the total NIH budget to $39.1 billion in FY 2019.

A significant portion of the NIH funding increase is directed to fighting certain diseases and funding specific programs. Some examples include:

* $711 million for the 21st Century Cures Act programs (the Beau Biden Cancer Moonshot, the Precision Medicine Initiative, the Brain Research Through Advancing Innovative Neurotechnologies Initiative, and a program supporting regenerative medicine)
* +$425 million for Alzheimer’s disease research
* +$37 million for research on combatting antibiotic resistant bacteria
* +$20 million for research toward developing a universal flu vaccine
* +$11.2 million for the Institutional Development Awards (IDeA) program

The Senate bill increases funding for most NIH Institutes and Centers (ICs) by at least 3 percent, including a 4.7 percent increase for the National Institute of Allergy and Infectious Diseases (NIAID), and a 3.1 percent increase for the National Cancer Institute (NCI). Because of the large influx of funding for Alzheimer’s disease research, the National Institute on Aging (NIA) receives a particularly large funding boost (+19.8 percent).

House Bill

The FY 2019 House Labor-HHS appropriations bill was drafted by House Labor-HHS Appropriations Subcommittee Chair Tom Cole (R-OK, 4th). The bill’s $1.25 billion increase for NIH would bring the total FY 2019 NIH budget to $38.3 billion. During consideration of the bill, Representative Cole expressed a desire to continue building on Congress’s recent funding increases for NIH, saying that he views the bill’s NIH funding level “as a floor, not a ceiling, for biomedical research funding, and ... hope[s] this number can increase as the process moves forward.” (For the past three years, Rep. Cole has in fact supported significantly larger increases in the NIH budget than have been approved by his subcommittee.)

An even larger percentage of the funding increase approved by the House is directed to specific priorities. NIH funding increases provided in the House bill include:

* $711 million for the 21st Century Cures Act initiatives
* +$401 million for Alzheimer’s disease research
* +$30 million to support work toward developing a universal flu vaccine
* +$15 million for research on combatting antibiotic resistant bacteria
* +$15 million for the Institutional Development Awards (IDeA) program

As a result of these directives, NIH ICs don’t fare particularly well in the House bill; many would receive increases of only about one percent. However, because of the large allocation for Alzheimer’s disease research, NIA would still see a budget increase of 16.8 percent.

Looking Ahead

While the House and Senate bills have been cleared at the committee level, neither bill has been considered by the full House or Senate. Once the House and Senate have passed their own bills, they must develop a joint Labor-HHS bill that gets approved by both chambers of Congress and is signed into law by President Trump.

Congress has until the end of the fiscal year (September 30, 2018) to complete work on its annual appropriations bills and ensure that they are signed into law by the president. If the Labor-HHS appropriations bill is not signed into law by that time, Congress will need to approve a continuing resolution to fund the bill’s programs, quite possibly until after the November elections.

Senate Labor-HHS Appropriations Bill Summary

House Labor-HHS Appropriations Bill Summary

On July 18, AAI cosponsored, and participated in, the inaugural Celebrate Life Sciences Fair and reception on Capitol Hill. The event, which was hosted by The Coalition for the Life Sciences (CLS) and the Federation of American Societies for Experimental Biology (FASEB), highlighted the importance of federal investment in medical research and how advances in biomedical research improve human health.

Former AAI Public Policy Fellow Michael Constantinides, Ph.D. (AAI ‘13), AAI Director of Public Policy and Government Affairs Lauren Gross, J.D., AAI Manager of Science Policy and Legislative Affairs Jake Schumacher, and AAI Science Policy Analyst Lauren Brodd, Ph.D., provided attendees with information about the importance of the immune system and discussed recent immunologic advances, including in immunotherapy. A total of 10 organizations, including AAI, sponsored exhibits at the Fair, while about 150 people, including several members of Congress and numerous Congressional staffers, attended the event.

