Food and Drug Administration Law (20616). 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's regulation over the health care products market, the noteworthy legislation that has shaped its oversight in this area, 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 (this course will not cover food law). 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 interactive discussion introducing students to the material, including hypothetical cases that will require students to apply the day’s lessons and themes in determining legal and policy solutions. Students with high quality papers will be given specific guidance in submitting them for publication in the peer-reviewed medical/public health/policy literature. Paper of 2,500-4,000 words is required. Paper required. Enrollment limited to twenty. A.S. Kesselheim.
Note: The first meeting of this class will be Wednesday, August 31 from 4:10-6:00 p.m. in BAKER A005; there will be no class on August 29. Afterwards, this class will meet in eight additional sessions on the following Mondays: September 12, September 19, Septembr 26, October 17, October 24, November 7, November 14, and November 28.