Food and Drug Administration Law (21767). 1 or 2 units, with a credit/fail option. The Food and Drug Administration (FDA) is the premier consumer protection agency in the United States, with control over the availability and public discourse about potentially life-saving therapeutics, foods, supplements, and related consumer products. Its authority has been built in response to public health crises, and is constantly under scrutiny from all sides of the political spectrum. In this course, we will review the history of the FDA, the noteworthy legislation and regulation that have shaped its oversight of the health care products market, Supreme Court and other cases that have impacted its authority, and an introduction to key current controversies related to the FDA that affect health care delivery (we may devote one class to food law issues, based on student interest). The enduring theme will be how the FDA balances its vital public safety role against countervailing forces of personal autonomy and the rights or interests of consumers, patients, physicians, and corporations. Each class will be organized around a lecture—with interactive discussion—introducing students to the material, and most classes will contain a hypothetical case that will require students to apply the day’s lessons and themes in determining legal and policy solutions. A shorter paper is required for 1 unit; a paper of 2,500-4,000 words is required for 2 units. Students with high quality papers will be given specific guidance in submitting them for publication in the peer-reviewed medical/public health/policy literature. Open only to J.D. students. Paper required. Enrollment capped at twenty. A.S. Kesselheim.
Note: This class will meet in seven sessions on the following dates: January 26; February 2, 9, and 23; March 2, 9, and 23.