FDA Must Do More ... But How Much More for Less?

When I say “FDA never sleeps,” I am usually referring to the global presence and impact of the FDA. Like the proverbial British Empire, the sun never sets on FDA.But “FDA never sleeps,” also has another meaning: FDA is committed to self-improvement and can never be satisfied with the status quo. Assuring the safety and efficacy of medical products and the safety of foods is never-ending. And there is always the challenge of carrying out FDA regulation with more transparency, stronger science, and greater stakeholder involvement.In short, FDA never sleeps: each day it is required to do more ... and to be more ... than it was the day before. This may seem obvious to us -- why is it hard for some policymakers to grasp the notion of a perpetually improving FDA?The answer lies in the overall budget and spending mess in which our country finds itself. Most federal agencies have received little or no budget growth over the last few years. The assumption is that they can find a way to carry out last year’s work-plan for the same money (or less) in the current fiscal year.  This actually makes some sense if the agency’s mission is static ... and many are.In contrast, FDA’s mission grows dynamically every year. It is not static. The Alliance usually points to: new legislative mandates; more complex science; and the globalization of FDA-regulated products. For these reasons, every year FDA is busier than the year before. This is true across all centers and programs at FDA.Over time, an increasing number of policymakers have come to understand that the FDA’s mission evolves and grows larger each year. Despite this, FDA is impeded by the larger budget environment: the Ag/FDA appropriation bill for FY 17 is 2% smaller than the budget for FY 16.  Fortunately, FDA needs are proportionally very small. Giving the agency $100 or $200 million more in appropriated funding -- which can be fully justified -- just requires a tweak in the allocation of funds. If there is an omnibus bill, we hope Congress will find a way to accomplish this.Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.