Friday, March 05, 2010

Pharma Execs - Book 'em Danno!


The FDA plans to increase prosecutions of pharmaceutical and food industry executives as part of an effort to refocus its criminal division, which has been under attack in Congress and is criticized in a new government report, the WSJ said this morning.

In a letter to Sen. Chuck Grassley, the FDA says an internal committee has recommended that the FDA and its Office of Criminal Investigations “increase the appropriate use of misdemeanor prosecutions, which allows responsible corporate officials to be held accountable and is a valuable enforcement tool.”

A report set to be released today by the Government Accountability Office, Congress’s watchdog arm, says the Office of Criminal Investigations has operated autonomously for years with little or no accountability to top FDA officials. It said the investigations office’s whose budget rose 73% between 1999 and 2008 to $41 million, has fallen short compared with other agencies in developing performance standards.

The FDA officials largely agreed with the assessment and in the letter to Grassley, it said the agency is “developing meaningful performance measures” for the criminal office as part of an initiative begun in August. The FDA said it wants the criminal office to share information with FDA leaders regularly, and to do a better job picking cases.

You can see the GAO report here and other GAO info here.

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