For FY 2016, FDA is requesting $4.9 billion to support our essential functions and priority needs, which is $425 million above the FY 2015 enacted level. Of the total funding, $2.7 billion in the budget authority and $2.2 billion in user fees. The FY 2016 increase consists of $148 million in budget authority and $277 million in user fees. Will the increase in user fees drive more FDA inspections?
User fee monies come from new health care sponsors applying for FDA approval to speed up the time it takes to get an audit scheduled. The user fee monies go toward FDA operating cost and employee payroll.
This means the FDA will be expected to conduct more inspections to meet the demands placed on it by collecting user fee monies – but this idea raises a number of questions:
- Will FDA be able to increase the number of clinical trial audits globally in order to keep up with the user fee expectations for audit schedule?
- Has FDA increased training for bioresearch monitor training and have trained inspectors ready to meet this challenge? FDA’s focus has been on food and tobacco inspections in the last few years. The latest’s initiatives have been focused on compound pharmacies, the drug inspectorate, and the “antimicrobial blitz for use in feedlots & human use for resistance strain reducing strategy.”
- Will FDA also increase the amount of health care products approved for the domestic market as well?
The drug shortage list has remained at high levels for the past few years and this fast track approval change is definitely part of the mitigation effort. Most of the budget increase comes from private industry and new product developers so the government burden is around one hundred and fifty million (2.7 billion total). We can only hope the FDA is able to meet the increased demand for audit increases and is not postponing regulatory oversight due to limited trained staff shortfalls.
Patrick Stone is President of TradeStone QA and the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.