Thursday, February 2, 2012

Sen Grassley Tells FDA Commish: "Whistleblowers Are Often Treated Like Skunks At A Picnic"

Following the dustup and Lawsuit (here) filed by employees of FDA:

Which begins; (emphasis ours)

Dear Commissioner Hamburg:

I write to express my concerns over your agency's treatment of whistleblowers as a result of their disclosures to Congress, and specifically disclosures to my office. Whistleblowers point out fraud, waste and abuse when no one else will, and while they do so while risking their professional careers, they are often treated like skunks at a picnic. Whistleblowers have played a critical role in exposing harmful government actions and retaliation against whistleblowers should never be tolerated. Thus, I am particularly concerned about the treatment of whistleblower P.J. Hardy by the Food and Drug Administration (FDA).

P.J. Hardy is one of 9 FDA physicians and scientists that wrote a letter to the Presidential Transition Team in 2009 advising that, "Managers at CDRH have ignored the law and ordered physicians and scientists to assess medical devices employing unsound evaluation methods " and "ordered, intimidated, and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules, and regulations. A week after that letter was sent I wrote to FDA expressing my concern over such troubling allegations, especially in light of the fact that more than 6 years ago I wrote to the Agency regarding similar allegations at FDA's Center for Drug Evaluation and Research."

There's more. 5 pages worth.

Thanks and a hat tip to Ed at Pharmalot.

And Thank You Sen. Grassley

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