Fools rush in
. Having worked in the publishing industry most of my adult life, I know all about deadlines. But I'd venture to say that most people, not just the editors of the world, are familiar with the concept in one form or another. Deadlines, in all their shapes and varieties, are a basic part of business, and, therefore, a basic part of daily life for just about everyone. So forgive me for not being more sympathetic to the "plight" of the FDA, which is using them as an excuse to explain why so many of the drugs they've approved in the past few years have turned out to be ticking time bombs that have exploded in the faces of the American public. Harvard researchers recently examined approval records spanning several decades and found that the drugs approved by the FDA at the last minute prior to deadline are four to five times as likely to cause safety problems as drugs approved with time to spare. Cases in point: Vioxx, Bextra, Baycol, and Avandia were all approved "just in time" -- and later yanked from the market due to the serious health risks associated with them. It's yet another frightening commentary on the agency's competence -- or complete lack thereof. Until 1992, the FDA didn't even operate under a deadline system. But that year, a new law went into effect that allowed the agency to charge massive approval fees to any manufacturer wanting to put their product on the market and actually be able to tell the public what it's good for. In return, the FDA agreed to make a decision about any substance submitted for approval within 12 months. In 1997, Congress tightened that deadline to 10 months. And, according to one of the authors of the study mentioned above "'FDA staffers by their own admission feel very much under the gun as these deadlines loom.'" So here's my question to those "poor" FDA staffers so stressed out about their upcoming deadlines: If after 10 months of careful examination of the studies on any submitted drug, you're not totally convinced that it's safe enough to put on the market, why risk it -- and by "it" I mean the health and safety of millions of people? As the FDA's own drug chief says "We have the option of denying approval altogether if there is any question about safety." Unfortunately, that doesn't seem to be an option that the FDA explores regularly enough. The sad and scary truth is, the agency that's supposed to be watching out for our safety is more concerned with justifying its ridiculously inflated paychecks and keeping the companies writing them happy than it is with doing its job. And there's no deadline extension on earth that can fix that. Source: "FDA deadlines may impact drug safety," The Washington Post (www.washingtonpost.com), 3/26/08 | 
