FDA Told U.S. Drug System Is Broken
Expert Panel Calls For Major Changes

By Shankar Vedantam
Washington Post Staff Writer
Saturday, September 23, 2006; Page A01

The federal system for approving and regulating drugs is in serious disrepair, and a host of dramatic changes are needed to fix the problem, a blue-ribbon panel of government advisers concluded yesterday in a long-awaited report.

The analysis by the Institute of Medicine shined an unsparing spotlight on the erosion of public confidence in the Food and Drug Administration, an agency that holds sway over a quarter of the U.S. economy. The report, requested by the FDA itself, found that Congress, agency officials and the pharmaceutical industry share responsibility for the problems -- and bear the burden for implementing solutions.

The report represents a watershed moment after two years of controversy over the safety of such widely used drugs as pain relievers and antidepressants. The Institute of Medicine is part of the National Academies, chartered by Congress to advise the government on scientific and health policy issues. Its recommendations traditionally carry great weight.


.... for full story: http://lib.store.yahoo.net/lib/reali...NFDAbroken.mht

Wannabe,

Wasn't this the same agency that encouraged and then helped Biogen fast track Tysabri the first time around

Harry

And the last time I read about the FDA at least half of its people had big money associations w/pharma companies.

Hence the fast-tracking.

If it smells bad it probably is bad.

What can I say... .. Most Government Agencies don't work the way they are supposed to work.

Too many Chiefs and not enough Indians.

Yessir. Its also the same agency that believed Biogen when Biogen said the faulty Lots of Avonex would not hurt anyone and thus did not need to contact the patients.

Just read that a very recent former head of the FDA is in big trouble for not declaring conflict of interest stock ownership that recently netted/grossed? him 100k+ while in that job.
Tsk, tsk.

I appreciate his statement of being unable to understand the difficult government forms.

But, OY- this is a person who can afford a lawyer!

Is anyone surprised? Honestly!

That's just how the world of power works.

I gave up a long time ago thinking that grownups were all like Ward Cleaver