Why would the FDA choose this cruel and insupportable option when so many better options were (and still are) available to them? Former FDA Commissioner Alexander Schmidt may have foretold the answer in his 1974 testimony:
“In all of FDA’s history, I am unable to find a single instance where a Congressional committee investigated the failure of FDA to approve a new drug.”
This must now be that instance. Congress must investigate this failure of the FDA to approve Provenge. Given the FDA’s history of subsequently approving every drug that the Abigail Alliance has championed, it might well be that the FDA should also consider Sam Kazman’s words from “Deadly Overcaution: FDA’s Drug Approval Process.” Kazman ponders the unasked question that hangs over every announcement that a drug previously delayed by the FDA has now been approved:
“The question is this: If a drug that has just been approved by FDA will start saving lives tomorrow, then how many people died yesterday waiting for the agency to act?”
For the public good Congress must now ensure that the FDA answers these difficult questions, that the answers demonstrate that patients are being appropriately considered, and that the needs of terminal cancer patients are met by the expanded approval paths available to the FDA right now. To quote Abraham Lincoln, The dogmas of the quiet past, are inadequate to the stormy present. As our case is new, so we must think anew, and act anew.” We must do it now.
Additional Rally Video
Scott Riccio
Founding Member and Advocate
A Right To Live
patientsrights@arighttolive.com
312.420.3296
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