Mark McClellan, MD, PhD, the FDA Commissioner delivered the keynote speech at the FDA/PhRMA Workshop on Risk Detection, Management and Communication: Quantitative Perspectives held in November 2003 in Bethesda, Maryland (Dr. McClellan has recently been nominated to head another federal agency — the Centers for Medicare & Medicaid Services).

Dr. McClellan stressed the need to find better ways to get more value from medical products, and said effective risk management programs are a key part of these efforts. He said no product is safe; all approved products carry certain risks. Everyone involved in product development needs to identify and manage the risks. He said "We (at FDA) are stressing the goal of efficient risk management — finding the least costly approach to achieving the maximum risk reduction for our population, including both risks of products and risks of the diseases that new medical products are intended to treat." Dr. McClellan said risk management at FDA starts with the review process for new medical products, and continues through oversight of appropriate and up-to-date labeling, and other efforts to promote the appropriate use of medical products.

Dr. McClellan emphasized the potential for pharmacogenomics to help determine how genetic differences between patients influence how they might respond to a particular medication. He said, "When people have a bad response to a particular medicine, we don't really understand why these differences happen, or which patients are most likely to realize certain benefits. Pharmacogenomics aims to shed some scientific light on this problem."

He acknowledged the need to have the technology to learn about the full profile of a drug after its approval in an efficient manner. New knowledge about benefits or risks needs to be conveyed to both patients and doctors quickly, and doctors' abilities to use medical treatments in ways that maximize benefits and minimize risks needs to be improved.

Dr. McClellan acknowledged the role of FDA's spontaneous adverse event reporting system in identifying "signals" of potential problems noting these reports rarely provide definitive evidence of causal relationship. The FDA is working to develop active surveillance systems whereby complete and reliable information can be obtained by linking directly into electronic medical records. Additionally, the agency is making information available efficiently through electronic labels and MedGuide (which is a form of FDA-required patient labeling).

Electronic prescribing, Dr. McClellan said, has the potential to eliminate many preventable adverse events. The FDA has a number of initiatives underway aimed at enabling e-prescribing. According to one estimate implementation of e-prescribing in the U.S. could prevent over 2 million adverse drug events each year, more than 130,000 of which would be life-threatening. Such prevention is estimated to save the U.S. health care system $27 billion annually.

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