Trump user fee proposal surprises industry

The Trump administration proposed almost doubling medical product user fees, and tied the increased payments to regulatory reforms that would speed medical product development. The pharmaceutical industry was not consulted or informed in advance of Thursday's proposal, industry executives who participated in negotiating the PDUFA reauthorization told BioCentury. They said that FDA has not identified any regulatory reforms that would justify a $1 billion annual increase in user fees.

Details of the administration’s budget proposal are expected in May, the White House said. Many of the administration’s proposals are likely to be modified or discarded in the congressional budget process. ...