Beyond health insurance and the delivery of health care, goods and services related to individual and public health are highly regulated in the United States, and often serve as a basis for international regulations. These goods and services are a large and growing part of the U.S. and world economy, with some estimates being that more than one-quarter of U.S. food and medical products are regulated by the FDA alone. This regulation is carried out directly by a variety of State and Federal agencies (such as the FDA, the CDC, and the NIH) as well as indirectly through the purchasing power of federally financed programs, such as Medicare.
This course will include an introduction to the basic legal and regulatory frameworks within public health and an overview of the Constitutional limits and policy choices that have led to current law. The course will then move to a review of several major fields of regulation. From a high-level, this includes the regulation of health professionals, health systems, and medical or food products impacting human health. The course will then conclude with an examination of several contemporary problems, such as the safe and effective use of human drug products, infectious-disease prevention and control, ethical research practices, and rationing and allocation of limited resources.
The primary objective of the course is to teach students about the regulation of public health at the intersection of state and federal levels, recognizing that such regulatory frameworks often become the template for international policies. Students will be called on to learn the basics of two fundamental statutes—the Public Health Service Act (PHSA) and the Food, Drug and Cosmetic Act (FDCA). Students will also be called upon to follow examples of administrative change under these statutes, each year analyzing a new set of proposed regulations and sub-regulatory guidance documents. By the end of the course, students will be able to describe the major means by which goods and services used in both personal and public health are controlled, as well as areas in which future changes are likely.
Currently, there is no text or case book on this subject. The primary readings will be assigned by the professor.