About a year ago in this space, I asked rhetorically, Is the FDA Growing a Spine?, believing they were completely clueless about, among other things, drug safety. There may be signs, however, the FDA has quietly toughened up a bit...
It's hard to tell whether some of this "caution" is the real thingor a lack of manpower at the federal level, as it's become quite commonfor the agency to postpone any decisions for three months. No matterwhich one is at work, the economic numbers via Nasdaq's BiotechnologyIndex indicate a 14 percent decline, meaning the mega-drug companies may be on a diet unwillingly.
Another reason those spines may be straightening: Chatter among somethat some FDA regulators who approve drugs later found to be toxic andunsafe may have to account for their actions in front of aCongressional panel.
A more upright position at the FDA, however, won't protect you andyour family from existing concerns -- approving an antibiotic that harms your liver or spraying your meat with viruses.
New York Times September 29, 2006 Registration Required
The (Lakeland, Fla.) Ledger September 29, 2006