Hot Topics in FDA Law
Fall 2016
5397 - EVANS- 28997
Professor(s): Barbara Evans (FACULTY)
Credits: 3
Course Areas: Health Law, general consumer product safety law
Time: 1:00p-2:30p TTH
Contact:
Barbara Evans, Office BLB 214
Phone: 713-743-2993 (office) 713-446-7576 (Cell or Text)
Email: bjevans@central.uh.edu
Office Hours: T-Th 2:30 – 3:30 (after class) or other times if you have conflicts then.
Overview:
FDA-regulated products account for 25% of the gross domestic product of the
United States, so a basic understanding of FDA law is essential for any student
wishing to work in, or to represent clients in, the consumer-products sector. 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). After
providing a basic tour of FDA law, the course will turn to discussion of hot topics in
FDA law, which students will select in consultation with Professor Evans.
Grading:
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 6-9 of the semester. The midterm will cover the substantive
FDA law concepts covered during the first part of the course. 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 (12/13 at 1 pm).
Because the midterm is a graded assignment, the Office for Student Services will
assist students who have a bona fide work, healthcare, or school-related conflict
(e.g., such as an illness or a moot course competition) that conflicts with the
scheduled midterm date. Every effort will be made to select a midterm date that
works for all students, but students who nevertheless have a conflict will be able to
reschedule their midterms to a date within a week of the scheduled date, on the
same basis they would be able to reschedule a final exam.
Course Text and Materials:
 Textbook: ADAMS, COOPER, HAHN & KAHAN, EDS., FOOD AND DRUG LAW AND REGULATION (FDLI,
3rd ed. 2015).
 Statute (FDCA/21 U.S.C.) -- Access via FDA website, at
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticAct
FDCAct/default.htm
 Regulations (21 C.F.R.) -- Access via FDA website, at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
 Additional materials will be posted on Blackboard and noted in the syllabus.
Note: There are very few comprehensive textbooks in the realm of “Food and Drug” Law. This
syllabus reflects significant work on my part to compile useful academic and professional narrative,
foundational case law, the statute, regulations, and FDA resources all in one place. As I will
emphasize repeatedly throughout the course, the historical case excerpts in the supplement posted
on Blackboard are a tool to examine the statute and regulations. Read and takes notes, but DO NOT
attempt to brief these cases.
Course Objectives:
1. Understand the institutional framework and scope of authority of the U.S. Food and Drug
Administration (FDA) and its relationship to other federal agencies.
2. Learn and analyze key statutory provisions, regulations, case law, and policy governing food and
dietary supplements, cosmetics, drugs, medical devices, biologics, and tobacco.
3. Develop insight into how the agency has responded to new scientific and technological
advancements and their integration into consumer products, including biotechnology and
nanotechnology.
4. Articulate and critique the delicate balance between legal and policy actions of the FDA and the
public interest. Consider, for example, when the primary approach to regulation should simply be
the provision of information to consumers or the establishment of mandatory requirements for
industry to ensure public health and safety.
5. Identify the basis and impact of the different regulatory powers of the FDA. FDA responsibilities
encompass a broad range of oversight -- from animal and clinical trials to pre-market review to post
market monitoring of marketed products and enforcement mechanisms.
6. Develop an appreciation for the interrelationship between the substantive reach of the agency’s
powers and the procedural considerations and how administrative discretion can shape the
implementation of the statute. FDA substantive powers are affected by administrative law matters,
such as the use of rulemaking and standards for statutory interpretation.
Participation: This course provides significant opportunity for class participation and discussion. I
reserve the right to increase or decrease a student grade by 1/3 grade based on participation.
Course Schedule & Readings:
Note: This is a new course still in development. The course will survey major topics in
substantive FDA law, such as those listed below. Then, it will turn to hot topic
presentations that students themselves will develop in consultation with Prof. Evans.
The following list of substantive topics is representative, but adjustments may be
made prior to August, 2016 to ensure that the amount of material covered is
manageable and allows adequate time to delve into the fascinating hot topics in FDA
law.
