Jack Bierig : Courses and Seminars
Food and Drug Law
This course explores legal and policy issues in the federal regulation of foods, drugs, medical devices, and other products coming within the jurisdiction of the FDA. It will examine substantive standards applicable to these products and procedural issues in the enforcement of these standards. It will also address the tension between state and federal regulation in this area, constitutional constraints on such regulation, and a variety of other issues relating to the development and marketing of regulated products. The student's grade is based on class participation and a final examination or major paper.
Health Law and Policy
This course will explore various policies that underlie regulation of the provision of health care in the United States. We will begin with an examination of the principal government programs for financing the delivery of health care in America, Medicare and Medicaid. This first third of the course will focus on how these programs seek to resolve the tension between controlling costs, promoting quality, and assuring access. We will next address other federal legislation affecting the delivery of health care, including the Affordable Care Act. We will then move to a consideration of policy issues relating to managed care organizations, including the functioning of these organizations and the impact of ERISA on their actions. Next, we will explore issues relating to the behavior of physicians, hospitals, and nursing homes. This exploration will focus on the impact of the antitrust, labor, and tax laws on these entities. The goal of the course is to expose the student to the conflicting law and policy issues that impact on the delivery of health care in this country.