Advisors to lawmakers who will lead next year’s FDA user fee reauthorization legislative process are urging FDA and device industry negotiators to complete MDUFA V negotiations as soon as possible. During a recent panel discussion, they also previewed potential diagnostics and digital health reforms that may be added to the must-pass user-fee bill next year.
“Whoever is involved in MDUFA, I think all of us are happy to say, ‘let’s get something, please, as soon as possible.’”
That was the plea from Santiago Gonzalez, senior health policy advisor for Sen. Michael Bennet (D-CO) during a panel discussion organized by the Food and Drug Law Institute November 9. Gonzalez and several other Hill staffers on the panel said they were anxious to get a device user fee agreement in hand so lawmakers could move forward with an FDA reauthorization as efficiently as possible in the new year.