TorteDeForm

Justinian Lane

Yet another reason to oppose preemption

Regular readers of TortDeform know that we staunchly oppose preemption because we believe it is bad public policy.  Those who support preemption argue that it’s good public policy because it ensures that expert scientists are making safety decisions.  But now a group of FDA scientists have accused the FDA of forcing those expert scientists to change their opinions:

WASHINGTON — Top federal health officials engaged in “serious misconduct” by ignoring concerns of scientists at the Food and Drug Administration and approving for sale unsafe or ineffective medical devices, the scientists have written in a letter to Congress.

The House Committee on Energy and Commerce will investigate the accusations, first aired when eight agency scientists wrote a private letter in May to the F.D.A. commissioner, Andrew C. von Eschenbach.

“These allegations are deeply concerning,” said the committee chairman, Representative John D. Dingell, Democrat of Michigan, “and we intend to uncover whether any F.D.A. activity has compromised the health and safety of American consumers.”

....

The letter says that the scientists have documentary evidence that senior agency managers “corrupted the scientific review of medical devices” by ordering experts to change their opinions and conclusions in violation of the law.

Source: F.D.A. Scientists Accuse Agency Officials of Misconduct - NYTimes.com

I was lucky enough to have met John Dingell several years ago, and the man impressed me with his depth of knowledge and concern for the welfare of average citizens.  I’m glad he’s looking into the matter, and I sincerely hope this practice (if it occurred) ends.

Justinian Lane: Author Bio | Other Posts
Posted at 10:48 AM, Nov 20, 2008 in Preemption
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Comments

i hope this practice is stopped as well. unfortunately, it's not inconceivable that this really happened.

interesting how tort "reformers" also argue that preemption stifles important advances in drugs. so does improper regulation of the drug industry, though, if scientists aren't given the independence they need to determine just how effective or "advanced" these drugs are. and if they're not given the deference they're owed w/ respect to their findings, then are just pawns in the big pharma game too.

Posted by: Kia | November 21, 2008 2:00 PM

I think we are going to learn more and more about what the rank and file at the FDA believe about preemption in about 60 days.

Posted by: Ron Miller | November 21, 2008 9:19 PM