Inside (the Beltway) ScoopBy: Ellen Kuo
Thursday, February 24, 2022
Continuing Resolution Keeps Government Operating and ARPA-H Is Scrutinized
Congress passed a third continuing resolution, H.R. 6617, Further Additional Extending Government Funding Act (P.L. 117-86), on Friday, February 18, which the president signed into law. This will keep the government operating until March 11as work on the fiscal year (FY) 2022 funding bills continues.
Earlier this month, the House Energy and Commerce’s Health Subcommittee held a hearing on the Advanced Research Projects Agency for Health (ARPA-H), titled ARPA-H: The Next Frontier of Biomedical Research. Chair Anna Eshoo (D-CA) announced her intention to move her legislation to mark-up quickly. During the hearing, her top legislative priority was viewed as complementary to the work of Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) on Cures 2.0, which was unveiled in June 2021. Theirs is a follow on to the 21st Century Cures Act to involve patients and their families in modernizing coverage and access to life-saving cures in the United States and across the globe. Cures 2.0 would use digital health delivery and harness data to empower patients to improve their health with increased health literacy and information about their options for treatment and services.
At the hearing, questions were asked related to transparency, accountability, reform of the National Institutes of Health (NIH), and other agency authorities. On the topic of its structure, witnesses testified that ARPA-H would be different from other programs and agencies because of its sense of urgency from the bottom to the top. Witnesses noted it should have an increased level of transparency and accountability to Congress and the U.S. Department of Health and Human Services. They also said it needs end-to-end engagement of all relevant stakeholders to ensure ease of translation to patients.
Most witnesses supported ARPA-H being housed outside of NIH in order to have independence and establish a completely different culture than NIH. This culture would encourage risks by de-risking research at every phase of a project to incentivize novel approaches and allow for the quick termination of program managers and projects that are not achieving milestones. Fulfilling the need to bring breakthroughs in health to patients quickly with new platforms that would support many disease areas or significantly improve imaging technologies would be major goals for ARPA-H. Authorizing this new agency and then funding it appropriately over multiple years is part of the thinking. House appropriators considered funding it for FY 2022 at $3 billion and the Senate for $2.5 billion. However, a final decision regarding funding has not been made.
On another note, NIH, which did not have a representative at the hearing, received criticism related to being unresponsive to Congressional requests. Additionally, it was suggested that NIH should find ways to reduce burden on researchers by reducing their paperwork. FASEB will provide updates as the ARPA-H legislation moves through the legislative process.