House and Senate Bills Would Provide Substantial Increase for NIH

Nearly three months into fiscal year (FY) 2020, Congressional leaders and the White House announced in December that they had reached an agreement on appropriations bills for fiscal year (FY) 2020. Per the agreement, the funding bills were divided in into two packages, including an 8-bill package that funds the Department of Health and Human Services, among many other departments and agencies. That 8-bill package, or “minibus,” includes an increase of $2.6 billion for the National Institutes of Health (NIH). The minibus was approved by the House 297-120 on December 17, by the Senate 71-23 on December 19, and signed into law by President Donald Trump on December 20.

FY 2020 began on October 1, 2019, with federal government agencies and programs roughly flat-funded under a continuing resolution (CR) that lasted through November 21. As lawmakers pushed up against that deadline, a second CR was enacted, funding the federal government through December 20. Appropriators worked behind the scenes to complete work on appropriations before the second deadline in December in order to avert a potential government shutdown or a third CR that could have delayed the completion of appropriations bills indefinitely. Fortunately, they were able to reach an agreement that satisfied key leaders in the House, Senate, and White House.

The new appropriations law includes a total appropriation of $41.7 billion for NIH for FY 2020, an increase of $2.6 billion (6.6 percent). Thanks to remarkable Congressional support, the NIH budget has now increased by $11.6 billion (39 percent) over the past five years.

All NIH Institutes and Centers will receive an increase of at least 3.3 percent under the new law. Some other notable NIH budget increases include:
• $350 million for Alzheimer’s disease research (total of $2.82 billion)
• $225 million for buildings and facilities to address a backlog of maintenance issues identified in a National Academies report last August (total of $425 million)
• $161 million for the All of Us precision medicine cohort study (total of $500 million)
• $71 million for the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) initiative (total of $500 million)
• $60 million to develop a universal influenza vaccine (total of $200 million)
• $50 million for the Combatting Antibiotic Resistant Bacteria program (total of $600 million)

Many other public health and science agencies also received funding increases in the new appropriations law. For example, the Centers for Disease Control and Prevention received a increase of about $636 million, for a total budget of about $8 billion. The Food and Drug Administration (FDA) will see a smaller budget boost, received a $91 million increase in discretionary funding for a $3.16 billion total appropriation from Congress (including mandatory funding and user fees, the overall FDA budget will be $5.77 billion). At the United States Department of Agriculture (USDA, the intramural Agricultural Research Service actually received a budget cut of $77 million (4.6 percent), while the Agriculture and Food Research Initiative, the competitive research grant program at USDA received an increase of $10 million (2.4 percent).

AAI advocated strongly for an NIH budget increase of at least $2.5 billion for FY 2020, including through congressional testimony, several Capitol Hill days, and sign-on letters. Leading up the final vote on the FY 2020 appropriations bill, AAI encouraged its members to urge their lawmakers to support the minibus that provided a $2.6 billion increase for NIH.

Members of the AAI Council recently visited Capitol Hill to describe the importance of immunology research and to urge their Members of Congress to increase funding for NIH. Council Hill Day participants visited a total of 18 congressional offices, where they asked Members of Congress and their staffs to support an NIH budget increase of at least $2.5 billion for FY 2020, for a total budget of $41.6 billion. They also urged the rapid passage of the FY 2020 Labor-HHS appropriations bill (which funds NIH), explaining the damage caused by continuing resolutions (CRs) to the agency, to researchers, and to the broader research enterprise. These visits were particularly well-timed, with Council Hill Day taking place just two weeks before the December 20 expiration of the 2nd CR, and as Congress worked behind-the-scenes to reach a final appropriations agreement.

The AAI Council also had the opportunity to present the AAI Public Service Award (PSA) to three Members of Congress. Former AAI President JoAnne L. Flynn, Ph.D., presented the 2018 PSA to Representative Tom Cole (R-OK, 4^th), the Ranking Member and former Chair of the House Labor, Health and Human Services, Education, and Related Agencies Subcommittee. Representative Cole generously welcomed all Council Hill Day participants into his office, described his strong support of biomedical research, and assured Council that he is fighting for another significant NIH funding increase for FY 2020. AAI President Jeremy M. Boss, Ph.D., presented both 2019 PSAs to NIH champions Representative Nita Lowey (D-17^th, NY) and Senator Richard Shelby (R-AL), who chair the Appropriations Committee in their respective chambers. Representative Lowey, who recently announced her impending retirement, welcomed Council into the U.S. Capitol Building for the award presentation and expressed deep appreciation for both the work that immunologists do and the award honor. Although Senator Shelby was unable to receive the award personally, Dr. Boss presented the PSA to a member of his staff, with whom presentation attendees had an excellent conversation.

In addition to Drs. Boss and Flynn, Council members participating in Hill Day were AAI Secretary Treasurer Edith Lord, Ph.D.; AAI Councillors Gary Koretzky, M.D., Ph.D., Akiko Iwasaki, Ph.D., and Stephen Jameson, Ph.D.; and, AAI ex officio members Eugene Oltz, Ph.D., Editor-in-Chief of The Journal of Immunology, and M. Michele Hogan, Ph.D., AAI Executive Director. They were joined by AAI Committee on Public Affairs Chair Ross Kedl, Ph.D.; 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.

