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Full-Text Articles in Law
Reducing Unlawful Prescription Drug Promotion: Is The Public Health Being Served By An Enforcement Approach That Focuses On Punishment?, Vicki W. Girard
Reducing Unlawful Prescription Drug Promotion: Is The Public Health Being Served By An Enforcement Approach That Focuses On Punishment?, Vicki W. Girard
Georgetown Law Faculty Publications and Other Works
Despite the imposition of increasingly substantial fines and recently successful efforts to impose individual liability on corporate executives under the Park doctrine, punishing pharmaceutical companies and their executives for unlawful promotional activities has not been as successful in achieving compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) as the protection of the public health demands. Over the past decade, the Food and Drug Administration (FDA) and the Department of Justice (DOJ) have shifted their focus from correction and compliance to a more punitive model when it comes to allegedly unlawful promotion of pharmaceuticals. The shift initially focused …
Implied Certification Under The False Claims Act, Gregory Klass, Michael Holt
Implied Certification Under The False Claims Act, Gregory Klass, Michael Holt
Georgetown Law Faculty Publications and Other Works
The False Claims Act prohibits fraud by government contractors, including a contractor's false certification of compliance with the contract, statutes or regulations. In the early 1990s, some courts began holding that the act of requesting payment from the government implicitly represents such compliance for the purposes the FCA. Circuits are today split on the implied certification doctrine. This Article provides a theory of implied certification, suggests how the circuit split should be resolved and describes how contracting agencies should write contracts in light of the existing rule. There are good reasons for the implied certification rule: it is an information-forcing …