Food and Drug Law
FOOD AND DRUG LAW - SPRING 2012
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, and a similar-sized addition in 2011 covered food safety). In addition it is safe to say that there are thousands of pages of regulations, guidance documents, and other important materials that practicing lawyers need to know about. There is more than enough to keep us busy for a semester. At the first class I will inquire about the interests/backgrounds of class members, and make final decisions about how much class time will be devoted to each of the fields of regulation with those interests in mind.
The core of our class materials (40-50% of our reading) will be multiple chapters from the brand-new edition of the text Food and Drug Law and Regulation. published in December 2011. 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 has offered two alternative means of access to this new book, as I have described in an email to all pre-registered students: a site license or an excellent student price for the book. If you were not pre-registered for the course, please send me an email to get the details about the book. (The book is now on FDLI's website: http://www.fdli.org/pubs/books/#fdlr.) 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 provided either here or at one of the course portals. Each student will be able to decide what/how much to print or to read electronically.
In addition to the traditional final examination, there will be a required project to be done in small groups (with group sizes dependent upon course registration). Each group will pick a subject of interest to explore, learn about, and then teach to the class at the end of the semester. The group projects will comprise 15 percent of the course grade.
A more "formal" presentation of course information is below.
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 (a "corner" that is estimated to represent 25 cents of every consumer dollar) with you.
Marsha Cohen
DESIRED STUDENT LEARNING OUTCOMES
By the end of the semester, each student should be able to:
- Understand the historical background from which evolved each of the major branches (food, drugs, medical devices, cosmetics, tobacco) of the Food and Drug Administration’s regulatory authority.
- Be able to articulate how the federal government exerts regulatory control over food, drugs, medical devices, cosmetics, and tobacco and understand the similarities and differences in how that regulatory control is exerted.
- Appreciate the impact of regulatory control on the costs of bringing products to market as well as the risks of allowing products to be marketed with a lesser level or other type of regulatory control.
- Identify several current regulatory policy controversies with respect to regulation of products by the FDA, and have reached at least a tentative personal conclusion about the best approach to each controversy.
- Recognize the areas of constitutional controversy that relate to FDA regulation and understand how case law has to date resolved (or not resolved) that controversy.
- Understand sufficiently the details of complex statutory and regulatory provisions (such as the patent provisions governing generic drug approval) to solve specific problems requiring their application.
- As part of a group sharing a common interest, research and study an issue not otherwise covered in class that involves FDA or other regulatory agency control, create a set of reading materials about that issue to provide background to your classmates, and make a class presentation about that issue.
ASSESSMENT:
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 15 percent of the final grade) on the basis of the quality of assigned reading, the quality of the in-class presentation, and the overall creativity of the materials and presentation.
The rest of the grade will be based upon a final examination that will be comprised of multiple types of questions: one or more long-form essays 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.
SYLLABUS: The syllabus for this course in 2011 is below, for your information.
