FDA mum on Trump plans to hike user fees

FDA center directors who testified at a Senate hearing Tuesday on user fee reauthorization shed no light on the Trump administration’s plans to double medical product user fees and slash taxpayer support for the agency. The White House's FY18 budget proposal included a “recalibration” of FDA medical product user fees to more than $2 billion, which it said would replace the need for new budget authority to cover premarket review costs (see BioCentury Extra, March 16).

Industry would have to agree to an increase, and is unlikely to do so, CEOs involved in negotiating PDUFA told BioCentury. ...