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The Politics of Drug Safety: An FDA Whistleblower's Push for Reform

This article was originally published in RPM Report

Executive Summary

FDA official David Graham went on Capitol Hill to discuss his view of what's wrong with the drug safety review process. He gained acclaim during the Vioxx aftermath, and proved he still has an avid following in Congress.

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FDA is missing more new drug review deadlines: at least seven in the first eight months of this year. The experiences of those delayed applications indicate some interesting ways to interpret what it means when a user fee date comes and goes without an FDA decision. One clear observation: the longer a sponsor has to wait after the user fee deadline, the worse the likely result.

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