Trump Administration’s surprising call for increased user fees probably won’t have much impact on pending reauthorization process, but it does put on the table an important question for the biopharma industry to consider for the long term: should FDA be fully funded by user fees?

Success of review model for new molecular entities and novel biologics should bolster US FDA and industry's stance that Congress reauthorize the user fee program without tinkering with the negotiated agreement, which retains the 'Program' but builds in more flexibility.

The biopharmaceutical industry is hoping the terms set under the negotiations with the FDA for the sixth round of the Prescription Drug User Fee Act will help reduce the time and money spent on developing medicines, allowing companies to get their products into the commercial setting quicker and maximize those therapies' potential.