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Spring 2018
5497 Hot Topics in FDA Law - EVANS- 24527

Professor(s): Barbara Evans (FACULTY)

Credits: 4

Course Areas: Health Law 

Time: 2:30p-4:10p  TTH  Location: 111  TUII

Course Outline: This course provides a practice-oriented basic survey of the Federal Food, Drug, and Cosmetic Act, a surprisingly comprehensive federal consumer safety framework that regulates not just medical products but microwave ovens, computer screens, nanoparticles in make-up, genetically modified foods, dietary supplements and a dizzying array of other products that together account for 1 in 4 dollars spent in the U.S. economy. The course then takes a deeper look at current controversies such as FDA’s ability to block dying patients’ access to unapproved therapies; FDA’s oversight of gene editing technologies that may move into human clinical trials as early as 2017; concerns about the safety of commonly used cosmetics; FDA’s recurring collisions with the First Amendment; white collar crime in drug marketing; and other controversies yet to emerge. No prerequisites or scientific background required. This course is suitable for any student who may work in, or represent, consumer products manufacturers in the future.

Course Syllabus: Syllabus

Course Notes:   This course provides a manageable introductory survey of the major substantive topics in FDA Law, including regulation of food products, food additives, dietary supplements, cosmetics, tobacco, drugs (human and animal drugs), biologics, biosimilars, and medical devices (including genetic and diagnostic tests).  Thereafter, the course will turn to discussion of hot topics in FDA law, which students will select in consultation with Professor Evans. There is no final exam 60% of students’ grades will be based on an in-class “midterm” exam to be administered on a date to be determined, based on student input, during weeks 8-10 of the semester. The midterm will cover the substantive FDA law concepts covered during the first part of the course (see more information on page 1 of the syllabus). The other 40% of students’ grades will be based on a short (3,000 to 6,000-word) medical-journal or bioethics-journal-style paper that students will write on an FDA hot topic that they will choose in consultation with Prof. Evans. Those papers will be due on or before the scheduled final exam time at the end of the semester. No Final: 60% midterm (see syllabus) and 40% short paper due during finals period.

Prerequisites:  None, other than completion of 1L curriculum.

First Day Assignments: Quickly scan the history of FDA on pages 3 - 27 in the Hutt casebook. Then read these short articles which indicate the problems FDA had 10 years ago as it started a reform effort that is still ongoing today.

Final Exam Schedule:    

This course will have:

Satisfies Skills Course Requirement: No
Satisfies Senior Upper Level Writing Requirement: No

Experiential Course Type: no

Bar Course: No

Course Materials (10/17/2017 8:50:22 AM)

Book(s) Required

Author: HUTT
ISBN: 9781609301750
Publication Date: 12/13/2013
Publisher: WEST ACAD