This course explores the full range of federal regulation of products subject to the jurisdiction of the Food and Drug Administration (FDA). These products include food, human prescription and nonprescription drugs, animal feed and drugs, biologics and blood products, medical devices, and cosmetics, which together comprise approximately 25% of the gross national product. The course examines the public policy choices underlying the substantive law, FDA enforcement power, and agency practice and procedure. The course covers such contemporary issues as protecting against unsafe or mislabeled food, controlling carcinogens, expediting approval of AIDS and cancer drugs, assuring the safety of prescription drugs before and after marketing, importing drugs from abroad, switching drugs from prescription to nonprescription status, balancing the benefits and risks of breast implants, the compassionate use of experimental products, regulating complex new medical device technology, control of such biotechnology techniques as gene therapy, requiring adequate consumer and professional labeling for FDA-regulated products, and the relationship among international, federal, and state regulatory requirements. A prior course in Administrative Law is desirable but not a prerequisite.
Enrollment in this course is limited to fifty-two students. Forty-seven will be enrolled through the general course preference selection. The remaining five places will be reserved for students who do not get a seat through the preference selection but who choose to combine the course paper with Option 1 of the J.D. Written Work Requirement.
The required course paper may be combined with the Option 1 Written Work Requirement. This applies to students who take the course as a 2L or a 3L. Students who know that they wish to choose this option should e-mail the instructor at email@example.com.
Text: Hutt, Merrill, and Grossman, Food and Drug Law (3d ed. 2007) and Statutory Supplement (2013).