FDA on IOM

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.