Exceptionalism in Predictably Challenging Times

Most of us in political Washington spend August catching up on earlier work and preparing for activities that will be carried out in September and the Fall. August itself is typically a quiet month with little direct action. Further, with this year’s early Presidential nominating conventions and the long Congressional recess, it seems like August started in July. And in a sense, it did.

This compares with FDA, which is never quiet and never out of action. For the agency, August is just another busy month. While individuals may take vacation, FDA never does, a theme we explored recently.This week, I would like to explore a different, but related theme: FDA exceptionalism.

All too often, FDA is lumped together (by Hill staff and media) with other regulatory agencies, such as the SEC or the EPA. Not only are there critical mission-based differences that distinguish FDA from the others, but regulatory agencies are also deeply unpopular. It is not a neighborhood FDA should want to live in if it needs continued Congressional support for its funding needs. A better comparison is to say that FDA is a public health regulatory agency and that it has as much or more in common with public health agencies, such as NIH, CDC, etc., as it does with other regulatory agencies.In fact, it is both most accurate and truthful to say that FDA is unique -- it is an exception to everything we think we know about regulatory agencies and public health agencies. The agency both protects consumers and is a gateway for products that contribute to good health and help grow our economy. The agency oversees products that represent about 20% of all consumer spending in the United States.

FDA is also an exception in that both consumers and regulated industries support the agency. The Alliance is itself proof of this.This is not to say that FDA is supported by stakeholders in everything it does. There are always areas of disagreement that need to be worked through. However, the FDA’s science-based decision-making and the processes it uses to receive input can also be said to be unique. A former commissioner of the FDA once told me -- when referring to another government agency -- that whenever they acted it made FDA look good by comparison.As we prepare for what could be a rough Fall and a bruising governmental transition -- when lots of assumptions will be challenged -- please keep talking about the exceptional ways in which FDA acts on behalf of all of us.

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