NYT ON "SHODDY" FDA APPROVALS

Editorial on Device case

Today's NYT carries an editorial on the device case discussed last week on Pharmalittle--the intervention by four Dem congressmen on behalf of a device, its getting fast-track appoval without appopriate review of either safety or efficacy (both of which had gotten thumbs-down by earlier FDA reviewers), and the pols receiving large campaign contributions from the manufacturer soon after. FDA will now do the review it should have done in the first place.

The editorial is here

http://www.nytimes.com/2009/10/03/opinion/03sat3.html?_r=1&emc=tnt&tntemail0=y

The NYT calls it "shoddy." A little understated in my view. A knee device, like this one, seems unlikely to cause avoidable death. But serious injury, which could lead, in turn, to death, does not seem out of the picture. So this is potentially negligent homicide on the part of the pols and FDA Commish Von Esch who was there at the time, and involved in the bogus approval.

If there are any FDA'ers out there, current or former, I wonder if they could estimate how often such approvals occur?

Should the facts so indicate, all in this case should be prosecuted. And not for "shoddiness."