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The FDA and the Future of Medical Innovation

Friday May 2003


Hon. Mark McClellan Commissioner, Food and Drug Administration

The Food and Drug Administration (FDA), originally chartered to protect Americans from medical frauds and hucksters, has evolved into a federal agency with a $1.6 billion dollar budget responsible for products that account for 20% of the U.S. economy.

Critics of the FDA point out that its sprawling, risk-averse bureaucracy produces the most expensive and time consuming drug approval process in the world. They note that the FDA’s insistence on lengthy clinical trials needlessly delays the deployment of life-saving new drugs and medical technologies by months or years, costing American lives in the process. In an era where the opportunities to transform genomic information into medical knowledge requires a great private sector investment, the FDA’s regulatory structure can hinder medical progress.

In September of 2002, President Bush appointed Mark McClellan—a physician and an economist—as FDA Commissioner. Since then, Commissioner McClellan has encouraged the FDA to seize upon the public health opportunities and challenges of the 21st century. In recent months, he has encouraged FDA officials to look into new drug evaluation models using genetic markers and new statistical methods, and is instituting “root cause analysis” of every drug that is rejected by the FDA so that manufacturers can design better drugs and promoting ways to reduce the cost of developing new medicines and devices.