Pharmaceutical giant GlaxoSmithKline reached a record $3 billion False Claims Act settlement with the U.S. Justice Department this month—the largest healthcare fraud payout in U.S. history. But it’s not just the settlement amount that has drug companies shuddering.
The settlement agreement also includes a series of rigorous compliance directives that serve as a model for compliance with restrictions on off-label promotion of pharmaceuticals. The corporate integrity agreement details the government’s expectations on compliance programs for drug company compliance with the FCA.
