House and Senate Bills Would Provide Substantial Increase for NIH

Fiscal year (FY) 2019 came to an end on September 30 without Congressional passage of any of the 12 annual appropriations bills for FY 2020. As a result, Congress passed, and President Donald Trump signed into law, a continuing resolution (CR) that funds most federal agencies and programs at approximately last year’s funding levels through November 21, 2019.

Though the annual spending bills have not been finalized, both chambers have been making progress in this regard. The House of Representatives has passed 10 of its 12 bills, including the Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) appropriations bill that funds important agencies like NIH and CDC. The House bill, as previously reported includes a $2 billion increase for NIH for FY 2020. The Senate Appropriations Committee has approved 10 of its 12 bills but has not yet considered its Labor-HHS bill. Senate Labor-HHS Appropriations Subcommittee Chair (and 2017 AAI Public Service Awardee) Roy Blunt (R-MO) did, however, release a draft funding bill that includes a $3 billion increase for NIH for FY 2020. Although the bill has not been approved even at the subcommittee level, Chairman Blunt’s strong statement of support suggests that Senate appropriators could well push for an increase of up to $3 billion for NIH during final budget negotiations.

While a CR is far less damaging than a government shutdown, federal funding agencies – including NIH – are adversely impacted by them. Under a short-term CR, NIH typically sets conservative paylines, cuts non-competing research grant awards, and cannot start new programs.

Although Senator Richard Shelby (R-AL), Chair of the Senate Appropriations Committee, worked hard for the expeditious passage of appropriations bills throughout September, he acknowledged in a recent interview that a year-long CR would be likely if the Congress is unable to reach an agreement on border security. Such a CR would probably fund agencies at their previous year’s levels.

For the seventh consecutive year, AAI was a sponsor of, and participant in, the Rally for Medical Research Capitol Hill Day (“Rally Hill Day”). Rally Hill Day, which this year featured nearly 300 participants and had the support of about 350 organizations, brings together a wide range of NIH stakeholders, including medical researchers, clinicians, patient advocates, patients, and those working for the pharmaceutical and biotechnology industries, to advocate on Capitol Hill for increased funding for NIH.

AAI was represented by two members of the AAI Committee on Public Affairs: Peter Jensen, M.D. (AAI ‘87), ARUP Presidential Professor and Chair of the Department of Pathology at the University of Utah School of Medicine; and Joshua Obar, Ph.D. (AAI ‘04), Associate Professor in the Department of Microbiology and Immunology at the Geisel School of Medicine at Dartmouth. Dr. Jensen visited the Utah and Washington Congressional delegations in a group that also included AAI Director of Public Policy and Government Affairs Lauren Gross, J.D. Dr. Obar visited the Congressional delegations from New Hampshire and Vermont with AAI Manager of Science Policy and Legislative Affairs Jake Schumacher. Meeting participants expressed deep appreciation for recent NIH funding increases, including the $2 billion funding increase that the agency received for FY 2019. They also described the urgent need for continued robust funding increases to support vital research and researchers across the country and requested an increase of at least $2.5 billion for NIH (for a total budget of $41.6 billion) for FY 2020.

The AAI representatives also attended a congressional reception which featured remarks by a number of key leaders, including NIH Director Francis Collins, M.D., Ph.D., and Representatives Rosa DeLauro (D-CT, 3rd; 2013 AAI Public Service Awardee), Peter King (R-NY, 2nd), Jamie Raskin (D-MD, 8th), and Donna Shalala (D-FL, 27th). At the reception, Drs. Jensen and Obar had the opportunity to talk with Dr. Collins about their work and the importance of immunology. In conjunction with the event, AAI President Jeremy Boss, Ph.D. (AAI ’94), issued the following statement, which was featured on a sign at the reception:

“NIH funding has been essential to generations of immunologists working to better understand the immune system and how it can be utilized to prevent, treat, and cure disease. Extraordinary advances in immunotherapy, such as those recognized by the 2018 Nobel Prize in Physiology or Medicine, are allowing doctors to unleash patients’ own immune systems to fight cancer, transforming how we treat cancer and other diseases. NIH funding also supports urgently needed immunological research on infectious diseases (such as influenza, Ebola, and HIV/AIDS) and chronic diseases (such as Alzheimer’s disease, type 1 diabetes, and heart disease), saving lives, reducing pain, and preventing disability.”

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.

Following months of negotiations between key leaders in the White House and Congress, President Donald Trump signed into law today a sweeping budget deal that will facilitate the funding of federal government agencies and programs over the next two years. The two-year budget agreement lifts existing caps on both nondefense and defense discretionary spending (spending that Congress must appropriate annually) for fiscal year (FY) 2020 and FY 2021, and suspends the federal debt limit through July 31, 2021. The House approved the budget agreement by a vote of 284-149 on July 25th while the Senate approved it by a vote of 67-28 on August 1st.

Prior to this agreement, the statutory cap on nondefense discretionary (NDD) spending for FY 2020 was $542 billion, $55 billion below the FY 2019 level. Therefore, a failure to lift the cap would have required deep cuts across the NDD portfolio, potentially cutting the budgets of such key agencies as the National Institutes of Health (NIH), the National Science Foundation, and the Centers for Disease Control and Prevention. Fortunately, the budget deal lifts the FY 2020 NDD cap by $79.5 billion to $621.5 billion, an increase of $24.5 billion over FY 2019. This will provide Congress with the opportunity to make significant investments in priority areas, including NIH. The agreement also lifts the cap on NDD spending for FY 2021 to $626.5 billion, just $5 billion more than the new budget cap for FY 2020 but $71.5 billion above the previous FY 2020 budget cap. The caps on defense spending for FY 2020 and FY 2021 also rose significantly under the deal.

This new law enables Congress to complete work on the FY 2020 appropriations bills, including the Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) appropriations bill that funds NIH.

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.

AAI President JoAnne Flynn, Ph.D., submitted testimony to the Senate Finance Committee for its June 5 hearing on “Foreign Threats to Taxpayer-Funded Research: Oversight Opportunities and Policy Solutions.” While acknowledging concerns raised “by the NIH, this Committee, and press reports, among other sources, …about threats posed by foreign countries and foreign nationals to U.S. national security and U.S. intellectual property,” Dr. Flynn urged Congress, “before moving forward, …to understand fully the collaborative nature of science and the urgent need for international collaborations if the U.S. is to advance science, foster innovation, and remain the world’s leader in biomedical research.”

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