|
DATE/SUBJECT |
FDLR |
STATUTES |
OTHER |
|
(1) 1/10 Overview |
1-16 |
§ 321 (pp. 1-4), esp. subsections (f), (g), (h), (i), (p), (s), (ff), (rr) |
-- |
|
(2) 1/12 What is a Drug? Drug or Device? |
281-291 |
Review definitions as needed |
US v. Bacto-Unidisk; US v. Ova II |
|
(3) 1/13 Drug or Food? Drug or Cosmetic? |
-- |
Review definitions as needed |
NutriLab v. Schweiker; US v. Sudden Change; FDA v. Brown & Williamson; regulation on “intended uses” |
|
NO CLASS 1/17 |
|||
|
(4) 1/19 Prohibitions, Adulteration, and Misbranding; Drug Imports/Exports |
291-315 |
§§331, 351-352, 384 |
US v. Barr Laboratories; excerpt on Import/Export Consider: (1) If you are representing a company struggling to be certain it is in compliance with GMPs – or certain its procedures are better than those in GMPs – what options do you have? (2) What are the benefits and risks of drug reimportation? Are there options that will reduce drug prices in the United States? |
|
(5) 1/20 New Drug Approval: the IND |
317-320 |
§355(a), (i) |
Weinberger v. Hynson, Westcott & Dunning; US v. Generix Drug Corp. |
|
(6) 1/24 New Drug Approval: the NDA |
320-352 |
§355(b)-(h)
|
FDA Special Report: Protecting America’s Health Through Human Drugs (for additional background or review of the drug approval process) Do you see any problems in the drug approval process (either in the statutory framework or in its implementation)? If you were Commissioner or a legislator, would you suggest any changes? |
|
(7) 1/26 Generic Drugs and Patent Law Issues |
353-359 |
In tandem with the reading for today and 1/27, read §355(j) – pp. 38-47 – that is not a typo; this is one lengthy and complex section. |
We will spend 3 classes untangling the complicated legal web surrounding the approval of generic drugs. A legislative “deal” made approval of generics simpler and more efficient in return for patent law changes. |
|
(8) 1/27 – Generic Drugs and Patent Law Issues (continued) |
359-377 |
Also read Patent Act excerpts, pp. 88-92 |
Along with many details, we will consider the “big picture”: was the “deal” a good one? are there any “fixes” you would suggest? |
|
(9) 1/31 Generic Drugs and Patent Law Issues (continued) |
377-382 |
§355a (pp. 56-57) |
-- |
|
(10) 2/2 Post-Marketing; Prescription Drug Promotion |
383-411 |
§§355b, 356. 356-1, 358 (mentioned but not previously assigned); §§356b, 356c, 355(k)-(t), 355-1 |
Washington Legal Foundation v. Henney; Guidance for Industry: Good Reprint Practices for the Distribution of Medical Journal Articles ... (Jan. 2009). |
|
(11) 2/3 Promotion to Prescribers, Direct-to-Consumers; OTC Drugs |
413-32 |
§§352(x) (previously assigned), 353(b), 379aa |
Skim Warning Letters to makers of Celebrex, Cymbalta, Plavix, Levitra & Yaz; FDA Aims at Doctors’ Drug Pitches (NY Times); Drug Marketing Issues |
|
(12) 2/7 Biologics |
433-453 |
Public Health Service Act §§262 and 264 (pp. 92-98); substitute revised §262(i) |
-- |
|
(13) 2/9 Biologics |
453-486 |
-- |
Berkovitz v. United States |
|
(14) 2/10 Biologics |
-- |
-- |
Biogenerics materials |
|
(15) 2/14 Medical Devices |
487-534 |
BUT NOTE OMIT: 502-504 (to last para), 507-510, 528-530, 534-536. *********************** §§ 360, 360c, 360e, 360j, and 360l |
PRESENTATION DEADLINE: to form groups and report general idea. |
|
(16) 2/16 Medical Devices |
-- |
-- |
Group of New York Times stories from 2009-2011 (citations posted) |
|
(17) 2/17 Food Safety: Introduction |
17-27 |
§§342, 350f |
Chap. 3, The Changing Nature of Food Hazards: Cause for Increasing Concern, in Ensuring Food Safety from Production to Consumption (National Academies Press 1998) (available online at http://books.nap.edu/openbook.php?record_id=6163&page=51); US v. Lexington Mill & Elevator Co.; Continental Seafoods v. Schweiker *** MAKE AN APPOINTMENT FOR NEXT WEEK (signup sheet will be available in class) |
