Subject(s)
Drug Industry/legislation & jurisprudence , Drug Labeling/legislation & jurisprudence , Marketing/legislation & jurisprudence , Drug Approval/legislation & jurisprudence , Drug Industry/economics , Drug Labeling/economics , Federal Government , Humans , Legislation, Drug , Marketing/economics , United States , United States Food and Drug Administration/legislation & jurisprudenceABSTRACT
In recent years, regulatory and law enforcement authorities responsible for combating fraud and abuse have focused greater attention on the scientific research process, in particular, the process of seeking reimbursement for research costs, the process of performing clinical research, and the potential improper remuneration of researchers or research subjects. This article describes how the federal False Claims Act, which allows the government to recover treble damages plus substantial penalties from persons who knowingly submit false claims or make false statements to the government, has been used to achieve a number of multimillion-dollar settlements with research institutions. The article also discusses instances of temporary suspension of research activities at a number of prominent institutions and the investigation of illegal "inducements" or "kickbacks" provided by manufacturers to researchers and by research institutions to patients.
