N2 Universal: A Case Study of an NDA

Abstract

Food and drug law, like all areas of administrative law, is rife with tension among countervailing principles. The Food and Drug Administration is charged with protecting the health and safety of the American public. This mandate involves competing considerations. First, the FDA must ensure that drug innovation is promoted so that effective new treatments are introduced as quickly as possible and at the lowest cost possible; but, FDA must also ensure that no drugs are allowed to be marketed which may cause injury or death to a patient or which are ineffective in treating the disease for which claims are made. To allow FDA to achieve this difficult mission, Congress and the courts have given the Agency unprecedented discretion over private drug manufacturers and health care practitioners. This bureaucratic discretion is in tension with our democratic notions of due process and fairness that government should be restrained by pre-existing rules and legal principles and that each person, or drug manufacturer, should have the opportunity to participate in government actions which affect a personal, professional or financial interest.