Congress Unveils FDA User Fee Reauthorization Package

Congress unveiled its first draft of FDA user fee reauthorizations, with total dollar amounts in line with those previously negotiated by regulated industry.

Capitol Hill chose not to adopt the plans proposed by President Trump earlier this year, which included raising total FDA user fees to over $2 billion. Instead, PDUFA, GDUFA and BsUFA would gather $1.42 billion in fiscal 2018, up from the $1 billion set for fiscal 2017.

The health committees of the House and Senate released a discussion draft of the FDA Reauthorization Act of 2017, marking the start of the final stretch of legislative work before the current programs expire at the end of September. The bill would help fund the agency’s review programs through 2022.

The base fee amount collected under PDUFA in fiscal 2018 will increase to $878.59 million, up nearly $160 million from fiscal 2017’s $718.67 million.