Congressional Research Service

In the first year of PDUFA contributions to the FDA budget, user fee revenue accounted for 9.7% of the Human Drugs total program level. By FY2016, user fee revenue increased to 64.7% of the Human Drugs program

this includes revenue from PDUFA, generic drug user fees, biosimilar user fees, and outsourcing facility fees.

FDA, industry groups, and many Members of Congress generally see PDUFA and the other human medical product user fees as must-pass legislation.

The general view is that PDUFA has succeeded. FDA has added review staff and reduced its review times.

For decades, FDA had asked Congress for permission to implement user fees.

Industry, consumer groups, and FDA agreed that the time from submission of a drug or biologics application to FDA's decision was unacceptably long.

In the late 1980s, the median time for FDA to approve a new drug application (NDA) was 29 months.

could be the difference between life and death

During negotiations with industry, FDA must hold monthly discussions with patient and consumer advocacy groups

Minutes of all negotiation meetings between FDA and industry are required to be posted on the FDA website.

In FY2007, prescription drug user fees provided 56% of the PDUFA program total costs (appropriations provided 44%); in FY2016 (from the most recent financial report available), user fees covered 72% of PDUFA program total costs

Prior to the passage of GDUFA I, generic drug companies submitting ANDAs were not subject to user fees from FDA

In FY2013, the first year generic drug user fees were collected

Some critics of the current scope of the user fee programs are concerned that FDA's mission to protect public health may be compromised if reliance on these fees affects the impartiality of FDA's scientists.