2020 Year-End Research and Public Health Funding Advocacy Highlights

During 2020, ASH continued to be highly visible in our advocacy for federal support of biomedical research and public health funding, including funding for the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). ASH and other members of the biomedical research community have strongly urged Congress to provide increased funding for NIH and CDC, noting the increased resources needed by these agencies due to the COVID-19 pandemic.

The research and public health community’s message is being heard. Appropriations legislation passed in the House in July 2020 provides $42 billion in annual appropriations for the NIH in fiscal year (FY) 2021, a $500 million increase over the agency’s current funding level, as well as an additional $5 billion in emergency appropriations for NIH to be used to offset costs related to reductions in laboratory productivity resulting from COVID-19-interruptions or shutdowns of research. The bill also provides $8 billion for the CDC, an increase of $232 million above FY 2020 levels, as well as $9 billion in emergency supplemental appropriations for CDC to improve the nation’s preparedness for public health emergencies. Additionally, an ASH-supported amendment the House-passed bill provides $2 million for the CDC’s Sickle Cell Data Collection (SCDC) Program authorized by the Sickle Cell Disease Research, Surveillance, Prevention, and Treatment Act of 2018 (Public Law 115-327).

While the Senate did not consider of any of its spending bills before the start of the new fiscal year on October 1, 2020, the Senate Appropriations Committee did release draft versions of its bills on November 10, 2020. The bills are unlikely to ever be considered by the full Senate but will be used as a starting point for negotiations on an omnibus spending bill with House negotiators. The Senate proposal seeks $43.68 billion in annual funding for NIH, a $2 billion increase of over FY 2020 levels, and $6.9 billion for the CDC, an increase of $68.5 million over the previous fiscal year.

Because Congress was not able to finalize any of its FY 2021 spending bills by the start of the fiscal year, the federal government – including NIH and CDC – have been operating under a continuing resolution or “CR,” which prevented a government shutdown and extended FY 2020 funding for federal agencies and programs through December 11, 2020. Congressional leaders are continuing negotiations to reach an agreement on spending levels for all federal government agencies that may also include COVID-19 stimulus and emergency spending provisions. However, because it is unlikely that an agreement will be reached prior to the expiration of the current CR, Congress will be forced to pass another CR that lasts until later in December to prevent a government shutdown and allow time for a final agreement to be reached, voted on, and signed into law.

Below are some of the highlights of the Society’s 2020 advocacy efforts in support of research and public health funding.

COVID-19

• ASH has continuously advocated for additional funding for NIH and other federal public health programs for efforts related to the COVID-19 pandemic.
  • The Coronavirus Aid, Relief, and Economic Security (CARES) Act (H.R. 748) that passed the Senate via unanimous vote on March 25, 2020 and approved by the House of Representatives by a voice vote on March 27, 2020, was quickly signed into law by the President. The package included $4.3 billion in emergency funding for CDC and $945 million for NIH to support research to expand on prior research plans related to COVID-19.
  • In April 2020, ASH lent its support to Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) for a congressional sign-on letter urging House leaders to include $26 billion in the next COVID-19 relief package for the NIH. ASH sent a message to its Grassroots Network members to contact their Members of Congress to back this initiative.
  • The Society joined numerous other organizations in sending letters to House and Senate leaders seeking additional funding for NIH to address COVID-19-related disruptions to research.
  • ASH joined other organizations in seeking funding for COVID-19 research efforts at the National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
  • ASH supported the introduction of H.R. 7308 and S.4286, the Research Investment to Spark the Economy Act (RISE) Act, which authorizes approximately $26 billion in supplemental funding for federal research agencies, including NIH, to mitigate the disruption to federally funded research caused by the COVID-19 pandemic.
  • ASH signed on to a letter to congressional leaders supporting $50 million for the Agency for Healthcare Research and Quality (AHRQ) to generate data needed to make an informed decision about which telehealth flexibilities Congress and the Administration should make permanent.
• ASH leadership met with institute directors and staff at NHLBI, NIDDK, and NCI to provide information and updates on ASH’s COVID-19 Research Agenda for Hematology; the ASH Research Collaborative’s (RC) COVID-19 Registry for Hematology; concerns about research restart issues; and ASH’s minority recruitment efforts.
• As part of ASH’s work with the U.S. Food and Drug Administration (FDA) and other partners to address the significant challenges of maintaining the national blood supply during the pandemic, the Society issued a statement in support of the FDA’s updated guidance to expand blood donor eligibility guidelines to address the pressing need for blood donations during the pandemic.

