Food and drug law is a huge subject, comprising at minimum the areas regulated by the US Food and Drug Administration: food (including dietary supplements), drugs, cosmetics, medical devices, and, as of 2009, tobacco products. In addition, the US Department of Agriculture has regulatory authority over animal products, the Federal Trade Commission regulates food and some drug advertising, and other agencies, particularly on the state and local level, also have regulatory power in this area. We will focus our attention in this course primarily on the Federal Food, Drug, and Cosmetic Act. That statute could fit into a small pamphlet when I began law practice; it is now hundreds of pages long (the 2009 tobacco law added about 80 pages, a similar-sized addition in 2011 covered food safety, 140 pages amending and adding user fees passed in 2012, 50 pages on drug quality and security were added in 2013 ...). In addition there are thousands of pages of regulations, guidance documents, and other important materials that practicing lawyers need to know about. Practitioners tend to specialize in one or another area because there is so much to know.
There is more than enough to keep us busy for a semester even for an overview. Therefore, at our first class I will inquire about the interests/backgrounds of class members, and use that information to make final decisions about how much class time to allocate to the various fields of regulation, and within each we will also focus on current issues of concern. Because the class will be relatively small, I will strive for it to be seminar-like in feel -- and it will require your active participation. The plan is for overview reading and an overview lecture or lectures, with question and answer time, for each topic, and then reading materials that will highlight important issues and current controversies and problems. The latter will be discussed through the format of regular in-class "policy debates" on those issues and controversies. (For example: are drug approval requirements now inadequate or too stringent? Should Congress pass legislation that would enable prescription drugs to be sold on the basis of lesser evidence?) You will be assigned (volunteer!) for one side or another, you will be “lead” on one or more debate, and 20% of your course grade will be based on your knowledgeable participation.
In addition, groups (of 2 or more, depending on class size) will pick a subject of interest to them (which may be from beyond the FDA world, involving another food/drug-regulating entity) to explore and teach to the class at the end of the semester. Groups will be asked to include in their presentations a "takeaway" such as a proposed change in regulations or statutes or a suggestion for change by government or industry with respect to the issues involved. This has always been a highlight of the course. (Recent course presentation titles: Big Pharma, Patents and Profit Protection; Medi-Spas; Rethinking GRAS: Safety and Efficacy; International Clinical Trials; The 23andMe Controversy; Marijuana; Genetically-Modified Organisms.) The group projects will be 20% of your course grade.
Our basic reading will come from the text A Practical Guide to FDA's Food and Drug Law and Regulation (5th ed. 2014) (http://www.fdli.org/resources/resources-order-box-detail-view/a-practical-guide-to-fda-s-food-and-drug-law-and-regulation--5th-edition). This text is published by the Food and Drug Law Institute (www.fdli.org), a nonprofit membership organization that brings together attorneys and compliance officers in government, industry, and the public interest who deal with regulatory issues. FDLI will sell it to everyone at the member price ($149), as I will describe in an email to all pre-registered students (and I will arrange a single shipment to save on shipping costs). There may be sources of some used copies online (beware out-of-date editions), and the book is likely to have resale value. You will also need an edited version of the Food, Drug, and Cosmetic Act, which I will make available to you in both a Word and a .pdf version. You will surely want a printed version, and can get it printed wherever you wish. Supplemental edited cases and other materials, along with a course syllabus that will be updated regularly, will be on Canvas; I will provide an appropriate link at the beginning of classes or by email before the semester begins. Each student will be able to decide what/how much of that material to print or to read electronically.
Why not a casebook? The long-time primary book in the field (by Hutt, Merrill, and Grossman), is more than 1500 pages long, and quite dense. You need to read a great deal to gain an overview of any given subject; assignments would have you skipping around a lot, both in cases and materials and in the dense notes (and I know everyone hates that). The book contains a lot of material of historical significance and interest, but there is much more than can be covered in a three-unit class. It's a great reference volume to have if you practice in the field.
There will be a traditional final examination, which will comprise the remaining 60% of your course grade. The exam will be shorter than my prior exams, which comprised 85% of the course grade.
If you have any questions, please get in touch. I am available either by email (cohenm) or phone (565-4676), or at my office (Rm. 388, 200McA.). I look forward to exploring this fascinating (and very large) corner of the law with you. How large? It is often estimated that FDA alone regulates products that represent 25 cents of every consumer dollar spent. The National Jurist's list of the top ten areas of the law with the greatest projected future employment has included Food and Drug Law for a number of years (as well as health law, which has sometimes taken the #1 spot).
DESIRED STUDENT LEARNING OUTCOMES
By the end of the semester, each student should be able to:
Students' knowledgeable participation in-class "policy debates" on current issues and controversies will be assessed on the basis of preparation, thoughtfulness, and accurate application of the law, both when the "lead" on one or more debates or as a member of the class participating on one side or the other. The overall participation score will count for 20 percent of the course grade.
Students, in small groups, will make presentations to the class at the end of the semester on topics of interest that we have not otherwise covered in any depth. Previous classes have enjoyed both creating these presentations and learning from them. The presentations will be graded (and count for 20 percent of the final grade) on the basis of the quality of the assigned reading and in-class presentation, the overall creativity of the materials and presentation, and the thoughtfulness of the suggestions for change presented.
The rest of the grade will be based upon a final examination that will be comprised of multiple types of questions: one long-form essay requiring analysis of a problem and/or critique of a statute, regulation, or government action; short essay questions requiring application of law or suggestion for new law; and short-answer questions that might include definitions of concepts, or sections of law and regulation, covered in class. The exam will be designed to assess the extent to which each student has become familiar with the body of material covered during the semester, as well as each student’s ability to apply higher-order analytical skills to problems that arise in this area of the law.