UNPROVEN DRUGS ARE RECEIVING FDA APPROVAL?

ARE TOO MANY UNPROVEN DRUGS RECEIVING FDA EARLY
APPROVAL? PROCESS COMES UNDER SCRUTINY

With the Food and Drug Administration's handling of
drug safety already under a microscope, the
suspension of multiple-sclerosis drug Tysabri creates
a new area for scrutiny: the agency's process for
rushing out promising new treatments for the most
serious conditions. Biogen Idec Inc. and Elan Corp.
yesterday announced that they would suspend Tysabri
from the market and from clinical trials after
confirming that one patient had died of a
neurological condition called progressive multifocal leukoencephalopathy, or PML. What sets the Tysabri
case apart from other recent drug-safety
controversies is that it was allowed on the market
through the FDA's "accelerated approval" program.
Under that mechanism, a drug that treats a life-
threatening disease and represents a significant
improvement over available therapies can win approval
with less data than typically required, though the
company is supposed to do a follow-up study.

Anna Wilde Mathews And John Hechinger,
The Wall Street Journal, 03/01/2005
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