Food and Drug Law
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, and 140 pages amending and adding user fees passed in July 2012). 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 second 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 made available a reasonable student price, discounted further for bulk orders, as I have described in emails to all pre-registered students. (The book is 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 on the Hastings Blackboard website, to which I will provide a link at the beginning of classes. 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 final course registration). Each group will pick a subject of interest 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 statute or a suggestion for change by government or industry to the issues involved. 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 the issue that includes some suggestion for change by government, industry, or consumers.
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 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 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.
THE SYLLABUS:
Each year the course changes somewhat, in response to the interests of the students in the class, current "hot" topics, and newly-passed legislation. One hot topic worth covering this year, for example, is the regulation of pharmacy compounding -- which involves the First Amendment, you may be quite surprised to learn.
I have pasted below the syllabus for the 2012 class, for your interest in seeing what was covered. The 2013 syllabus will "grow" during the course of the semester, and will be updated on the Blackboard course site.
|
DATE/SUBJECT |
FDLR |
STATUTES |
OTHER |
|
(1) 1/9 Overview |
1-21 |
§ 321 (pp. x-y1-4), esp. subsections (f), (g), (h), (i), (p), (s), (t), (ff), (rr) |
-- |
|
(2) 1/11 What is a Drug? Drug or Device? |
-- |
Review definitions as needed |
US v. Bacto-Unidisk; US v. Ova II; NutriLab v. Schweiker; US v. Sudden Change |
|
(3) 1/12 Drug or Food? Drug or Cosmetic? |
TBA |
Review definitions as needed |
FDA v. Brown & Williamson; regulation on “intended uses” |
|
1/16 MLK, Jr. HOLIDAY |
|||
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(4) 1/18 Drugs: Prohibitions, Adulteration, and Misbranding |
317- 348 |
§§331(a)-(ii), 333(a)-(b), 334(a), 351-352 |
US v. Barr Laboratories Consider: 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? |
|
(5) 1/19 New Drug Approval: the IND; Drug Imports/Exports |
355-358, 348-353 |
§355(a), (i) |
Weinberger v. Hynson, Westcott & Dunning; US v. Generix Drug Corp.; excerpt on drug imports/exports. Consider (policy question): What are the benefits and risks of drug reimportation? Are there options to reduce drug prices in the United States? What would you recommend to policymakers on this issue? |
|
(6) 1/23 New Drug Approval: the IND and the NDA |
358- 392 |
§§355(b)-(h), 356, 356-1, 358 |
If you need more information about aspects of the drug investigation and approval process, look at the relevant parts of FDA Special Report: Protecting America’s Health Through Human Drugs, which was prepared for consumers (www.fda.gov/Drugs/ ResourcesForYou /Consumers/ucm143455.htm). Consider: what problems do you see 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) 1/25 Generic Drugs and Patent Law Issues |
393-399 |
In tandem with the reading for today and 1/26, read §355(j), pp. 45-54 – 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 possible without sponsors needed to do clinical trials; in return pioneer sponsors received patent term extension. |
|
(8) 1/26 Generic Drugs and Patent Law Issues (continued) |
399-417 |
Patent Law excerpts: pp. 96-99 |
In today’s and Monday’s classes, David Schwab ’11 will help you walk through the incredible complexity of the statutory scheme that incorporates the “deal.” |
|
(9) 1/30 Generic Drugs and Patent Law Issues (continued) |
417- 423 |
§355a (Pediatric studies of drugs) |
Along with many details (and don’t panic: they will get clarified), consider: was the “deal” a good one? what fixes, if any, would you suggest? |
|
(10) 2/1 More Drug Statutes … |
-- |
§§355(k)-(t), 355-1, 355b, 355e, 356b, 356c, 379h |
Most of the sections assigned today are relatively new to the statute: do some of them offer significant benefits to us as drug consumers? Which one(s) would you have sponsored as a member of Congress? Anything missing that ought to be part of the regulatory framework for drugs? |
|
(11) 2/2 Prescription Drug Promotion and Marketing |
425-459 |
-- |
Is prescription drug advertising helpful? Harmful? Offensive? Last names A-L: be prepared to report on at least one TV Rx drug ad -- M-Z: on at least one Internet Rx drug ad or promotion. Should there be any limits on promotion to prescribers? What about by prescribers? Read FDA Aims at Doctors’ Drug Pitches; U.S. to Force Drug Firms to Report Money Paid to Doctors http://tinyurl.com/72dnfea. |
|
(12) 2/6 OTC Drugs |
461-483 |
§352(x)(previously assigned), 353(b), 379aa |
Consider any OTC drug you have at home (or borrow one!). Would you change the label or labeling in any way? Could a greater percentage of our drugs be safely switched to OTC? (Would that be economically beneficial?) |
|
(13) 2/8 Biologics |
485- 509 |
Public Health Service Act §262 (pp. 99-105) |
Berkovitz v. United States |
|
(14) 2/9 Biologics/Bio- Similars |
509- 538 |
-- |
-- |
|
(15) 2/13 Biologics/Bio- similars |
538- 567 |
-- |
FDA does not appear to have met its “promise” of issuing guidance by the end of 2011. If you are giving advice to biologics companies (either makers of pioneer or biosimilar products), what would you like to know? But FDA did issue guidance, on February 9, just in time for this class! See short class handout (also posted). |