During the June meeting of the NIH Advisory Committee to the Director (ACD), the ACD Working Group on the NGRI presented its interim report. The Working Group, which is charged with providing “advice on the development, implementation, and analysis of the Next Gen policy to increase the number of NIH-funded ESIs [Early Stage Investigators] and EEIs [Early Established Investigators] and stabilize the career trajectory of scientists,” made several draft recommendations:

* Revise the original NGRI definitions
* Develop methods to support ESIs and “at-risk” investigators
* Enhance ESI diversity
* Optimize workforce stability
* Assess productivity using a multifaceted approach

In terms of modifying the original NGRI definitions, the Working Group believes that the definitions of ESIs and EEIs would not capture enough of the investigators in need and therefore should be broadened to increase flexibility. Possibilities include modifying the ESI status, originally defined as within 10 years of receiving a terminal degree, to 15 years, or to approximately six years after the date of one’s first independent position. Rather than targeting EEIs, defined as within 10 years of receiving an R01-equivalent award, the Working Group may recommend focusing on meritorious investigators across all career stages who are at risk of losing all funding.

The Working Group will consider input from stakeholders as it develops final recommendations, which will be presented at the December 2018 ACD meeting.

Along with stakeholder input, the Working Group will also consider recommendations directed to NIH in a recently-released report by The National Academies of Science, Engineering, and Medicine (NASEM), entitled “The Next Generation of Biomedical and Behavioral Researchers: Breaking Through.” The report, which was mandated by Congress in 2016, was issued following an 18-month study by a NASEM ad hoc committee (Committee on the Next Generation Researchers Initiative) to “examine the policy and programmatic steps that the nation can undertake to ensure the successful launch and sustainment of careers among the next generation of researchers....”

The full report recommends ways, including the following, that Congress, the NIH, research institutions, and principal investigators (PIs) can help sustain the biomedical research enterprise:

* Congress should establish a Biomedical Research Enterprise Council (public-private partnership of stakeholders to oversee implementation and ensure accountability).
* NIH should implement a three-year cap on postdoctoral researcher salary support from a PI’s research grant, as well as a five-year cap for total postdoctoral training.
* NIH should expand five-fold the number of individual research fellowship and career development awards.
* Institutions should implement a $1,000 annual fee on PIs for each postdoc supported on a research grant (for a mentorship and career guidance fund).

Presentation by NIH ACD Working Group

AAI recently submitted comments in response to a Request for Information (RFI) by NIH entitled “Animal Care and Use in Research” (Notice NOT-OD-18-152). The RFI was issued because of a provision in the 21st Century Cures Act that requires NIH, FDA, and the United States Department of Agriculture (USDA), to revise regulations and policies relating to the use of animals in research in order to reduce burden on investigators, while maintaining the protection of laboratory animals.

AAI agrees with several of the actions NIH proposes to reduce burden on investigators; these include allowing investigators to submit protocols for review using a risk-based methodology and using the same schedule for annual reporting to the Office of Laboratory Animal Welfare (OLAW) and USDA. AAI also makes additional recommendations not specifically mentioned in the RFI, including changing the Institutional Animal Care and Use Committee (IACUC) review time frame from the current three years to five years in order to match the time frame of most R01 grants.

AAI Response to NIH RFI on Reducing Burden in Animal Research

A new report from The National Academies of Science, Engineering, and Medicine (NASEM) has found sexual harassment of women to be “common” in science, engineering, and medicine. The report, entitled “Sexual Harassment of Women: Climate, Culture, and Consequences in Academic Science, Engineering, and Medicine,” finds “that the cumulative result of sexual harassment is significant damage to research integrity and a costly loss of talent in these academic fields.” Further, the report “urges institutions to consider sexual harassment equally important as research misconduct in terms of its effect on the integrity of research.”

The topic of sexual harassment was also discussed at the June meeting of the NIH Advisory Committee to the Director (ACD) by NIH Principal Deputy Director Lawrence Tabak, D.D.S., Ph.D. His presentation covered both the extramural and intramural workforce. Regarding the extramural community, Dr. Tabak reminded the ACD that NIH awards grants to institutions, not their employees, and awardees are responsible for those individual employees. He also emphasized the previously published NIH Notice relating to Title IX (Notice NOT-OD-15-152) and the NIH Notice regarding the institutional obligation to inform NIH about a change in investigator status (Notice NOT-OD-18-172). With respect to the intramural community, NIH has established an NIH Anti-Harassment Steering Committee that will oversee efforts to strengthen anti-harassment activities, such as updating reporting tools and policies and completing an NIH Workplace Climate and Harassment Survey.

ACD Presentation on NIH Sexual Harassment Policies and Procedures