Title: The FDA and the Political Pendulum : A Preliminary Look Back at Authority, Challenges, and the Future of the Agency (2008 Third Year Paper)
Author(s): Nathan B. Elliott
Subject & Subject keywords: Food and Drug Law "politics"
Abstract:This paper will be an examination of the FDA’s power. It will look at how the agency’s authority has transformed radically in the 20th century, and will evaluate recommendations to the challenges currently plaguing America’s premier consumer protection and health agency. Some of those irresolvables that will be treated in the paper include the issue of pharmaceutical product recalls, new technologies and their emerging hazards, as well as some of the progressive proposals germinating in Congress that will transform the agency. The role that politics have played in the administration of the Food and Drug Administration remains a central theme to this paper. I will highlight the challenges FDA has in making scientific and labelling determinations. The langostino lobster case will be used to highlight the political intersections between the FDA as a scientific agency and as political football. The role of the courts in limiting the FDA’s authority will be treated, as well. Some of the cases that will be analyzed are Western Legal Foundation v. Henney , Thompson et. Al v. Western States Medical , Pearson v. Shalala , and FDA v. Brown & Williamson Tobacco Corp . The last part of the paper will look more closely at reform proposals and interrogate the political abstinence of the agency, as well as current attempts to limit and expand the agency’s authority. This will include a brief examination of the more recent Congressional enactments to both limit and expand the authority of the Agency, including the Nutritional Education and Labeling Act, the Dietary Supplements Health and Education Act, the Modernization Act, and the May 2007 reauthorization of the Prescription Drug User Fee Act. My hope is that by the end of this paper, we will understand the Food and Drug Administration as more than a massive, sterile and removed federal agency that overseas consumer public health, but rather, a general understanding of the agency’s future authority and challenges must be considered via a political lens; and those future predications as to the legal topography of Food and Drug law only promise to be more irresolvable as the FDA’s authority continues to ebb and flow, subject to the whims of political animus and national tragedy or anxiety.