Title: IN SEARCH OF THE OPTIMAL BALANCE: FDA'S SAFETY MANDATE AND THE AUTONOMY RIGHTS OF INDIVIDUALS (1994 Third Year Paper)
Author(s): Andrew F. Schmolka
Subject & Subject keywords: Food and Drug Law "consumer protection" "FDA mandate" "FDA policy"
Abstract:Although he most assuredly was unaware of it at the time, the nineteenth-century British philosopher John Stuart Mill had much to say about the operation of the Food and Drug Administration in twentieth-century America. In On Liberty, a seminal essay in the development of autonomy theory published in 1859, Mill first formulated his now-famous "harm principle," which posits the following: Each individual in society is sovereign over his own body and mind, such that he is at liberty to act according to his own will, as long as he does not unduly infringe upon that same freedom enjoyed equally by others. It is perhaps this concise statement that most forcefully captures the essence of the libertarian underpinnings of American government, which have evolved from the adoption of the Bill of Rights in 1791, to the pioneering of the U.S. Supreme Court's "right to privacy" jurisprudence in the 1960s, and beyond to today. Because the fundamental belief in the supremacy and autonomy of the individual in society has deep roots in the development and history of America, it necessarily has important ramifications for the administration of food and drug law in this country. Indeed, for application in this specific context, I propose to reformulate the "autonomy ideal" to hold as follows: "As a sovereign individual, I must be allowed complete freedom to determine how what I do will affect my own body -- in terms of the food I eat, the drugs I take, the medical devices I use, and the cosmetics I wear." At the same time, however, government exists by definition to protect the public good, to defend the collective interests of society. Chief among these concerns are health and safety, which the FDA is responsible for safeguarding. As the administrative agency charged with monitoring goods essential to everyday life, FDA has a critical role to play in protecting unsuspecting Americans from the invisible dangers that otherwise could threaten them on a daily basis. The science on which health and hygiene are based has advanced to the point where it is beyond the understanding of most Americans. If profit-seeking producers and distributors of FDA-regulated goods were permitted to do business with American consumers in the absence of any government supervision, then eating a snack, taking an aspirin, or applying lipstick could mean the difference between health and sickness, or perhaps even life and death. Thus, in the special sphere of FDA operation, where the agency's mandate is essentially to oversee the everyday life of Americans in the interest of protecting their health and safety, the formula for determining the appropriate contours of individual autonomy is peculiarly complicated.