Topics in Food and Drug Law
The U.S. Food and Drug Administration has the regulatory mandate to protect the American food supply, and to ensure that drugs are safe and effective for the purposes for which they are prescribed. This course will survey selected topics in food and drug law, including the new drug approval process, regulation of food additives and carcinogens, food labeling and nutrition, prescription vs. OTC drug status, and restrictions on pharmaceutical marketing. Related legal standards affect all of us as consumers in every day life, and have even greater impact in circumstances like end-of-life decision making. In examining food and drug law issues, we will focus on the tension between information gathering, risk regulation, and paternalism as themes in FDA policy making.