id	author	title	date	pages	extension	mime	words	sentence	flesch	summary	cache	txt
ihlr-2018	McCreary Eichel, Kristin	Focusing on Fraud: The Federal Government Expands Its Use of the False Claims Act to Police Off-Label Pharmaceutical Promotion	2011	36	.pdf	application/pdf	15958	763	54	Although many other pharmaceutical manufacturers have settled claims involving off-label drug promotion recently, the magnitude of the Pfizer settlement demonstrates the seriousness of the federal govern- ment’s enforcement efforts and its commitment to change this widespread behavior.14 The sources of federal law that served as the basis for Pfizer’s off- label marketing liability were the Federal Food, Drug, and Cosmetic Act (“FDCA”) and the False Claims Act (“FCA”).15 While the FDCA has tradi- tionally been used to regulate illegal off-label marketing behavior, the use of the FCA as an additional legal tool to police the same behavior has only recently emerged.16 Attaching FCA liability to off-label marketing has not only made it possible for the Department of Justice (“DOJ”) to pursue the pharmaceutical industry for putting the public’s health at risk, but it has now permitted the DOJ to pursue the pharmaceutical industry with a justifi- cation that it is protecting the American taxpayers from health care fraud.17 The DOJ is no exception in its recent enforcement efforts under the FCA; in fact, all three branches of federal government have embraced this new theo- ry of off-label promotion liability and have played some role in expanding the scope of the FCA. See Pfizer Press Release, supra note 2. 2011] FEDERAL GOVERNMENT EXPANDS ITS USE OF THE FALSE CLAIMS ACT 423 within the off-label context.173 Many FCA qui tam suits related to off-label promotion are dismissed in the early stages of litigation, especially when the federal government does not intervene or join in the suit.174 For exam- ple, many qui tam relators have trouble surviving motions to dismiss be- cause they do not plead their fraud claim with particularity.175	cache/ihlr-2018.pdf	txt/ihlr-2018.txt
