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.
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.