FDA Still Stretched Too Thin to Accomplish Its Mission

Both the House and the Senate FY 15 appropriations bills call for greater accountability and oversight of FDA. As long as the intent is promote effective and efficient government, we see nothing objectionable in this.What concerns us is having this justified because of the “60% increase in agency funding,” over the past 5 years as if:

• The increased funds were supporting the same activities. (They aren’t.)
• The agency’s bench is now deep. (It isn’t.)

With new statutory responsibilities, globalization, and increasingly complex science, FDA is still stretched too thin to fully accomplish its mission.As can be seen below, the entire agency has grown over those 5 years ... but the largest shift has been the tripling of user fees. Two-thirds of that has been the addition of tobacco user fees ($500+ million) and generic drug user fees ($300+ million). For budget authority appropriations, the biggest shift has been for CFSAN ($230 million).Here is what the 5-year analysis looks like: Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA