TortsProf Blog

Editor: Christopher J. Robinette
Widener Commonwealth Law School

Monday, September 25, 2006


The FDA's acting commissioner Andrew von Eschenbach issued on Friday a response to the Institute of Medicine report on drug safety.  It's a bit of a dancing act, avoiding endorsing the harshest criticisms while still trying to indicate a willingness to change:

As the IOM report recognizes, much progress and reform of FDA's safety oversight enterprise is already underway. Specifically, the FDA has led an aggressive effort, which includes developing new tools for communicating information to patients and new resources for drug safety, to improve the management of the process for how we uncover and communicate important drug safety issues. All drugs have risks. Our challenge is to uncover these risks as soon as possible. Through initiatives like Critical Path and Personalized Medicine, we are also working to improve the tools we use, to more effectively evaluate new products and processes.

I am committed to taking additional steps and will look to the initiatives recommended by the Institute of Medicine, to ensure we continue to fulfill our mission. Over the next months you will be hearing extensively from us about these new endeavors, including a number of initiatives aimed at improving the opportunities for employees of FDA to shape a more effective work environment.

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One has to wonder if the proposed FDA regulations are going to do more harm than good. The fact that the FDA is "dancing" around the issue either means that they realize this themselves, or that they simply don't want to acknowledge that anything is wrong with the way that they do things. Check out what THIS GUY had to say. He makes some pretty good arguments against the new regs.

Posted by: Derrick | Sep 26, 2006 8:09:30 AM

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