Time to reform FDA? Institute of Medicine (IOM) report challenges FDA safety regulation
Tony Spiegel
Sep. 22, 2006

Under funding, lack of data and feedback after the approval process, organizational politics are all causing FDA's safety regulation process to under perform.

Institute of Medicine (IOM) report says it is time look at Institute of Medicine (IOM) report challenges FDA safety regulation.

Timing of the report is interesting though - just before a very critical election when Republicans are trying to keep the majority in Senate and the House.

FDA needs a total organizational reengineering. Funding to monitor drugs after the approval process are critical. The feedback process is not adequate. Preemption capabilities are critical. What happened in case of Vioxx should not happen ever.

The biggest challenge though is somewhere else. The major pharmaceutical companies are so cash rich they can lobby anything in Washington. How do you keep FDA from their stealth but powerful influence?

Time to reform FDA? Institute of Medicine (IOM) report challenges FDA safety regulation
Tony Spiegel
Underfunding, lack of data and feedback after the approval process, organizational politics are all causing FDA's safety regulation process underperform.
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