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www.fdanews.com/articles/130774-as-off-label-marketing-cases-increase-drugmakers-see-more-criminal-charges

As Off-Label Marketing Cases Increase, Drugmakers See More Criminal Charges

October 4, 2010
With the FDA and other agencies stepping up enforcement of off-label marketing, the fines levied against drugmakers are now totaling billions of dollars. But a lesser-noticed component of the enforcement strategy –– an increase in criminal charges associated with settlements –– may have the biggest impact on putting a stop to the practice. The increase in criminal charges has not necessarily been due to companies committing more violations, but is instead part of a concerted effort by the FDA, the Justice Department and other federal agencies to hold individuals accountable rather than simply levying fines on the companies.
Drug Industry Daily