The goals of FDA regulation and the challenges of meeting them.

Author:Tyler, Ralph S.

The subject of this article is regulation, specifically regulation of products within the jurisdiction of the United States Food and Drug Administration (FDA). My perspective is, of course, shaped by my former work as counsel to FDA.

For students of administrative law and for lawyers practicing before administrative agencies, terms such as "administrative law" or "regulatory law" bring to mind legal doctrines such as delegation of legislative authority from Congress, for example, or statutory principles such as notice and comment rulemaking. These doctrines and principles are certainly important to parties affected by agency actions, to counsel who practice before agencies, and to courts reviewing agency actions. I would argue, however, that these doctrines and principles provide very little insight into most of the substantive work in which regulatory agencies are engaged every day. In addition, these legal doctrines and principles do little to inform our ongoing national debate about the proper place of regulation in our economic system.

Two fundamental questions must be addressed to understand and to evaluate the work of an administrative agency. First, is there a need to regulate in a particular area? And second, how should an agency operate to solve the problem which was the reason for determining that a need for regulation existed? Obviously, one reaches the second question of "how to regulate" only if the answer to the first question is that there is a need or reason to regulate.

Why, then, do we have an FDA? Put another way, do we need an FDA? The predecessor of the modern FDA had its origins in response to Upton Sinclair's classic novel, The Jungle, which was published in the early 1900's. The Jungle is remembered most often for its graphic depiction of the unsafe and insanitary conditions in the Chicago slaughterhouses of the time. The novel is about much more than that, however. The Jungle is the story of Jurgis Rudkis and his family, an immigrant family who are living a squalid, poverty-burdened existence in Chicago. This family is oppressed by all the institutional forces with which they are forced to interact, including employers, landlords, and financial institutions.

There is nothing subtle about the theme of The Jungle; the bluntly stated theme is that unchecked economic power acts in an oppressive fashion. For Jurgis Rudkis and his family, there is seemingly no prospect for relief from this oppression. In the final third or so of the novel, however, Upton Sinclair gives his answer to how the crushing burdens of the Rudkis family and others like them will be relieved. For Upton Sinclair, speaking through Jurgis Rudkis, socialism is the answer.

The Jungle had a huge impact. The United States, starting with its then President, Theodore Roosevelt, took to heart the social and economic problems which Upton Sinclair portrayed so effectively, but rejected Sinclair's solution. The American model--the public policy response to The Jungle--was not socialism, as Sinclair proposed, but the establishment of institutions of public power to balance, if not control, the major institutions of private power. The United States Food and Drug Administration is perhaps the most prominent example of this model.

FDA exists because of the belief that without regulation--meaning governmentally established and enforced rules and standards--life-essential goods such as safe food and safe and effective drugs and medical devices are less likely to be available. I submit that this belief is rooted in fact. Consumers lack the information and the ability to monitor the safety of the food supply chain once the world changes from a place where people grow their own food or obtain it from their neighbors to a world in which food is grown and packaged far from where it is consumed, now often in other countries. Similarly, with respect drugs, there is no substitute for a well-controlled clinical trial to establish a drug's safety and effectiveness and conducting such a trial is beyond the competence of individual consumers. Consumers, unprotected by regulations requiring such trials, are unable to judge the safety and effectiveness of a drug.

The alternative to regulation in the areas of food, drugs, and medical devices is a marketplace flooded with products which carry no greater assurance of safety, efficacy, and purity than the unverified and self-interested representations of those producing the products. Because of the risks inherent in that alternative, there is a strong consensus in our country and, indeed, across much of the world that regulation in the areas of food and medical products is necessary.

There are many complaints about how FDA operates. These complaints focus on the agency's fairness, including the perception of some that it is too close to the industries it regulates, its effectiveness, its slowness, and the costs of compliance. What is notable, however, is that few people, even FDA's severest critics, suggest that consumers would be protected adequately, let alone better protected, if there...

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