The Policy Connection
In Foundations of the Law, Professor’s Bailey Kuklin and Jeffrey Stempel assert that “during its history, United States law has frequently resulted from commercial, geographic, social and political conflict” (1994:138). The regulation of medical products is no different; various perspectives apply to various constituents or stakeholders. Whether one is a patient, a medical practitioner, a developer of medical products “industry,” an academician, a legislator/regulator or a special interest entity, views are closely aligned by individual or collective interest, inherent philosophical beliefs, and conscious or unconscious ideologies and pedagogies.
The underlying construct for the regulation of food and drugs is in seeking a balance between prevention of harm vs. promotion of benefits and the public good. Finding the right balance shifts with political and societal changes over time. The political changes reflect the mandate of a party’s platform and have a direct bearing on what the overall “annual goals” would be. The societal changes can be political, economic, social, and technological or scientific/ technological advancements. What makes administrative law unique and has regulatory agencies in a conundrum is that they are ultimate responsible to everyone and have a perceived duty to be balanced. They are responsible to congress, the judiciary, legislators, the executive branch, industry, special interests and the public at large. Regulatory agencies are ultimately in a battle for legitimacy and this takes a toll on resources and indeed agency morale.