The National Health Council Commends the FDA for MDUFA User-Fee Commitment

Fee Designed to Forge a More Patient-Focused Approval Process

Washington, DC (October 25, 2016) – A commitment announced this week by the Food and Drug Administration (FDA) to increase industry user fees paid as part of the approval process for medical devices should help get safer and more effective devices to patients faster. The National Health Council (NHC) commends the FDA and medical device industry for the proposal they put forward.

The reauthorization of the Medical Device User Fee Amendments (MDUFA IV), once approved by Congress, will provide the FDA with increased funding over the five years of the agreement, which is slated to begin in 2017.

“Most importantly—and for the first time in a medical device user-fee agreement—FDA and the device industry are furthering their commitment to involve patients as a part of the approval and clearance process,” said Marc M. Boutin, the NHC’s Chief Executive Officer. “Focusing on patient input as well as patient-reported outcomes will result in medical devices that should more significantly and holistically improve the quality of their lives.”

“Additionally, the agreement includes a commitment to further explore the use of real-world evidence as part of the regulatory framework. If properly applied, real-world evidence holds the promise to provide a better understanding of how devices work in clinical practice and lead to new approvals and clearances of better devices. The outlined proposal will offer incremental steps to better understand how real world evidence can supplement existing regulatory requirements.”

MDUFA IV user fees will also be used to recruit and hire scientific review staff—a key element toward timely and adequate reviews and approvals.  

The MDUFA IV agreement can be viewed here. The NHC’s real world evidence letter to the FDA can be viewed here.

Founded in 1920, the NHC is the only organization that brings together all segments of the health community to provide a united voice for the more than 133 million people with chronic diseases and disabilities and their family caregivers. Made up of more than 100 national health-related organizations and businesses, the NHC's core membership includes the nation’s leading patient advocacy organizations, which control its governance and policy-making process. Other members include professional and membership associations, nonprofit organizations with an interest in health, and representatives from the pharmaceutical, generic drug, insurance, medical device, and biotechnology industries.

Debra Z. Roth
Direct: 202-973-0550