Neurontin and off-label marketing

Virtual Mentor

Volumn 8, Issue 6, 2006, Pages 397-402

  Krautkramer, Christian J ^a  

^a AMERICAN MEDICAL ASSOCIATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 57049170089     PISSN: 19377010     EISSN: None     Source Type: Journal    
DOI: 10.1001/virtualmentor.2006.8.6.hlaw1-0606     Document Type: Article

References (10)

1. Beck JM, Azari ED. FDA, off-label use, and informed consent: debunking myths and misconceptions. Food Drug Law J. 1998;53:71-104.
2. Friedman M. Statement submitted for the Hearing before the Subcommittee on Human Resources and Intergovernmental Relations. Off-Label Drug Use and FDA Review of Supplemental Drug Applications. 104th Congress. September 12, 1996. Publication 44-757:62.
3. National Cancer Institute. Understanding the Approval Process for New Cancer Treatments. Available at: http://www.cancer.gov/clinicaltrials/learning/approvalprocess-for-cancer-drugs/page5. Accessed on May 14, 2006.
4. Friedman, 61.
5. 21 USC §§351, 352, 353.
6. 31 USC §3729(a).
7. Petersen M. Doctor explains why he blew the whistle. New York Times. March 12, 2003:C1.
8. United States ex rel. Franklin v Parke-Davis, 147 F Supp 2d 39 (D Mass. 2001).
9. Kaufman R. The Neurontin Controversy: The Saga of Off-Label Drug Regulation Continues. Legal Electronic Document Archive. Harvard Law School. April 2004. Available at: http://leda.law.harvard.edu/leda/data/638/Kaufman.html. Accessed May 5, 2006.
10. Warner-Lambert to pay $430 million to resolve criminal & civil health care liability relating to off-label promotion. [press release]. Washington, DC: Department of Justice; May 13, 2004. Available at: http://www.usdoj.gov/opa/pr/2004/May/04_civ_322.htm. Accessed May 14, 2006.