Legal and economic perspectives concerning US government investigations of alleged off-label promotion by drug manufacturers

PharmacoEconomics

Volumn 27, Issue 8, 2009, Pages 623-625

  Kalb, Paul E ^a   Greenberg, Paul E ^b  

^a SIDLEY AUSTIN LLP   (United States)

^b ANALYSIS GROUP   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL DECISION MAKING; CLINICAL MEDICINE; CLINICAL STUDY; DRUG INDUSTRY; ECONOMIC ASPECT; EDITORIAL; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HEALTH CARE COST; LEGAL ASPECT; MEDICAID; MEDICAL INFORMATION; MEDICARE; PHYSICIAN; PRESCRIPTION; PRIORITY JOURNAL; PUBLIC HEALTH; UNITED STATES;

DRUG APPROVAL; DRUG INDUSTRY; DRUG LABELING; FEDERAL GOVERNMENT; HUMANS; LEGISLATION, DRUG; MARKETING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 69749104985     PISSN: 11707690     EISSN: 11792027     Source Type: Journal    
DOI: 10.2165/11315660-000000000-00000     Document Type: Editorial

References (7)

1. United States Government Accountability Office. Report to the Ranking Member, Committee on Finance, US Senate. Prescription drugs: FDA's oversight of the promotion of drugs for off-label uses. GAO-08-835. July 2008 [online]. Available from URL: http://www.gao.gov/new.items/d08835.pdf [Accessed 2009 Jul 13]
2. Winslow R. Pfizer sets $2.3 billion settlement: agreement with US tied to alleged off-label marketing of painkiller Bextra. Wall Street J 2009 Jan 27 [online]. Available from URL: http://online.wsj.com/article/ SB123301757444517869.html [Accessed 2009 Jul 13]
3. Boos J. Off label use: label off use? Ann Oncol 2003; 14 (1): 1-5
4. Poole SG, Dooley MJ. Off-label prescribing in oncology. Support Care Cancer 2004; 12 (5): 302-305
5. Soares M. Off-label indications for oncology drug use and drug compendia: history and current status. J Oncol Practice 2005 Sep; 1 (3): 102-105
6. United States Government Accountability Office. Report to the Chairman, Committee on Labor and Human Resources, US Senate. Off-label drugs reimbursement policies constrain physicians in their choice of cancer therapies. GAO/PEMD-91-114 September 1991 [online]. Available from URL: http://archive.gao.gov/d18t9/144933.pdf [Accessed 2009 Jul 13]
7. Spivack PS. Off-label promotion under scrutiny by DOJ: the Department of Justice is aggressively pursuing healthcare fraud allegations. Gen Eng Biotech News 2008 Jun 1; 28 (11):