User fees under scrutiny
In March, the Trump administration’s proposal suggested doubling medical device user fees to $2.4 billion in a bid to lower taxpayer funding of the FDA.
In May, HHS Secretary Tom Price called to cut congressional appropriations for the FDA and hike user fees.
Price wrote: “To ensure the FDA has the critical resources needed to keep pace with this field, the President’s Budget Blueprint proposes to increase and restructure the medical product user fee programs at FDA to be 100% user fee supported programs, with no funding triggers that require budget authority financing.”
However, the secretary’s request was too late to be considered for 2017 reauthorization bill.
In June, the “FDA Reauthorization Act of 2017” proposed medical device companies put up a collective $1 billion in user fees, which pharma firms putting up another $8 billion for drug reviews, the budget office estimated. The bill would raise direct spending by $13 million and lower revenues by $2 million from 2017 to 2022 but raise the total deficit by a paltry $15 million from 2017 to 2027, the Congressional Budget Office estimated.