Justice Department To Focus On Pharma Overseas

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bribeThe head of the Justice Department’s Criminal Division warned the pharmaceutical industry that there will be more criminal enforcement against interactions with foreign officials, according to The Legal Times.

Speaking to the 10th Annual Pharmaceutical Regulatory and Compliance Congress, assistant attorney general Lanny Breur said the application of the Foreign Corrupt Practices Act to the pharmaceutical industry will be pushed “in the months and years ahead.” Legal Times adds that he made a point of noting the extent to which there is government involvement in foreign health care systems, which he says creates a “significant risk that corrupt payments will infect the process.”

The Justice Department “will be intensely focused on rooting out foreign bribery in your industry. That will mean investigation and, if warranted, prosecution of corporations, to be sure, but also it will involve investigation and prosecution of senior executives,” Breuer told the crowd, adding that individuals will be held accountable, according to The Legal Times.

“I don’t care if you’re a physician and I don’t care if you’re the clerical worker. It has to do with what you do. But if you do it, your MD degree is not going to be a shield,” Breuer said. Overall, he said, the Justice Department is pursuing more than 120 FCPA investigations in cooperation with the FBI and the Securities and Exchange Commission.

And Tony West, an assistant attorney general and chief of the department’s Civil Division, noted that he recently told the Senate Judiciary Committee that enforcement will not be limited to companies.

Johnson & Johnson, you may recall, got caught up in one of these FCPA embroglios two years ago. You can read about that here.

Hat tip to Legal Times

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  1. Woo Hoo!

  2. This is the beginning of what it will take.

    It will be “interesting” to see what form a backlash will take. It does not seem likely that the pigs will leave the trough easily.

  3. Outstanding news!

  4. We should not underestimate the significance of the choice of controls in clinical trials. It is instructive to study how the final recommendations found in ICH E10 guidelines came to be. http://www.scribd.com/doc/22522323/CHOICE-OF-CONTROL-IN-CLINICAL-TRIALS-ISSUES-AND-IMPLICATIONS-OF-ICH-E10

  5. What about hybrid med devices (such as Listerine Whitening strips that J&J is linked to, and the like). There’s no reason they should not be scrutinized as pure med devices.

    Hailey

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