The FDA and it Pilot Pharma Fraud Program.
By Ed Silverman January
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
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
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.