The House Energy and Commerce Health Subcommittee held a legislative hearing to consider 22 bills related to medical innovation, Food and Drug Administration (FDA) oversight, and clinical trials diversity on March 17.
The hearing was held as the subcommittee prepares legislation to reauthorize FDA user fee agreements (UFAs) that determine negotiated fees that drug and device makers pay to the FDA, which must be approved by Congress before the start of the new fiscal year on Sept. 30. The bills reviewed in the subcommittee hearing could be considered for attachment to this larger FDA package.
Among the bills under consideration was Chair Anna Eshoo’s (D-Calif.) Advanced Research Projects Agency for Health (ARPA-H) Act (H.R. 5585), to authorize President Joe Biden’s proposed medical research initiative. The subcommittee previously heard expert testimony on the existing proposals to authorize the program [refer to Washington Highlights, Feb. 11, Dec. 10, 2021], and all six witnesses at the March 17 hearing noted their support for the initiative.
Eshoo reiterated her proposal’s effort to establish ARPA-H within the Department of Health and Human Services but outside of the National Institutes of Health (NIH), noting that her preferred framework is “very clear … with the leadership in the House.” The Senate considered its ARPA-H authorization legislation, which would place ARPA-H within the NIH, during a March 15 markup of pandemic preparedness legislation [refer to related story]. The omnibus spending bill signed by the president on March 15 provides $1 billion for HHS to establish ARPA-H and allows the secretary to transfer the new entity to any agency within the department, including NIH, within 30 days of the bill’s enactment.
Full committee Ranking Member Cathy McMorris Rodgers (R-Wash.) expressed the importance of the overarching bipartisan effort to finalize user fee legislation on time, and also shared concern about the $1 billion appropriated for the ARPA-H initiative in the recently passed FY 2022 spending bill without companion authorizing legislation [refer to Washington Highlights, March 16]. “My concerns remain about accountability and the lack of a clear mission for ARPA-H. We should all want to make sure that money for research isn’t wasted but spent wisely for our shared goal for more cures,” McMorris Rodgers stated.
Members also discussed the Cures 2.0 Act (H.R. 6000), a broad bill aimed at increasing patient access to novel therapies led by Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) [refer to Washington Highlights, Nov. 19, 2021]. Discussions focused on the bill’s provisions on real-world evidence, antibiotic resistance, and digital technologies.
In response to questions from the subcommittee regarding legislation to increase clinical trials diversity, Ruben Mesa, MD, executive director of UT Health San Antonio MD Anderson Mays Cancer Center, commented on the importance of diversity in clinical trials and a patient-centered approach to trial design to better understand what it takes “to make [the trial] feasible for the patient.” He added that teamwork within the clinical care team and trustworthiness are key to take “great care of patients” and to “demystify” the treatment options, while utilization of telehealth can have a positive impact on diversifying participation in clinical trials.
Mesa, a cancer researcher, also highlighted the importance of federal investments for early career investigators as well as a strong workforce pipeline to enhance diversity in medical research.
Additional issues discussed in the hearing included legislation to address the FDA’s accelerated approval process and domestic drug manufacturing. Other participating witnesses included representatives from patient and FDA advocacy organizations and industry.