BUS 590

Readings: BUS 590 O: Biotech Pharma Law	Off-Label Use and Product Liability.ppt	Dr. Roger Nolan: FDA Approvals	HIPAA: Baumer, Earp, and Payton	Online Distribution of Drugs: Steve Schanz
Week 12	Week 12. a	Week 12. b	Week 12. c

Week 11:	Overview of Drug Regulation	Consumer Protection: Regulation of Physical Product, Baumer	History of the FDA The 1906 Food and Drugs Act The 1938 Food, Drug, and Cosmetic Act	Drugs and Foods Under the 1938 Act and its Amendments Laws Enforced by the FDA and Related Statutes
Week 12:
Week 13:	The Prescription Drug Marketing Act	Scheineson.Klinger: Lessons from Expanded Govt. Enforcement Efforts Against Drug Companies	Fee for Service: Distribution of Pharmaceuticals.Baumer
Week 14:	Prescribing a Cure for Online Pharmacies, Ayres	Distribution of Pharmaceutical Drugs: Baumer, Earp, Poindexter
Week 15:	The Inadequacy of HIPAA's Privacy Rule: The Plain Language Notice of Privacy Practices and Patient Understanding, Pollio	The Privacy of Medical Records: IT Implications of HIPAA, Baumer, Earp, Payton	HIPAA Regulation: Comprehensive

Week 11	Expert Witness, 289 F.3d 1193	Premption, 231 F.3d 216	Ephedra.enforcement, 2006 U.S. App. LEXIS 21066
Week 12	First.Amend. 36 F. Supp. 2d 16	Limits of FDA Authority, 318 F.3d 92	Food Additive, 987 F.2d 33
Week 13	Learned Intermediatory 271 F.3d 89	DirectToConsumer,734 A.2d 1245	Prescription.Drug.Marketing Act, 401 F.3d 53
Week 14	Online Dispensing 272 Kan. 1313	Online Prescriptions 72 Fed. Appx. 837	Indictment for Online Sales
Week 15	Doe v. Septa, 72 F.3d 1133	HIPAA.Application, 428 F.3d 167	HIPAA.Abortion, 362 F.3d 923