INDUSTRY PUSH FOR LOWER USER FEES COULD CONFLICT WITH FDA RESOURCE DEMANDS
The device industry is engaged in closed-door talks with the FDA over its user-fee program, in which firms pay the agency when they submit their applications for product approvals. Those user fees are meant to help speed up the approval process so products can be introduced more quickly to the market.
With a new Democratic-led Congress that is likely to push for more FDA funding, those funds will have to come from somewhere -- and that somewhere is likely to be higher user fees, sources said.
A proposal from AdvaMed would stabilize FDA funding while cutting user fees. Under the proposal, the agency would charge fees for some services it now provides for free, such as plant inspections, and reduce product approval fees.