April 4, 2022
House Committee on Energy and Commerce hearing on FDA user fee reauthorization | Ensuring safe and effective medical devices
On March 30, the House Committee on Energy and Commerce held a hearing entitled "FDA User Fee Reauthorization: Ensuring Safe and Effective Medical Devices." Since its inception in 2002, the Medical Device User Fee Amendments (MDUFA) — which authorizes the Food and Drug Administration (FDA) to collect user fees from companies producing medical devices — must be reauthorized by Congress every five years. The most recent MDUFA reauthorization was enacted as part of the FDA Reauthorization Act of 2017 and expires on September 30, 2022. Although the statutory deadline for transmitting a final performance goals letter for MDUFA V was January 15, 2022, the final performance goals letter has not yet been transmitted to Congress. Instead, the Department of Health and Human Services (HHS) provided a draft performance goals letter to the Committee on March 22, 2022.
The draft performance goals letter contains FDA's commitments on review timelines, hiring estimates, and program enhancements for MDUFA V. The proposal includes funding increases to support the hiring of additional staff, the creation of programs such as the Total Product Life Cycle Advisory Program (TAP) — aimed at spurring rapid development of safe, effective, and high-quality medical devices of public health importance — a commitment to improving diversity and patient engagement in clinical testing, and other process improvements to enable more timely reviews and greater access to safe and effective medical devices.
During the hearing, committee members emphasized the role of MDUFA in enabling access to innovative medical devices and stressed the importance of authorizing MDUFA V by the September 30 deadline. While Chairman Frank Pallone (D-NJ) and other committee members expressed concern over the missed statutory deadline in transmitting their performance goals, he said Congress will get the program reauthorized so that FDA isn't forced to lay off staff paid through the user fee program. Center for Devices and Radiological Health Food and Drug Administration (CDRH) witness Dr. Jeff Shuren apologized for the delay, citing the significant burden that the COVID-19 pandemic had placed on his team and noting that the MDUFA V draft agreement would substantially improve their ability to meet these challenges and ensure patient access moving forward.
Reference was also made during the hearing to two related bills: 1) H.R. 7084, the "Protecting and Transforming Cyber Health Care Act of 2022" or the "Patch Act of 2022," which would require premarket submissions to include certain information related to cybersecurity; and 2) H.R. 7192, the "Diagnostic Device Advisory Committee Act," which would establish a panel of experts on diagnostic devices within the Medical Devices Advisory Committee at FDA.
More information is available here.
Additional information is also available in the attached Tax Alert.
Energy and Commerce hearing on FDA user fee reauthorization