Curriculum Guide · Courses

Professors Thomas Cluderay, Mark Greenwold, and Joseph Page

J.D. Practicum 1101 | 5 credit hours

This practicum course will focus on regulation of tobacco and personal-care products by the Food and Drug Administration (FDA) under the Food, Drug, and Cosmetic Act. The classroom component will utilize legislative and administrative materials as well as case law to enable students to become acquainted with the processes by which the federal government regulates tobacco and personal-care products, and to critique both the statutory framework and the performance of FDA in carrying out its administrative duties. The 2009 Tobacco Act created a new regulatory regime very different from the FDA’s existing authority to regulate other products within its jurisdiction. Examination of the agency’s initial steps to carry out this responsibility provides a chance for students to understand how a federal agency responds to a legislative mandate requiring innovative action to address a major public health problem. On the other hand, FDA’s authority to regulate personal-care products is rudimentary, and presents unique challenges when both long- and short-term risks are linked to their use and regulatory action is sought. The course will also touch on related topics such as the role of the Federal Trade Commission in the regulation of trade practices, the Freedom of Information Act, the legislative process and the interaction of federal and state regulation.

In the experiential component of the course, students will work as interns with the Campaign for Tobacco-Free Kids (CTFK) and the Environmental Working Group (EWG) on projects aimed at influencing the legislative or administrative processes, or on matters in litigation, under the supervision of attorneys connected with these organizations. (Students who have completed this course will have priority consideration if they opt to apply for the Toni Stabile Graduate Fellowship at the EWG after graduation.)

Recommended: Administrative Law; Food and Drug Law-related courses. Prerequisites: Students must complete the required first-year program prior to enrolling in this course (part-time and interdivisional transfer students may enroll prior to completing Criminal Justice, Property, or their first-year elective).

Students may not concurrently enroll in an externship or a clinic (except Street Law) or another practicum course.

Students who wish to receive credit for the Externship Seminar and a practicum course that has the same field placement may do so only if: (1) the practicum course is taken in a semester following the Externship Seminar; and (2) the student receives permission from the Assistant or the Associate Dean for Clinical Programs. To receive such permission, the student must explain in writing how the practicum course field work would serve substantially different learning goals than did their externship field placement.

THIS IS A PRACTICUM COURSE.

Students will earn 2 credits for the 2-hour weekly class, and 2 credits (requires 10 hours of field placement work) or 3 credits (requires 15 hours of field placement work), depending on the number of hours devoted to work at either the Campaign for Tobacco-Free Kids or Environmental Working Group for supervised weekly work per week, for a minimum of 11 weeks, to be arranged with the faculty members teaching the course. Thus, the total credits awarded for the course will be 4 or 5 credits. Students will have the ability to choose the credit option that best fits their schedules. All students will initially be registered for a total of 4 credits, which is the two-credit seminar plus the two-credit field placement section. Once the preregistration results are released, Leslie de Leon will contact the enrolled students to confirm the number of credits they wish to receive in the field placement and will inform the Office of the Registrar of any changes. If you enroll after the preregistration period and wish to enroll for additional field work credits, contact Leslie de Leon at ld333@law.georgetown.edu. All requests for additional field placement credits beyond the one credit that is automatically assigned must be received by 5:00 p.m. on January 17, 2014.

Note: The course will typically meet on Tuesday afternoons, but will have an additional class meeting on Saturday, January 25, 2014, from 9:00 a.m. to 1:00 p.m. On two Tuesdays later in the semester, the class will not meet, to account for the Saturday session. The classroom component of this course will be graded. The 2 or 3 credits of supervised work will be evaluated on a pass/fail basis and count toward the 7-credit pass/fail limit. Students will be allowed to take another course with pass/fail grading in the same semester as the supervised work for this course.

Students who enroll in this course will be automatically enrolled in both the seminar and practicum components and may not take either component separately. A student wishing to withdraw from the course will be withdrawn from both the seminar and field work components.