Reflections on law and legal foundations…..
Among the various schools and paradigms of thought, it is difficult to assess where we are, without first exploring the history and purpose of food and drug law. The Federal Food, Drug & Cosmetic (FDCA) Act was the first comprehensive federal law regulating food and drugs. It was strictly an enforcement statute and designed to punish violations. It was born out of the problem with the current regulatory environment in 1933. Since it passage in 1938, there have been numerous amendments, both expanding and contracting its reach. There has also being challenges to relax and likewise tighten medical product regulation.
Eugene Bardach writes that “regulatory agendas are often said to become captured by the industry they regulate.” The agendas are also dictated by the legislative and executive branches of government. As history of food and drug law has thought us, you must have a tragedy, followed by public outrage, followed by new legislation or legislative authority. Instrumentalism/ functionalism and formalism structure the realm and basis of food and drug law in American society. One can argue that legal realism is at play, but that would require us to assume that the FDA is not a “Scientific” regulatory agency. The legal framework of Food & Drug Law is Administrative Law and thus concerned with both the rule and the legislative intent in adjudicating cases or promulgating regulations and guidance.