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House Subcommittee Approves Draft User Fee, ARPA-H Authorizing Bills

May 13, 2022

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The House Energy and Commerce Health Subcommittee advanced several bills May 11 [refer to related story], including legislation for the Food and Drug Administration (FDA) to collect user fees from developers of medical products and legislation authorizing the creation of the Advanced Research Projects Agency for Health (ARPA-H).

The panel approved subcommittee chair Anna Eshoo’s (D-Calif.) ARPA-H Act (H.R. 5585) by voice vote following minimal debate on the bill. The legislation would make ARPA-H a new entity within the Department of Health and Human Services (HHS) — independent of the National Institutes of Health (NIH) — and would formulate guidelines for the establishment of the new research entity and its staffing [refer to Washington Highlights, March 18].

In her opening statement, full committee ranking member Cathy McMorris Rodgers (R-Wash.) addressed ARPA-H, noting, “I have raised concerns about its duplication, lack of accountability, and unclear priorities and mission. We should all want to make sure money for research isn’t wasted but spent wisely for results and more cures.” She added that she hoped a substitute amendment that could garner more bipartisan support would be ready to introduce at the full committee markup.

The Senate Health, Education, Labor, and Pensions (HELP) Committee on March 15 advanced its bill to establish ARPA-H as an independent entity within NIH, the Advanced Research Project Authority for Health Act (S. 3819) [refer to Washington Highlights, March 18].

Full committee chair Frank Pallone (D-N.J.) addressed the absence of the Cures 2.0 Act (H.R. 6000) from the markup, following a prior commitment from committee leaders to move it alongside the ARPA-H Act [refer to Washington Highlights, Feb. 11]. “While CURES 2.0 was not noticed as part of today's markup, I'm pleased to say that we've made progress on several of the priorities included in the bill. … We are also going to continue to seek technical assistance from the Administration and work on a bipartisan basis to advance the rest of the CURES 2.0 legislation,” Pallone said.

The subcommittee also approved Eshoo’s amendment in the nature of a substitute to H.R. 7667, the Food and Drug Amendments of 2022. The draft bill includes bipartisan agreements on the FDA user fees for drugs, devices, generic drugs, and biologics, as well as additional provisions related to the FDA’s accelerated approval pathway, diversity in clinical trials, the use of animal testing alternatives, and others.

The user fee package would also require the FDA’s Medical Devices Advisory Committee to convene at least yearly and to provide advice to the HHS secretary on relevant topics including in vitro diagnostics. During the markup, Rep. Larry Bucshon, MD, (R-Ind.) expressed his disappointment that the legislation did not include additional provisions to address FDA oversight of laboratory-developed tests, as included in his Verifying Accurate, Leading-Edge IVCT Development Act (H.R. 4128) [refer to Washington Highlights, June 25, 2021].

The bills advanced by the subcommittee on May 11 are expected to be considered by the full Energy and Commerce Committee during the week of May 16. The Senate HELP Committee is also expected to begin consideration of its own comparable legislation in the coming weeks. The user fee bill is considered “must pass” legislation in advance of the current law’s expiration on Sept. 30.

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