Grassroots Advocacy Campaigns

• ASH developed several on-line advocacy campaigns for all Grassroots Network members to join in an effort to urge Congress to support federal medical research and public health program funding. Members may visit the ASH Advocacy Center to find sample letters supporting funding for NIH and CDC, including funding for sickle cell data collection efforts at CDC. They can then enter their contact information, and the site will send the letter directly to their Representative and Senators. Information is also included about how to contact Members of Congress via phone or engage via Twitter. During the past year, members of the ASH Grassroots Network sent more than 900 messages to Capitol Hill in support of ASH’s policy priorities, including NIH and public health funding.

Hill Days and Congressional Visits

• While this year looked a little different, it remains true that one of the most visible ways for the Society to advocate for hematology issues is through meetings with Members of Congress and their staff in Washington, DC. This year ASH hosted its first virtual Hill Event. During the week of September 21–25, ASH hosted over 50 virtual meetings with Members of Congress and their staff to advocate for several issues of importance to hematology, including funding for NIH, a plea to make permanent the telemedicine changes that were granted under the COVID-19 pandemic, and policy issues impacting sickle cell disease (SCD). The participants included members of the Committee on Government Affairs and Committee on Practice and participants from the previous 10 years of the ASH Advocacy Leadership Institute. ASH staff and members of the Society also held numerous additional meetings with congressional offices throughout the year to advocate for the Society’s policy priorities.

Testimony

• Earlier this year, during hearings concerning the FY 2021 federal budget, ASH submitted written testimony to the House and Senate Appropriations Committees supporting funding for NIH and CDC, including additional funding for efforts related to COVID-19,and urging the committees to recognize the progress and potential future advances shown by hematology research. 

Coalition Activities

• ASH continues to work with the Coalition for Health Funding (CHF), the Ad Hoc Group for Medical Research, Research!America, and members of the biomedical research and public health communities to advocate on behalf of NIH and public health program funding. As part of this effort, ASH was once again a sponsor of and participant in the annual Rally for Medical Research Hill Day, which was held virtually on September 17. Patient advocates, caregivers, researchers and health professionals from more than 300 partnering organizations met with House and Senate offices to call on our nation's policymakers to make funding for the NIH a priority and raise awareness about the importance of continued investment in scientific research.

Additional Research Advocacy

• Work with the FDA: ASH continued to work closely with the FDA throughout 2020 on issues impacting the approval of hematologic drugs and therapies, as well as issues related to safety and supply.
  • In October, ASH submitted a letter to the FDA in response to its Draft Guidance for Industry: Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment. The draft guidance included the FDA’s current thinking on clinical trial design issues related to the development of treatments for acute myeloid leukemia in several areas, with recommendations for considerations for curative versus noncurative therapies, exploratory versus confirmatory trials, and so on. ASH’s response was supportive of the provisions in the guidance, and ASH requested clarification of several sections.
  • In May, ASH provided comments in support of the FDA’s Draft Guidance for Industry - Inclusion of Older Adults in Cancer Clinical Trials, noting that there are a number of hematologic malignancies prevalent among the elderly and by increasing enrollment of older patients in trials, trial outcomes will reflect the real-world patient population.

• Fetal Tissue Research: ASH continued to work with members of the scientific, academic, and patient communities to address the restrictions on research involving the use of human fetal tissue that were announced by the Department of Health and Human Services (HHS) in June 2019.
  • ASH joined nearly 100 organizations from the medical and scientific communities involved in fighting the COVID-19 pandemic to send a letter in March 2020 urging President Trump to “consider the potential of fetal tissue research to accelerate an end [to] the pandemic, reduce human suffering, and enable the U.S. to respond to future public health threats” and to lift the restrictions on research using human fetal tissue funded by the NIH.
  • ASH also supported legislation (H.R. 6417, the Protecting Cures Act of 2020) introduced on March 31, 2020, by Representatives Jan Schakowsky (D-IL) and Mark Pocan (D-WI) that seeks to remove the current restrictions on research involving fetal tissue and to enact guardrails to protect this biomedical research moving forward.
  • In July, ASH signed a letter from the research community to the NIH Human Fetal Tissue Research Ethics Advisory Board prior to its first meeting on July 31, 2020. The Ethics Advisory Board, which was created as part of the new policies on research using human fetal tissue announced by HHS in June 2019, is tasked with providing an additional layer of review following the peer review process for research grant applications involving the use of human fetal tissue.
  • Following the August 18 release of the Board’s report that recommended proceeding with funding only one of the 14 grant applications it had reviewed, ASH signed a letter with more than 75 other research organizations to HHS Secretary Alex Azar urging him to reject the Ethics Advisory Board’s recommendation to block funding for specific research projects and to immediately revoke the HHS policy restricting federal funding for biomedical research involving fetal tissue.

Additional materials, comment letters, and testimony concerning ASH advocacy related to research issues and NIH funding can be found on the ASH website.