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Dysfunctional FDA Computer System Delays Drug Safety Reporting By Four Years

An independent report by the Breckenridge Institute has revealed a "dysfunctional" and new computer system the FDA has been using to track post-market drug safety since 2005 -- the Adverse Event Reporting System (AERS) -- won't be fully operational until 2009 at the earliest. Partly because it's taxed by the number of drug safety reports (more than 400,000 annually, and rising) the current AERS erases close to an hour of a safety expert's valuable time every day.

The real problem, according to the report: A culture of incompetence behind the scenes at the FDA, and, in particular, bureaucratic infighting leading to duplicative work on the system by its Office of Information Technology. Even worse, using off-the-shelf software in 2004 to craft a drug safety system would have allowed the AERS to be running smoothly by 2005 for about a fifth of the cost the agency has already spent on a faulty system, a cool $25 million.

Instead, IT staffers preferred a customized approach that could track all problems related to all FDA-regulated products, despite grave concerns by drug safety officials who felt the agency couldn't wait for additional analysis from contractors to build a system from scratch.

After the report was completed, no surprise, the FDA requested the Breckenridge Institute delete most of it, which they refused to do. And a deputy director at the agency's drug center defended the delays, citing the complexity of such a system along with the need to get it right.

There's no doubt at all the FDA needs to get it right, but as we've discovered, even a bare minimum of drug safety is a tall order especially for this agency, no matter which agency or contractor is doing the investigating.

You have no reason to wait for a computer system to cure all the problems inherent in this agency that gives a free pass to this drug-addicted paradigm that passes for conventional medicine, especially when far better and safer solutions exist that are just as effective.

Wall Street Journal March 3, 2007 Registration Required

Reuters March 5, 2007