|
NO CLASS 2/21 |
|||
|
(18) 2/23 Food Safety: Contaminants and Additives |
28-43 |
§§321(s), 334, 346, 348 |
US v. 298 Cases (Ski Slide Brand Asparagus), Young v. Community Nutrition Institute, FDA information on defect action levels
PRESENTATION MEETINGS: to discuss your idea(s) and refine your topic. |
|
(19) 2/24 Food Safety: Food Additives |
44-56 |
-- |
US v. An Article of Food (Coco Rico), Monsanto v. Kennedy |
|
(20) 2/28 Food Safety: Carcinogens, Pesticides; passage of FDAFSMA |
56-76 |
§346a (posted) |
Compliance Policy Guide §575.100 http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm123236.htm (skim this page online); brief history of passage of FDAFSMA (article handed out in class); Michael Taylor, Deputy Commissioner for Foods, speech on FDAFSMA (http://www.fda.gov/AboutFDA/CentersOffices/OC/OfficeofFoods/ucm241192.htm) |
|
(21) 3/2 FDA Food Safety Modernization Act |
-- |
FDA Food Safety Modernization Act (excerpts) (posted) |
Food Safety Act articles |
|
(22) 3/3 More FDAFSMA; Food Labeling Basics |
77-86, 100 |
review §§ 321(k)(m)(n); 343(a)-(j), (w),(x) |
-- |
|
SPRING BREAK |
|||
|
(23) 3/14 Food Safety and Labeling of Biotech Products; Nutrition Labeling Overview |
review49-52,67-68; 87-93 |
-- |
FDA’s Position on Labeling of Genetically-Engineered Foods; Biotech Animals |
|
(24) 3/16 |
93-101 |
§ 343(q),(r)(pp. 13-21) |
-- |
|
(25) 3/17 “Qualified” Health Claims |
-- |
-- |
The Pearson v. Shalala litigation (and First Amendment issues)
|
|
(26) 3/21 Preemption of State Regulation/ State Tort Claims |
-- |
§§379r, 360k |
Dowhal v. Smithkline Beecham Consumer Healthcare; Riegel v. Medtronic |
|
(27) 3/23 Preemption of State Tort Claims |
-- |
-- |
Wyeth v. Levine |
|
(28) 3/24 Preemption of State Tort Claims: The Current Case |
-- |
BE PREPARED TO ARGUE THE CASE: (Students were assigned to be Petitioners or Respondents) |
Read either Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009) or Demahy v. Actavis, 593 F.3d 428 (5th Cir. 2010). (I have not edited or posted either decision.) Read either the Petitioner’s or the Respondent’s brief (as assigned) in Pliva v. Mensing (the lead case among three consolidated on this same issue). [Note: the Respondent’s brief printed half-size at Hastings – you might want to preview the documents before hitting the print button.] The cases will be argued before the Supreme Court on March 30. |
|
(29) 3/28 Dietary Supplements |
169-193 |
§§321ff, 343(s), 350, 350b |
-- |
|
(30) 3/30 Dietary Supplement Claims |
193-211 |
§§342(f), (g), 343-2, 379aa-1 |
-- |
|
(31) 3/31 Dietary Supplements: Enforcement |
-- |
-- |
Nutraceutical Corp. v. Von Eschenbach |
|
(32) 4/4 Cosmetics/Animal Drugs (just the basics: primarily lecture) |
-- |
§§ 321(i), 361-362; §360b |
Termini and Tressler, American Beauty: An Analytical View of the Past and Current Effectiveness of Cosmetic Safety Regulations and Future Direction, 63 Food & Drug L.J. 257 (2008) (available in Lexis/Westlaw/HEIN Online); Animal drugs materials assigned from FDA website (see posted links) |
|
(33) 4/6 Animal Drugs/Tobacco |
-- |
§§ 387, 387a-t (pp. 76-88) |
-- |
|
(34) 4/7 Tobacco: FDA’s Newest Responsibility |
-- |
-- |
Tobacco materials assigned from FDA website (see posted links); Mathew R. Herington, Tobacco Regulation in the United States: New Opportunities and Challenges, 23 Health Lawyer 13 (Oct. 2010). |
|
(35) 4/11 Administrative Proceedings and “Leftover” Sections |
587-634 |
§§ 371. 372, 374, 375 “Leftover” (never assigned) FDCA sections to skim: §§ 341, 343-1, 353(g), 353b, 355c, 355e, 360bbb, 360bbb-3, 378, 379h, 381, 393, 396 |
-- |
|
(36) 4/13 Enforcement Issues |
635-688 |
§§ 332-335, 335b, 336-337, 379a |
-- |
|
(37) 4/14 |
-- |
Presentations* |
|
|
(38) 4/18 |
-- |
Presentations* |
|
|
(39) 4/19 |
-- |
Presentations* |
|
|
*materials to be provided in advance |