FDA Can't Just Pare Back Without Risk for Harm

Compared to conducting the same activities and making the same types of decisions every day, building organizational flexibility costs money. When it comes to FDA, it is money well-spent. Today, we will look at why.

One of the fallacies we often run into on the Hill is: surely every federal agency could be at least 5% more efficient -- through more focused prioritization, better use of manpower, and elimination of unnecessary activities. Therefore, why can’t we cut budgets 5% without causing any harm?

There are, of course, myriad problems with this reasoning. At least for FDA, we keep reminding Congress that FDA’s mission and responsibilities are not static from one year to the next. There are a number of new laws the agency is implementing. Plus, scientific complexity increases every year and globalization is an incredible challenge that shows no sign of leveling off. Even apart from legislation, there are new problems uncovered every year that require the agency’s attention in the form of increased activity and new programs. So, out of necessity, FDA adjusts  priorities, uses manpower better and eliminate unnecessary activities. In the process, the agency becomes more efficient every year.

However, whatever is saved ... is re-purposed to pay for those new or expanded activities. New demands always exceed whatever amount has been freed up. That’s why the agency needs a larger appropriation to carry out its mission.What FDA has not been willing to sacrifice in this tight budget era is its organizational flexibility. Right now, that is reflected in the agency’s efforts to deal with the Ebola situation. CDC and NIH are grabbing the headlines, which is fine, but FDA is an essential element of the government’s response. We all know it is taking up a lot of agency time and manpower that was surely intended for other activities.Last year (and this), there has been a need for extra resources for food safety draft guidances and regulations, involving substantial re-purposing of individuals from important projects that will just have to wait. The year before that (and ever since), FDA has re-focused some of its drug review priorities to spend more time on the new breakthrough drug program. It is a vision, shared by Congress and FDA -- that this is the right thing to do to advance therapies for the neediest of patients. We can’t know for sure whether, in the end, this costs more to implement. We do know that the hours reviewers put into the breakthrough program are hours not available for other activities.

When we make our case for more resources, organizational flexibility at FDA makes many new initiatives possible. The cost is in what doesn’t get done -- which is often quite important and a priority. Not everything can be pared back without harm.

Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.