(1) The FDA as a Federal Administrative Agency
Textbook: p. 1-20; 683-686; 710-top 715
Statute: FDCA 701/21 USC 371(a)-(d)(regulations and hearings) & (h)(guidance documents)
FDA website: Review the FDA Organization Chart: FDA Overview, available at
http://www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/ucm393155.htm
2
(2) Food, Drug, and Cosmetic Act (FDCA) Structure & Definitions
Blackboard: Cases and Materials Supplement S2-S24
Statute: FDCA 201/21 USC 321(f)- (i), (p), (s), (t), (ff), (rr) (various definitions)
Hereinafter, all statutory references will first list the FDCA section (with the section in brackets, e.g.,
[201], if the USC subsections conform identically) followed by a slash and then the USC section.
(3) FDA Enforcement -- Scope, Inspections, Agency Correspondence & Recalls
Textbook: p. 727-top 762
Statute: [301]/331(a)-(g), (k)(Prohibited Acts)
Blackboard: Cases and Materials Supplement bottom S133-S146
(4) FDA Enforcement-- Seizures, Injunctions, & Civil Penalties
Textbook: p. 762-middle 776
Statute:
 [302]/332 (Injunction Proceedings)
 [304]/334(a)(1)(Seizure)
 [303]/333(a)-(c), (f), (g)(Penalties)
 [307]/335b (Civil Penalties)
Blackboard: Cases and Materials Supplement S147-S171
(5) FDA Enforcement -- Criminal Proceedings
Textbook: p. 776-790
Statute: 306/335a(a)-(c)(Debarment)
Blackboard:
 Cases and Materials Supplement S172-S186
 FDLI, Food and Drug Policy Forum, Are Misdemeanor Prosecutions under the Park Doctrine
an Effective Mechanism for Deterring Violations of the Federal Food, Drug and Cosmetic Act?,
July 26, 2011, p. 2-6.
(6) Introduction to Food & Basic FDCA Concepts
Textbook: p. 21-middle 42
Blackboard: Cases and Materials Supplement S34-S52
FDA website: Food, available at http://www.fda.gov/Food/default.htm
Statute:
 [401]/341 (Definitions and Standards for Food)
 [402]/342(a) &(b) (Adulterated Food)
 [406]/346 (Tolerances for Poisonous Ingredients in Food)
(7) Food Ingredients & Food Additives
Textbook: p. bottom 53-middle 69
Blackboard: Cases and Materials Supplement top S53-S64
Statute:
 [201]/321(s)(Food Additive Definition)
 [409]/348(a) & (b)(Unsafe Food Additives)
Regulations [SKIM!]: 21 CFR 110 (GMPs)
(8) Food Contact Substances
Textbook: 117-135
3
Blackboard: Cases and Materials Supplement S65-S71
(9) Food Labeling
Textbook: p. 93-115
Statute:
 [201]/321(k)-(m)(Definitions)
 [403]/343(a)-(l), (q)(1)-(3), (w) (Misbranded Food)
Blackboard: Cases and Materials Supplement S25-S33
Regulations: [SKIM!] 21 CFR 101 (Food Labeling Subpart A –G); Note 21 CFR 101.4 (Food;
Designation of Ingredients); 21 CFR 101.9 (Nutrition Labeling of Food); 21 CFR 101.13 (Nutrient
Content Claims).
(10) Dietary Supplements; Structure-Function & Disease Prevention Claims
Blackboard: Hutt et al. p. 409-middle 451
Statute: [403]/343(r)(1)-(6)(Misbranded Food)
Regulations: [SKIM!] 21 CFR 101.14 (Health Claims); 21 CFR 101.93 (Dietary Supplement Claims
exemption)
(11) Structure-Function & Disease Prevention Claims, continued; Cosmetics
Textbook: p. 263-288
Blackboard: Revisit Cases and Materials Supplement S11-S15
Statute:
 [201]/321(i)(Cosmetic Definition)
 [201]/321(t)(Color Additive Definition)
 [601]/361 (Adulterated Cosmetics)
 [602]/362 (Misbranded Cosmetics)
(12) Introduction to Human Drugs
Textbook: p. 297-middle 313
FDA website: Drugs, available at http://www.fda.gov/Drugs/default.htm
Statute:
 [201]/321(g), (p)(Definitions)
 [501]/351(a)-(c)(Adulterated Drugs and Devices)
(13) Human Drugs
Textbook: p. 313-336
Blackboard: Cases and Materials Supplement S82-S93
Statute: [502]/352(a)-(f)(Misbranded Drugs and Devices)
Regulations [SKIM!]: 21 CFR 201 (Drug Labeling Subpart A –G) – read through list of subsections
(14) New Drug Approval (NDA) Process
Textbook: p. 337-middle 353
Statute:
 [503]/353(b)(Rx Drug Status)
 [505]/355(a), (b)(1)-(2)(New Drugs)
(15) New Drug Approval (NDA) Process
Textbook: p. 353-368
4
Statute:
 [505]/355(c)(1), (d)(New Drugs)
 [506]/356(a), (b) (Fast Track)
Blackboard: Rachel Sherman, et al., Expediting Drug Development — The FDA's New “Breakthrough
Therapy” Designation, 369 N. ENG. J. MED. 1877 (2013).
