Title: Pliny the Elder Meets James Madison (1994 Third Year Paper)
Author(s): Michael R. Pompeo
Subject & Subject keywords: Food and Drug Law "federalism" "states' rights" "regulatory mechanisms" "regulatory reform"
Abstract:The Founding Father's vision of the state is much different from the its modern counterpart - - the administrative state; technology, massive population growth and economic integration have made it so. Through all of this, however, the fundamental values expressed by Madison and Hamilton, and hinted at in the above quoted passages, remain touchstones for effective governance: avoiding the loss of personal autonomy from excessive governmental intrusions, establishing a responsive governmental mechanism to address local concerns,4 and the control of the deleterious effects of faction. In sum -- deliberative democracy.

It is often decried that the rise of the administrative state has been the death knell for these treasured values -- that intrusive, rigidly centralized, and industry-captured agencies have virtually banished the Framer's vision of a deliberative democracy. This paper will explore that claim through the vehicle of the FDA. More importantly, I will argue that a renewed commitment to these values is needed in our approach to regulating health safety. The fundamental importance of FDA's activities to both citizens and industry alike makes the agency an excellent model against which to both measure the federal government's record in effectuating the democratic values provided by the Framers and for considering how it and other agencies might improve upon this record in the future.

Let me begin by with a disclaimer. This paper cannot hope to answer of even address all of the questions which it raises. My more modest objectives are threefold. First, to put forth the normative proposition that agencies, including agencies such as FDA tasked with reducing public risks, have an affirmative duty to consider the importance of deliberative democracy in developing and enforcing the regulatory regimes with which they are entrusted. Second, to use current FDA regulatory mechanisms as examples of success and failure in promoting these norms. I conclude that this very modern agency, though not unblemished, has actually functioned so as to promote many aspects of the Framer's vision. Finally, I will argue that in spite of this success, much more can be done. If FDA were consistently measured against a more comprehensive standard of promoting public welfare, as opposed to the cramped current use of longevity as a proxy for success, then the agency could, and inevitably would, reconfigure its regulatory mechanisms in a manner even more consistent with the values of our deliberative democracy.