House Subcommittee Takes First Steps in Passing FDA User Fee Legislation

By Jennifer Dexter, NHC Assistant Vice President, Policy

On May 11, the House Energy and Commerce Health Subcommittee unanimously passed H.R. 7667, the Food and Drug Amendments of 2022. This legislation codifies the user fee agreements transmitted to Congress by the Food and Drug Administration (FDA) as well as additional legislation that Congress has attached to the bill. The vote was preceded by significant bipartisan support for the legislation as well as commitments to continue to address outstanding issues as the bill moves to full Committee next week. One outstanding issue is legislation to address the future of the orphan drug tax credit and other priorities of the Congressional Rare Disease Caucus. This is a priority for the NHC and several of our members.

The National Health Council (NHC) is supportive of the agreement and has commented on both the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA). Specifically, NHC has supported provisions of both agreements that address the incorporation of patients’ perspectives in medical product development and FDA decision-making, increasing use of real-world evidence, and increasing the use of digital health tools in care and research.

In addition to the user fee legislation, the Committee also passed H.R. 5585, the Advanced Research Project Agency-Health (ARPA-H) Act. The legislation would authorize the creation of ARPA-H, a new federal entity designed to increase investment in health research and to drive transformational innovation in health research and speed application and implementation of health breakthroughs. The NHC has provided significant input to assure that this new entity will support breakthroughs that will best benefit people with chronic conditions.

This legislation will now move to the full Energy and Commerce Committee for markup before ultimately being considered by the full House of Representatives. The Senate Health, Education, Labor, and Pensions Committee is expected to consider their version of legislation in the near future. The NHC will continue to work with our members to understand their perspectives on the various provisions included in the bills and work with Congress to ensure timely passage of the user fee reauthorization.

For more information about the NHC’s work on user fee legislation and other issue areas, click here.