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 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 thing or a lack of manpower at the federal level, as it's become quite common for the agency to postpone any decisions for three months. No matter which one is at work, the economic numbers via Nasdaq's Biotechnology Index 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 some that some FDA regulators who approve drugs later found to be toxic and unsafe may have to account for their actions in front of a Congressional panel.
A more upright position at the FDA, however, won't protect you and your 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
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