The FDA did introduce its Critical Path initiative in 2004. But, even these expedited processes have become bogged down. The FDA has responded to the political winds and become cautious after the negative publicity it received from the withdrawals of drugs like Rezulin and Vioxx. The best and most recent delay in the prostate cancer world has been Provenge.

Once a drug passes Phase I clinical trials — which test for high toxicity — and Phase II which defines dosing- why not make it available for general distribution through the NCCN, which has superior access to specialized medical expertise than the FDA. The blunt fact is that no matter how able FDA scientists and physicians are, none of them have the years of experience dealing with particular tumors and particular drugs that specialist, scientists and physicians can bring to this project.

Joel T Nowak MA, MSW