Fall Term 1999

Joel E. Hoffman

Adjunct Professor of Law


Class Meetings :

Monday and Wednesday, 10:00-11:30 a.m.

Week 1 :

Sociopolitical Context of Food and Drug Regulation. Origins, Organizations, and Functions of FDA. Role of Other Agencies in Food and Drug Regulation. How FDA regulates. Basic Concepts and Structure of the Federal Food, Drug, and Cosmetic Act.

Week 2 :

Food (Part I) – Regulation of Food Safety: Aesthetic Adulteration; Injurious Adulteration; CGMP and HACCP; Emergency Permit Control. Safety of Food Constituents: Naturally Occurring, Added and Environmental Contaminants.

Week 3 :

Food (Part II) – Safety of Food Constituents (con’t): Food and Color Additives; Food Handling and Packaging Materials; Animal Drug Residues, Other Possible Carcinogens, and the Delaney Clause; Quantitative Risk Assessment; Pesticide Residues. Regulation of Food Identity and Quality: Food Names; Economic Adulteration; Formal Standards of Identity; Temporary Marketing Permits.

Week 4 :

Food (Part III) – Regulation of Food Identity and Quality (con’t) : Regulation of Biotechnology Products. Food Labeling: Source, Quantity, Ingredient, and Nutrition Labeling; Nutrient and Quality Descriptors. Distinguished Between Foods and Drugs: Health Claims for Foods; Dietary Supplements.

Week 5 :

Drugs (Part I) – Core Concepts of Drug Regulation: Safety; Effectiveness; "New Drug" Status. Evolution of the "New Drug" Approval System. Regulation of Drug Research. The Drug Approval Process: Overview; Expanded Access and Accelerated Approval; Special Provisions for "Biological Products.

Week 6 :

Drugs (Part II) – Generic Drugs: Abbreviated New Drug Applications; Patent Term Extensions; Non-Patent Exclusivity. Orphan and Pediatric Drugs. Regulation of Drug Availability: Prescription Status; Regulation of Over-the-Counter Drugs; Special Provisions for "Controlled Substances".

Week 7 :

Drugs (Part III) – Regulation of Drug Product Quality: Adulteration; CGMP. Regulation of Drug Labeling, Promotion, and Advertising. Regulation of Animal Drugs.

Week 8 :

Distinguishing Between Drugs and Cosmetics; Regulation of Cosmetics. Medical Devices (Part I) – Evolution of Device Regulation; Distinguishing Between Drugs and Medical Devices. The Device Regulatory Scheme: Regulation by Risk-Based Classification.

Week 9 :

Medical Devices (Part II) – The Device Regulatory Scheme (con’t): applying Current Requirements to Pre-Enactment Devices; Premarket Notification; Reclassification. Control by Premarket Approval: Implementation of Approval Requirements; Approval Criteria. Special Controls: Prescription Requirement; Distribution Restrictions; Postmarketing Surveillance.

Week 10 :

Medical Devices (Part III) – General Controls: Misbranding, Adulteration, Quality Systems Assurance, Enhanced FDA Remedial Powers. Regulation of Device Labeling, Promotion, and Advertising. Regulation of Blood, Tissues and Organs.

Week 11 :

Unfinished Business.

Week 12 :

FDA Regulation and the Practice of Medicine and Pharmacy. Regulation Industry Communications with the Professional Healthcare Community: Regulating Industry Participation in Continuing Medical Education, Dissemination of Information on "Off-Label" Uses, and Communications with Managed Care Organizations; Pharmacoeconomics Claims.

Week 13 :

FDA Enforcement: Inspection and Search Warrants; Violative Acts and the Interstate Commerce Requirements; Seizure and Injection Proceedings: Recalls; Strict Criminal Liability; Debarment. Regulation of Import and Export. The Globalization of Drug and Device Regulation: International Harmonization.

Week 14 :

Private Enforcement of Regulatory Requirements: Compelling FDA to Regulate; Tort Law and Preemption; Unfair Competition Law. Freedom of Information Act Issues. Congress and FDA: Formal and Informal Oversight.