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FDA Plans Get Tough Attitude With Pharma, Food

Posted by Jane Akre
Thursday, March 04, 2010 1:38 PM EST
Category: Protecting Your Family
Tags: FDA, Investigations, Grassley, Pharmaceutical Industry, Food Safety, GAO, Guidant, Defibrillators

FDA plans to get tough on big pharma and food executives who sell bogus products.



In China, the men that put melamine-tainted milk into the marketplace, killing six children, were convicted and faced the maximum penalty of death.

While corporate wrongdoing in the US usually results in a fine, a recall, or a slap on the wrist, the FDA plans to get tough on white collar crime after a critical report on its performance.

In a letter to the Senate Finance committee, signed by FDA head Dr. Margaret Hamburg on March 4, the agency plans to increase misdemeanor prosecutions of executives in the pharmaceutical and food industry after a lax performance in that area.

It is the Office of Criminal Investigations which oversees counterfeit drugs, corporate officials, and misconduct by FDA employees.

The letter comes on the heels of a new government report by the General Accountability Office which finds that six OCI field offices are not doing their job investigating on a timely basis and have operated with little accountability.

OCI has $41 million in funding and 230-person staff and that led to approximately 400 convictions in 2008.

From its inception in 1992 until the end of fiscal year 209, OCI reports it obtained 4,392 convictions resulting in $9.89 billion in fines and restitution. But the GAO finds it has fallen short compared to other agencies in misdemeanor prosecutions.

The GAO review was requested by Sen. Charles Grassley of the US Senate Finance Committee.

The FDA says in a letter to Sen. Grassley (R., Iowa), that it plans to "increase the appropriate use of misdemeanor prosecutions, which allows responsible corporate officials to be held accountable and is a valuable enforcement tool."

The OCI does not want to be considered overly aggressive, the WSJ reports. On the front burner - improper marketing of narcotic drugs, and drug counterfeiting.

OCI Investigation- Guidant

Most recently, the medical device manufacturer Guidant LLC, was charged with violating FDA rules about reporting safety problems with some of its implantable defibrillators.

Boston Scientific, which owns Guidant, previously announced it would pay $269 million in connection with the charges.

Guidant was charged with concealing information from the FDA regarding the catastrophic short-circuiting failures of three models of its implantable cadioverter defibrillators, the Ventak Prizm, and the Contak Renewal. #

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