|
(16) 2/15 Medical Devices |
569-605* |
*See course materials for list of text sections to omit §§360. 360c, 360d, 360e, 360j, 360l |
PRESENTATION DEADLINE: to form (and report) groups and report general idea of presentation subject |
|
(17) 2/16 HASTINGS MONDAY Medical Devices |
605-620* |
*See course materials for list of text sections to omit |
Two sets of newspaper stories, from The New York Times and The Washington Post. |
|
2/20 PRESIDENTS DAY HOLIDAY |
-- |
||
|
(18) 2/22 Food Safety: Scope of the Problem, New FDA Authority |
24-37 |
§§342, 350d, 350f, 350g, 350h, 350l and 2223 (found on pp. 34-35 of the statutes) |
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); Food Safety Modernization Act Progress Report and speech by Michael Taylor of FDA (posted) APPOINTMENTS TO DISCUSS PRESENTATION IDEAS |
|
(19) 2/23 Food Safety: Contaminants and Adulterants |
37-58 |
§§334, 346 |
US v. Lexington Mill & Elevator Co., Continental Seafoods v. Schweiker, US v. 298 Cases (Ski Slide Brand Asparagus), Young v. Community Nutrition Institute, FDA notice on defect action levels and excerpts from handbook |
|
(20) 2/27 Food Safety: Food Ingredient Regulation |
58-76 |
§§321s, 348 |
US v. An Article of Food (Coco Rico), Monsanto v. Kennedy. May a substance that has long been recognized as safe (GRAS) have that status revoked or modified? What if that substance is sugar? or sodium? |
|
(21) 2/29 Food Safety: Carcinogens and Pesticides |
76-86, 91-100 |
§346a (posted) |
Compliance Policy Guide §575.100 http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm123236.htm (skim this page online); read about the fungicide carbendazim in imported orange juice: www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVegetablesJuices/ucm288004.htm - read cover page and, below, under “additional information,” read Questions & Answers: Carbendazim and Orange Juice Products, Blog: Why Your Orange Juice is Safe, and EPA: Risk Assessment for Safety of Orange Juice Containing Fungicide Carbendazim. Is the US statutory framework in this area sufficient for consumer protection? What problems might you anticipate in implementation of our laws? |
|
(22) 3/1 Food Safety: New Technologies (Biotech, Nanotech) |
86-91 |
-- |
FDA’s Position on Labeling of Genetically-Engineered Foods; articles on Biotech Animals; International Dairy Foods Association v. Amestoy – and if the salmon decision is made, find a read a news story about it. |
|
SPRING BREAK |
|||
|
(23) 3/12 Food Labeling Generally |
101-12, 118-26 |
review §321(k),(m),(n); §343(a)-(j) |
-- |
|
(24) 3/14 Nutrition Labeling and Health Claims |
112-18 |
§ 343(q),(r) (pp. 14-22) |
-- |
|
(25) 3/15 Health Claims; Preemption Issues |
-- |
Preemption: §§360k(a), 379r; review text pp. 340, 431, 434-35, 444, 477, 618-620 |
Health claims: the Pearson v. Shalala litigation and First Amendment issues |
|
(26) 3/19 Preemption (Drugs) |
-- |
-- |
Dowhal v. Smithkline Beecham Consumer Healthcare, Wyeth v. Levine, Pliva v. Mensing, Conte v. Wyeth |
|
(27) 3/21 Preemption (Medical Devices) |
-- |
--
|
Medtronic v. Lohr, Riegel v. Medtronic GUESTS: Jack B. McCowan, Jr., a partner at Gordon & Rees who teaches personal injury litigation at Hastings, and associate Rebecca Wardell, Hastings Class of 2010, will talk about preemption in the real world of medical device litigation. |
|
(28) 3/22 Dietary Supplements |
201-225 |
§§321ff, 343(s), 350, 350b; reread §343(r)(6) |
-- |
|
(29) 3/26 Dietary Supplements |
226-246 |
§§342(f), (g), 343-2, 379aa-1 |
-- |
|
(30) 3/28 Dietary Supplements |
-- |
-- |
Excerpts from Soller et al., The Regulated Dietary Supplement Industry: Myths of an Unregulated Industry Dispelled; Dangerous supplements: What you don't know about these 12 ingredients could hurt you, Consumer Reports, September 2010 GUEST: Dr. William Soller, UCSF School of Pharmacy |
|
(31) 3/29 Cosmetics (just the basics/mostly lecture) |
-- |
§§ 321(i), 361-362
|
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) |
|
(32) 4/2 Animal Drugs |
-- |
§360b |
THIS WEEK: Presentation handouts due. Read the FDA web pages assigned (links provided on Blackboard). |
|
(33) 4/4 Animal Drugs; Tobacco Products |
659-667 |
-- |
Animal Drugs: Please read the assigned New York Times article and Natural Resources Defense Council v. FDA. The just-issued NRDC case is not edited, and it is long; don’t worry about the details: it is presented in full because it is of current interest, and also is a nice recap/reminder of the process of judicial review of statutes and administrative action. |
|
(34) 4/5 Tobacco Products |
667- 704 |
§§ 331(oo)-(uu), 387, 387a-t |
-- |
|
(35) 4/9 “Leftover Statutes”; Administrative Proceedings |
-- |
“Leftover” (never assigned) FDCA sections to skim: §§ 331(vv), 341, 343-1, 353(g), 353b, 360bbb, 360bbb-3, 378, 381, 384, 393, 396 §§ 371. 372, 374, 375 |
THIS WEEK: Presentations (slides, etc.) due FDLR has chapters on administrative proceedings (Ch. 21) and enforcement issues (Ch. 22) but they are not assigned reading. The assigned reading for this class and the next is just some relevant statutory sections. |
|
(36) 4/11 Enforcement Issues; Wrapup** |
-- |
**Please bring your laptop so we can do the PACE evaluation |
-- |
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(37) 4/12 |
-- |
Presentations |
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(38) 4/16 |
-- |
Presentations |
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(39) 4/17 HASTINGS |
-- |
Presentations |
UCHastings College of the Law
200 McAllister, San Francisco, CA 94102415.565.4600
