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The Moral Hazard Problem With Privatization Of Public Enforcement: The Case Of Pharmaceutical Fraud, Dayna Bowen Matthew
The Moral Hazard Problem With Privatization Of Public Enforcement: The Case Of Pharmaceutical Fraud, Dayna Bowen Matthew
University of Michigan Journal of Law Reform
This Article takes a law and economics approach to exploring some of the costs that arise when governments rely on private enforcement to accomplish the goals of public law. The analysis focuses on qui tam enforcement under the Civil False Claims Act, because a remarkable body of empirical data demonstrates the expansive role private qui tam relators are playing in enforcing Medicare and Medicaid fraud and abuse laws. The Article further focuses on the application of these laws to the pharmaceutical industry. This focus is enlightening because the Government, as well as private enforcers, have recently targeted this industry so …
Fda Approval Of Generic Biologics: Finding A Regulatory Pathway, Kathleen R. Kelleher
Fda Approval Of Generic Biologics: Finding A Regulatory Pathway, Kathleen R. Kelleher
Michigan Telecommunications & Technology Law Review
Biologics are becoming increasingly important for the potential treatment of widespread diseases such as cancer, anemia, and diabetes. As hundreds of biologics are going off-patent, the market has become ripe for the introduction of generic biologics. A regulatory pathway for biogenerics, however, is virtually nonexistent. The purpose of this paper is thus to analyze how a successful legislative pathway for generic biologics might be designed. The current regulatory scheme, economic concerns, health and safety concerns, and the need to provide proper incentives for innovation are analyzed. Finally, recent Congressional bills are outlined and critiqued, through which the structure of a …