During last week’s NIH Advisory Committee to the Director (ACD) meeting, the ACD discussed several important issues. The ACD Working Group on Changing the Culture to End Sexual Harassment, which was established in 2018, issued its final report. During the presentation, the Working Group provided an update on NIH actions related to this topic and made many recommendations to NIH, NIH-funded institutions, and scientific and professional societies, which were described under four overarching themes:
• “Increase Transparency and Accountability in Reporting of Professional Misconduct, especially Sexual Harassment
• Establish Mechanisms for Restorative Justice
• Ensure Safe, Diverse, and Inclusive Research and Training Environments
• Create System-wide Change to Ensure Safe, Diverse, and Inclusive Research Environments.”

During the meeting, the ACD members voted to accept the Working Group’s recommendations. As NIH Director Francis Collins, M.D., Ph.D., explained in a post on his Director’s blog following the meeting, he is “supportive of these solid recommendations” and indicated that NIH has already been working to implement some of the recommendations, including establishing a mechanism for reporting and developing standard operating procedures for actions taken after an allegation is received. NIH also plans to work to implement additional recommendations.

Other presentations of interest include updates from four additional ACD Working Groups: Next Generation Researchers Initiative, Foreign Influences on Research Integrity, Diversity, and Enhancing Reproducibility and Rigor in Animal Research.

ACD meetings are open to the public, and slide presentations are available on the ACD website. The archived webcast will soon be available here.

President Trump signed an Executive Order (EO) in September on “Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health.” While emphasizing that vaccination is the most effective way to prevent seasonal influenza, the EO describes improving influenza vaccines as a “public health and national security priority, as influenza has the potential to significantly harm the United States and our interests, including through largescale illness and death, disruption to military operations, and damage to the economy.”

The EO lists several objectives, including to reduce the use of egg-based influenza vaccine production and to develop more broadly protective vaccines with more effective and durable immunity. To create a plan to achieve the objectives as well as to monitor implementation, the EO establishes a National Influenza Task Force, which will be co-chaired by the Secretary of Health and Human Services and the Secretary of Defense and will be comprised of senior officials from several federal departments and agencies, including NIH, the Centers for Disease Control and Prevention, the Food and Drug Administration, the Department of Agriculture, and the Department of Defense, and the Department of Homeland Security. The task force must produce a report by January 2020 that includes:

* “a 5-year national plan to promote the use of more agile and scalable vaccine manufacturing technologies and to accelerate development of vaccines that protect against many or all influenza viruses;
* recommendations for encouraging non-profit, academic, and private sector influenza vaccine innovation; and
* recommendations for increasing influenza vaccination among the populations recommended by the CDC and for improving public understanding of influenza risk and informed influenza vaccine decision-making.”

The task force will also provide yearly progress reports, with revised recommendations if needed, to achieve the plan’s objectives.

The U.S. Department of Health and Human Services (HHS) recently announced policy changes for research involving human fetal tissue obtained from elective abortions. The changes were announced in a June 5 statement and will effectively end this type of research within the NIH intramural program by prohibiting NIH from acquiring such new fetal tissue. For the extramural community, the policy created an additional layer of review by an ethics advisory board for new and competitive renewal grant applications involving this type of tissue.

To implement this new policy, NIH released a Notice of “Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research” (Notice number NOT-OD-19-128) in late July, effective for grant applications with due dates on or after September 25 that involve human fetal tissue obtained from elective abortions (HFT). NIH will require applicants to provide “a justification of the use of HFT, details regarding procurement and costs, and information about how the applicant/contract offeror will use HFT.” The Notice states that these “additional requirements must be met within existing applicable page limits” and should be “sufficiently detailed to permit meaningful evaluation by NIH.” Modular budgets cannot be used for applications using HFT, and training awards and fellowships may not propose this type of research. The Notice also explains that applications with fundable scores will be reviewed by an ethics advisory board comprised of scientists and bio-ethicists, among others, that will assess whether the research is in compliance with NIH policy and recommend to NIH applications that should be funded.

Following the HHS announcement, AAI signed a community letter, organized by the International Society for Stem Cell Research, which was sent to HHS Secretary Alex Azar, J.D. The letter, which was co-signed by more than 90 organizations, expressed opposition to this new HHS policy because it “would impose substantial barriers to and limit the use of an essential biomedical research resource that has led to many advances in human health and remains critical for the development of new treatments for a wide range of serious diseases.”

In addition, AAI signed a community letter thanking Representative Mark Pocan (D-WI, 2nd) and cosponsors of his amendment to block the implementation of the new HHS fetal tissue policy. That amendment was adopted as part of the FY 2020 House Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) appropriations bill. The Senate has not yet considered its FY 2020 Labor-HHS bill, so it remains unclear whether this language will be included in the final legislation.