Diana Winters, IU Robert H. McKinney School of Law

Principal Investigator: Diana Winters, associate professor, IU Robert H. McKinney School of Law

Project Title: Food and Drug Law, Online

Funding Level: $5,000

Abstract:

This project involves designing a 3-credit Food and Drug Law class to be delivered online or with a hybrid component so that some classes could be delivered live. Food and Drug Law examines how the Food and Drug Administration regulates food, drugs, and medical devices. We will study how Congress authorizes agencies like the FDA to regulate, and the judicial review of agency action. Topics include the history of food and drug regulation and the Food and Drug Administration, the jurisdiction of the FDA, food regulation (including safety, labeling, and nutrition policy), the regulation of dietary supplements, the regulation of drugs (including labeling, promotion, new drugs, post-approval obligations, and generic drugs), the regulation of medical devices, the regulation of biotechs (including vaccines and blood products), and tort liability for sellers of food and drugs. This course will be particularly effective in an online format. Education research has shown that online courses may have the potential to improve learning outcomes. An asynchronous design, as will be used for Food and Drug Law, can improve student participation and allow for the use of pedagogical innovations.[1] Moreover, the increased convenience offered through this format will broaden the class’s appeal.[2] The Food and Drug Law course proposed here will incorporate (1) low stakes assessments in the form of small scale writing assignments, and (2) visual media to aid students in understanding the concepts explored in a real-world context. These methods will work to help generate student interest in the material and facilitate a richer learning environment.