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Full-Text Articles in Food and Drug Law

Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget Oct 2014

Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget

Seattle University Law Review

Since Congress amended the False Claims Act (FCA) in 1986, the statute has evolved into a seemingly boundless weapon for enforcing other statutes and regulations applicable to every industry that accepts any form of government funding. Use of the FCA by the Department of Justice (DOJ) and by private citizens bringing actions on behalf of the U.S. government to enforce other statutes and regulations is particularly evident in the field of health care. The FCA has been utilized in actions where the allegations include off-label promotion of drugs, kickbacks, and violations of current good manufacturing practices (cGMPs) by linking the …


In Memoriam: Ralph Seeley Obscured By Smoke: Medicinal Marijuana And The Need For Representation Reinforcement Review, Aryeh Y. Brown Jan 1998

In Memoriam: Ralph Seeley Obscured By Smoke: Medicinal Marijuana And The Need For Representation Reinforcement Review, Aryeh Y. Brown

Seattle University Law Review

This Comment contends that because of the continuing legislative inability to deal adequately with this issue the courts must apply strict judicial scrutiny by way of a representational reinforcement theory to cases concerning the medicinal use of marijuana. Failure to do so perpetuates the dysfunction of the judicial and legislative process. It additionally detracts from the legitimacy of that process by fostering cynicism and contempt toward the legislature that promulgates such oppressive laws and toward the judiciary that allows their enforcement.