Brent Saunders and Anthony Farino are partners in, and Pharmaceutical Industry Compliance and Risk Management Practice at PricewaterhouseCoopers LLP.
April 1, 2005 By:
John T. Bentivoglio
Every quarter, pharmaceutical manufacturers confront a dizzying array of price reporting obligations. Participation in the Medicare, Medicaid, Veterans Administration (VA), and Public Health Service (PHS) programs requires manufacturers to collect, organize, distill and manipulate vast quantities of information, and to generate from that data reportable figures that can have an enormous impact on the company's bottom line. It is critical that these figures be correct, not only to help ensure the integrity of these public programs, but because submission of false data to a federal agency is a prosecutable criminal offense, and the civil penalties and exposure can be staggering.
The pharmaceutical industry stands in the crosshairs of federal and state law enforcement agencies. It is not being targeted by FDA for regulatory violations, as one would expect, but by many other government agencies