Behavioral and Social Factors in Public Health

Catalog description

This course explores the full range of legislative, regulatory and policy issues and surrounding law of products subject to the jurisdiction of the Food and Drug Administration: food (including dietary supplements), drugs, biologics, cosmetics, medical devices and tobacco. While the focus will be on the Food, Drug & Cosmetic Act, the Federal Trade Commission regulation of advertising and the Consumer Product Safety Commission enforcement of the Poison Prevention Packaging Act will be included. We will consider the role of Federal, State and international regulation; incentives in the development of products, including patent incentives and exclusivity; tort liability and its role in industry regulation; commercial speech protections in advertising; no risk policy for carcinogens and use of biotechnology in foods. The interface between food and drug regulation and subjects such as environmental law, medical malpractice and health law, policy and bioethics will be reviewed.