BIG PHARMA at work
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Psychiatric drugs promote mental illness and early daath--Prof. Gotzsche
Shortages in Essential Drugs--Big PhARMA at work
MOST drugs are from China and India
Medical Device Makers cannot be sued, Supreme Court Rules
Ghost writing the norm for over a decade
journal articles are advertising dressed as science--examples
Top 10 Drug Recalls and Warnings of 07
FDA Fraud Program
Big PhARMA ghost writes journal articles
Big PHARMA pays generic manufacturers to not ...
New CANCER drugs add little to life expectancy--why
Big Pharma influences the DSM manual
Most Drugs Now are both Imported and not Tested for Purity
Slash taxes or we move our facilities
RU-486 comes from China, now--more tainted drugs
Antidepressants Proven useless for most
Heart Medication kills 22,000 in 2 years
Statin combination Vytorin doesn't work, etc.
Off Label Drug Pushers
0ff Prescription Market Law Eli Lilly violates for Zyprexa
Price Gouging for Orphan Drugs
Marketing department ran massive drug trial for VIOXX
Direct to consumer spending on the rise
Pharma Lobby and Democrats
U.S. Pharma Moves to China and India
Research and Production moves to China and India
Cancer Generic Drug Shortage increases sales of patented drugs
FDA Fraud Program

The amount budgeted ($1,700,000) for investigation indicates that the FDA plans to do little.  Furthermore, the principle targets are not at the core of wrong doing.  Off label marketing by Big PhARMA is just a minor issue, however, it is one which makes a mockery of the need to get a drug patented.  For some block buster drugs the off-label sales equals that of the FDA approved usage. The amount recovered is insufficient to discourage off-label marketing.  The second area of FDA investigation is the fraud from the overcharging of Medicare for prescription drugs.  Government is in bed with the corporate pigs;  how can the FDA which is pro-PhARMA investigate its support group?  

The FDA and it Pilot Pharma Fraud Program.

By Ed Silverman January 26, 2011

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.


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