Food, Drug & Safety Laws Course

Your Options for Class Papers in Seminar on Food Drug & Safety LawsY

Papers in this seminar fulfill the UC mandatory requirement for a 30-page original research paper; papers are 85% of your grade.

 Optional: For some, the papers are also useful in the national competition for the $4,000 prize (fdli.org) and publication of winners nationally. Our students often choose to submit papers to the competition in the spring; 6 UC papers have won money and publication, see the rules at http://www.fdli.org/resources/academics/h-thomas-austern-memorial-writing-competition. 

You can propose a paper topic, emailing me a paragraph explaining what you intend to cover in your 30 pages. We can and will negotiate.

Or you can select one of the following suggested possibilities. The first student to email me a selected topic can take it; first come/first served. I am very open to meeting with you to discuss your top 2 or your plan for an original paper.

[The topics below are arranged in 4 broad categories, but retain the numbers they have in Professor O'Reilly's syllabus.]

FDA Power & Role

(2) Shared and competing roles of FDA and the Office of Inspector General for Medicare policing functions in fighting drug and medical device fraud and overbilling for off-label uses.

(3) Processes used by FDA for civil money penalties – compared to other federal agencies – the practical, legal, statutory and constitutional issues

(4) FDA’s role in the death penalty use of drugs: how have courts looked at FDA before and after the July 2013 DC Circuit Cook case?

(7) FDA Meets 4th Amendment: how have recent court cases affected the FDA system of wide inspectional powers, what role has FDA Office of Criminal Investigations had, and how has the FDA assured compliance with the constitutional search protections

(9) Preemption Creep – Congress carves out some exceptions from 10th Amendment; what areas has Congress preempted from state control for FDA powers; why; and what have the courts done about the loss of state authority over local FDA-regulated products both as to state label rules, state safety related quality rules, and tort lawsuits in state civil courts

(13)  FDA’s role in end of life care & assisted suicide issues

(14)  Admissibility & Utility of FDA documents, e.g. FD-3500A, Warning Letters, inspection reports, etc. in products liability case preparation and jury trials.

Food

(1) Food epidemics, poisonings and recalls: impacts of the 1/4/11 adoption of the Food Safety Modernization Act and its new tools on the rate and seriousness of harms from food “scares”.

(6) Pesticide tolerances for residues in foods – adequacy and operation of the current system for deciding how much bug-killing is compatible with eating the foods

(11) What are the current limits of “commercial free speech” for advertisements about foods? For labels of foods? What amount of substantiation is needed and by whom must it be generated?

(12)  Labels to inform food consumers of GMO biotech constituents in their food – good or bad idea, good or bad policy, what have the FDA staff and the Congress said? How does Europe do it and what are the likely effects of such information on product sales? Who cares? Why? And should they actually care?

Medical

(5) Reuse of single-use medical devices – liability and regulatory consequences of the dirty catheter’s re-use – how the FDA and liability aspects have evolved over time

(10) FDA’s role in medical malpractice tort context – how is the FDA role relevant and when in deciding if physician had erred?

Transnational Conflict

(8) International conflicts and treaty terms for FDA offices in other nations inspecting plants in those nations; Food Safety Modernization Act provisions and July 2013 proposed rules on foreign food supplier verification, and banning the import of bad drugs or bad foods into the U.S.