Biotech and Pharma Law

Professor: Dr. David L. Baumer
Room: Nelson 2344
Fall of 2006
Course Syllabus
Classroom: 3210 Nelson

 First Day Assignment  Statement on Disabilities


 Week 1  Week 2  Week 3  Week 4  Week 5
 Week 6  Week 7  Week 8  Week 9  Week 10
 Week 11  Week 12  Week 13  Week 14  Week 15


 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  

More Readings

 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


Prior Tests

 1e504s05.esy.doc  1e504s05.esy.2
 fe504f04.esy.doc  2e504s05.2.esy
 1e504SSII06.tfmc.doc  2e504ssII.tfmc.doc  2e504sII.tfmc



Contacting The Professor


Office: 32-G Nelson Hall
Phone: 515-6950
Fax: 515-6943
Office Hours: Mondays and Wednesdays 10:00 am-Noon


Links of Interest


NC State College of Management
Wall Street Journal
West Publishing Company