FEDERAL ENFORCEMENT ACTIONS AGAINST FRAUD AND ABUSE BY PHARMACEUTICAL MANUFACTURERS- 1996- 2010

Author(s)

Qureshi Z1, Sartor O2, Bennett C11University of South Carolina, Columbia, SC, USA, 2Tulane University, New Orleans, LA, USA

OBJECTIVES: To expand on the scope of the limited prior research by reporting on concluded investigations involving pharmaceutical manufacturers independent of whether or not they involved qui tam relators between 1996-2010. METHODS: All cases involved pharmaceutical manufacturers and FCA violations, which impose liability of up to triple damages and civil penalties of $5,500 to $11,000 per claim for submitting false claims to the government.  Data were from Department of Justice during 1996-2010. RESULTS: Since 1996, resolution of 31 FCA cases involving pharmaceutical manufacturers accounted for $12 billion in recoveries. Total recoveries were $8 million during 1996-2000 (one case), $3.9 billion during 2001-2005 (15 cases), and $8.1 billion during 2006- 2010 (15 cases). Billing fraud was implicated in 18 cases ($3.7 billion), off-label marketing in 12 cases ($4.4 billion), kick-backs in 5 cases ($1.7 billion), and producing defective pharmaceuticals in one case ($750 million). Qui tam relators initiated 77% of the cases (median reward $31 million). Six settlements included criminal fines. CONCLUSIONS: With expansion of government healthcare, fraud investigations of pharmaceutical manufacturers will undoubtedly continue.  These investigations have the potential to reduce costs and improve the quality of pharmaceutical use.

Conference/Value in Health Info

2011-05, ISPOR 2011, Baltimore, MD, USA

Value in Health, Vol. 14, No. 3 (May 2011)

Code

PHP3

Topic

Patient-Centered Research

Topic Subcategory

Patient Behavior and Incentives

Disease

Multiple Diseases

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