Regulations: [SKIM!] 21 CFR 50, 56
FDA website:
 The Investigational New Drug (IND) Application, available at
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandAp
proved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm
 The New Drug Application (NDA), available at
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandAp
proved/ApprovalApplications/NewDrugApplicationNDA/default.htm
(16) Post-Approval Obligations
Textbook: p. 368-374
Blackboard: Cases and Materials Supplement S99-S106
Statute:
 [505]/355(e) (New Drugs)
 [505]/355(k)(1)-(3), (o), (p), (r)(New Drugs)
 [505-1]/355-1(a)-(d) (REMS)
(17) Generics & the Abbreviated New Drug Application (ANDA)
Textbook: p. 375-top 405
Statute: [505]/355(j)(ANDA)
(18) Over-The-Counter (OTC) Drugs
Textbook: p. 449-470
Regulations [SKIM!]:
 21 CFR 201.66 (OTC Drug Label)
 21 CFR 330.1, 330.5, 330.10 (OTC Monograph info)
(19) Rx Drug Promotion and Marketing
Textbook: p. 409-447
Blackboard: U.S. v. Caronia, 703 F.3d 149 (2nd Cir. 2012)
(20) Biologics License Application (BLA) & Biosimilars
Blackboard: Jordan Paradise, Chapter 3: Introduction to Biologics, in THE FUNDAMENTALS OF LIFE
SCIENCES LAW: DRUGS, DEVICES, AND BIOTECH, 2nd Ed., p. 61-79 (AHLA, 2014).
Statute: 42 USC § 262
FDA website: About the Center for Biologics Evaluation and Research, available at
http://www.fda.gov/AboutFDA/CentersOffices/CBER/default.htm
(21) Medical Devices – Classifications & the 510(k) Process
Textbook: p. 553-middle 567
Blackboard: Cases and Materials Supplement S107-S119
Statute:
 513/360c(a) & (f)(Classification of Devices)
5
 513/360c(i)(Classification of Devices, Substantial Equivalence)
Regulations [SKIM!]: 21 CFR 807.87 (Information Required in a Premarket Notification)
FDA website: About the Center for Devices and Radiological Health, available at
http://www.fda.gov/MedicalDevices/default.htm
(22) Medical Devices – Pre-Market Approval (PMA) Process
Textbook: p. 567-top 589
Statute: 515/360e (Premarket Approval)
Regulations [SKIM!]:
 21 CFR 814 (Subparts A-H) – ONLY read through list of subsections
 21 CFR 814.20 (Application)
(23) Medical Devices –Post-Market Requirements; Combination Products
Textbook: p. 589-605; 641-658
FDA website:
 Office of Combination Products website, Overview of the OCP, available at
http://www.fda.gov/CombinationProducts/AboutCombinationProducts/default.htm
 PMOA & MOA definitions, Sections I & II, available at
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-16527.htm
Statute: [503]/353(g)(Exemptions)
(24): FDA Regulation of Healthcare Professionals
Textbook: 667-682
(25) Products Liability, State Authority & Federal Preemption
Blackboard:
 Cases and Materials Supplement S120-129
 Various preemption case excerpts:
o Riegel v. Medtronic, 128 S. Ct. 999 (2008).
o Wyeth v. Levine, 129 S. Ct. 1187 (2009).
o PLIVA v. Mensing, 131 S. Ct. 2567 (2011).
o Mutual Pharmaceutical v. Bartlett, 133 S. Ct. 2466 (2013).
(26) Tobacco Products & the Tobacco Control Act (2009)
Textbook: p. 623-665 [SKIM! and be prepared to discuss and compare the new legislation in the
general context of other regulated products]
Statute: [201]/321(rr)(tobacco product)
FDA website: Tobacco Products, available at http://www.fda.gov/TobaccoProducts/default.htm
6
7