Regulation of Food and Drugs

Catalog description

The Course will strive provide (1) an understanding both the black letter of food and drug law and the underlying policies and themes of our system of food and drug regulation, (2) the opportunity to ponder on the material at a deeper level, thinking about food and drug law's role in our society and your views on the key public policy issues, and (3) a few practical skills relating to an administrative practice in food and drug law. Topics that will be discussed include an overview of the FDA and its Organization, FDA's History, Politics and the FDA: Contraception, Regen, Zohydro, and User Fees, Statutory Overview and Definitions, Enforcement Actions/Prohibited Acts, Medical Product Development including o Preclinical Issues: Animal Use, GLP o INDs and IDEs o Legal and Ethical Issues in Human Trials - IRBs and informed consent o Special Issues in First Use in Humans o Harmonization and International Trials Pharmaceutical and Biotech Industry, Drug Approval Process: NDA, Vioxx and FDAAA, Post-Approval Surveillance, Postmarket Safety Authorities (REMS, Safety Labeling Changes, Post-Market Requirements), Market Exclusivity Schemes: Orphan Drug Act, GAIN, and Others Hatch-Waxman and Generics, Patents versus Regulatory Exclusivity, Labeling, Product Liability and Preemption, Prescription Drug Promotion and the First Amendment, Access to Unapproved Products, FDA's regulations and statutory authority, Access Litigation - Rutherford & Abigail Alliance, Right-to-Try statutes, GMPs & Drug Shortages, OTC Drugs, Biologics, in general, Case study - the early 2000's policy fight over embryonic stem cells and cloning, The Med Tech Industry/Introduction to Devices, Device Classifications and Marketing Authorizations, Frontier Issues: Mobile Apps & Preview of Genetic Testing (DTC and LDTs), Pharmaceutical pricing and The Future of the FDA, Drugs, Biologics, and Devices.