The FDA And Its Pilot Pharma Fraud Program
5 CommentsBy Ed Silverman // January 26th, 2011 // 11:46 am
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 drugmakers. 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 drugmakers; yet another brand-name drugmaker 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 drugmakers; 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.
ex-FDA
Until the justice department honestly looks into and prosecutes fraud and racketeering by FDA officials this is a joke.
Director of Pharmacy
the Dean and senior leadership at our academic medical center just banned all employees from speaking for pharma for fear of bias. interesting that the Dean and his minions serve on the boards of PBMs and companies that do business with the university hospital system.
the hypocrisy continues and the academics who don’t treat patients and the FDA officials themselves are dirty.
Merck Man
They won’t have to look too far or too hard to find lots of fraud. It’s rampant throughout the industry.
Aldara1
I have researched the 3M-pharma drug Aldara/imiquimod for over 10-years starting with its very conception and following its development through to its ultimate approval in Feb 1997 and to date, there is no better model of corruption and fraud on the FDA than the way this drug reached the market. Unlike most, the manufacturer of Aldara spread literature deep and wide throughout world wide data banks and the general public domain prior to the “great purge” that took place in the middle of the last decade.
Pharmaceutical Fraud
The initiative to introduce pilot program to avoid pharma frauds but it will be much effective if more people are united to take strict actions against frauds working in most areas.