By Ed Silverman January 26, 2011

http://www.pharmalot.com/2011/01/the-fda-and-its-pilot-pharma-fraud-program/

Earlier this week, the US Department of Health & Human Services trumpeted its efforts to root out healthcare fraud and recover $4 billion for taxpayers, including about $2.5 billion attributed to violations of the False Claims Act, something that has ensnared many drug-makers. But the agency has also initiated a little-known pilot program that it hopes will deliver still more returns.

Called the FDA Pharmaceutical Fraud Pilot Program, or PFPP, the initiative was begun in fiscal year 2010 with $1.7 million* in HHS funding and was “designed to detect, prosecute, and prevent pharmaceutical, biologic, and medical device fraud.” The focus is on fraudulent marketing schemes, application fraud, clinical trial fraud, and flagrant manufacturing-related violations. Covers a lot of ground, yes?

In its report, the HHS says the program, which was first reported by Drug Industry Daily, will pursue “all available criminal and civil remedies to punish and deter” fraud. And the effort is being coordinated with various US Attorneys (see page 69 for details). Still more interesting, these are the leads the HHS claims to have begun investigating:

Two off-label promotion matters involving different brand-name drug-makers; yet another brand-name drug-maker for various violations of promotional issues including overstating efficacy, omitting material facts and promoting unapproved uses; two matters involving fraud associated with current Good Manufacturing Practice issues; an instance of clinical trial fraud documents are alleged to have been falsified by a study coordinator, a contract research organization that reportedly falsified study documents related to studies conducted for drug-makers; and a contract testing lab that allegedly falsified data used to support multiple drug applications to the FDA.

And these are only the investigations that HHS chose to list. How these will pan out remains to be seen, of course, but the rundown suggests that several companies should start reviewing their operations and lawyer up. The big question, though, is whether any execs will do the perp walk.