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How to Fix FDA

This article was originally published in RPM Report

Executive Summary

FDA's problems are too many to count. Drug safety expert and prominent cardiologist Steve Nissen, MD, says sweeping reforms are the only answer.

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McClellan's FDA Team

When Mark McClellan became FDA commissioner in late 2002, he brought with him a cadre of like-minded managers and policy advisors. Many were economists; all were advocates for private-sector innovation. Most have departed from FDA. Their departures may have some short-term political benefits for the agency; but they leave a legacy of economic interest in the way FDA works and affects society.

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