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December 28, 2006

Article on the FDA in Scientist magazine

by @ 2:33 pm.  Filed under FDA

I found this article on the FDA from the magazine “The Scientist” interesting and wanted to alert readers to it.

The Scientist : THE FUTURE OF THE FDA

It’s short but covers the main topics of interest and what the future might hold. Hope you enjoy it.

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    FDA Contract Secured With Family Ties

    by @ 2:19 pm.  Filed under FDA

    I hesitated to post about this but then decided I’d leave it to the readers to decide for themselves. This article in the LA Times concerning the FDA and a contract secured via a family connection.

    Family tie helps win FDA contract - Los Angeles Times

    Normally, I would think much about this but since both people involved were familiar with government contracting , it does appear that they should have known better. Here is the bachground from the article

    WASHINGTON — The concerns at the office surfaced not long after their Las Vegas wedding.

    Margaret “Margo” Burnette wasn’t pleased with the contractor handling an important data project at the Food and Drug Administration, where she held a senior position. For advice, she turned in summer 2004 to her new husband, Mark A. Boster.

    Both had spent most of their careers dealing with government contracts. And Boster, she recalled, had been “ranting about this fabulous company.”

    “I did ask Mark, ‘What was the name of that company?’ And I gave the name to my deputy.”

    The sequence of events worked out well for Platinum Solutions Inc., of Reston, Va., for whom Boster was a paid advisor.

    The FDA dismissed the first contractor and awarded the job to Platinum Solutions. By this fall, the small technology company had collected about $4 million from the project. Last month it won a new, related FDA contract, possibly worth millions more.

    This seems like a clear conflict to me and is something that the FDA has come under scrutiny for in the past. Regardless of the final outcome (the FDA looked at it and no violation was found), even the appearance of conflict of interest should be avoided. The article paints a negative picture in my opinion especially since both were well aware of the rules but continue to say they had no regrets and no qualms about the situation. This sort of attitude is what bothers me. At the least, they should have said they wished they had handled it differently and been more upfront.

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