The House Energy and Commerce subcommittee on health convened experts from academic medicine, biotechnology, and public health for a Dec. 8 hearing on the future of biomedical research.
In their opening statements, Committee Chair Frank Pallone (D-N.J.), Ranking Member Cathy McMorris Rodgers (R-Wash.), and Subcommittee Chair Anna Eshoo (D-Calif.) highlighted advances in biomedicine in the last 20 years, specifically spurred by the Human Genome Project and passage of the 21st Century Cures Act (P.L. 114-255). Throughout the hearing, members looked ahead to future opportunities and asked witnesses how Congress can best support biomedical research and facilitate faster translation of basic research into better health for patients.
Stanford University School of Medicine Dean Lloyd B. Minor, MD, provided specific examples of the translation of findings into improved patient care, and added that the university is encouraged by the Advanced Research Projects Agency for Health (ARPA-H) proposal that recognizes “the critical importance of our country’s biomedical enterprise and reflects our aspirations to move discoveries from lab bench to bedside.”
The ARPA-H proposal, first introduced by President Joe Biden, is included in two pieces of authorizing legislation introduced in the House of Representatives — H.R. 5585, the Advanced Research Project Agency-Health Act introduced by Eshoo [refer to Washington Highlights, Oct. 22], and H.R. 6000, the Cures 2.0 Act introduced by Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) [refer to Washington Highlights, Nov. 19].
During the hearing, several Democratic members asked witnesses how Congress should invest to accelerate research progress. Minor testified that efforts to encourage innovation and entrepreneurship would complement the National Institutes of Health’s (NIH’s) work of funding research. He added that incentivizing public-private partnerships and investing in NIH training grants to support the training of the next generation of research leaders would be beneficial to further support translating research findings to cures.
Rep. John Curtis (R-Utah) countered this line of questioning by asking what actions the federal government might take that could harm the existing research enterprise. Minor replied that federal regulations have the potential to impede the speed to patient delivery, noting that better coordination between the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention could be beneficial.
Members also addressed difficulties in data collection and sharing, particularly between state and federal public and private partners. Atul Butte, MD, PhD, distinguished professor and director of the Bakar Computational Health Sciences Institute at the University of California, San Francisco and chief data scientist at the University of California Health stated that “collecting more data isn’t just the challenge. Making sure we collect data in a fair, responsible, and transparent way, and ensuring the data collected properly represents all our patients is of utmost importance.”
Rep. Buddy Carter (R-Ga.) discussed China’s ongoing efforts to increase genomics research. Amy Abernethy, MD, PhD, president of clinical studies platforms at Verily and former principal deputy commissioner at the FDA, and Leroy Hood, MD, PhD, CEO of Phenome Health, testified that continued strong investments in research domestically would be important to maintaining the U.S.’s global competitiveness.
Lawmakers also addressed the need to improve diversity in clinical trials. Adolph P. Falcón, MPP, executive vice president of the National Alliance for Hispanic Health, added that the shift to decentralized clinical trials creates additional barriers for those without access to technology or additional financial support for costs associated with their participation in a trial.
Falcón urged Congress to consider mandating inclusion of community-based, participatory research standards as part of FDA review of new drugs, as well as in NIH grant proposals to enhance inclusion of minority participants in advancing medical research.
Lawmakers also addressed outcomes of the 21st Century Cures Act, including the FDA’s required assessment of real-world data and real-world evidence in its clinical decision-making. Upton also asked witnesses about opportunities to speed up the Centers for Medicare & Medicaid Services’ (CMS’) payment decisions for FDA-approved medications. Abernethy suggested working to ensure the CMS has confidence in the FDA’s approved datasets to leverage the same data for both FDA and CMS approvals.
In advance of the hearing, Eshoo told reporters that, in the new year, the subcommittee would hold a legislative hearing on the Cures 2.0 Act that aims to build upon the 21st Century Cures Act and that she hoped to “try to get [the bill] done in this Congress.”