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New FDA commissioner sees challenges, opportunities

January, 2003 -- Commissioner of Food and Drugs Mark B. McClellan, M.D., Ph.D., says passage of the medical device user fee act, the bioterrorism bill, and the reauthorization of prescription drug user fees by the 107th Congress "represent the most substantial expansion of the agency in more than a generation."

"We'll have the opportunity and resources to achieve new levels of improvement in getting safe and effective treatments to market," McClellan said upon assuming his new responsibilities.

McClellan was sworn in by Vice President Dick Cheney as the new FDA Commissioner on Nov. 14, 2002. He had served as a member of the White House Council of Economic Advisers since July 2001. McClellan was also a senior policy director for health care and related economic issues at the White House.

Prior to joining the Bush Administration, McClellan was an associate professor of both economics and medicine at Stanford University, a practicing internist, director of the Program on Health Outcomes Research at Stanford, and a research associate of the National Bureau of Economic Research. He was a member of the National Cancer Policy Board of the National Academy of Sciences, associate editor of the Journal of Health Economics, and co-principal investigator of the Health and Retirement Study, a lengthy study of the health and economic well-being of older Americans.

From 1998-99, he served as Deputy Assistant Secretary of the Treasury for Economic Policy, where he supervised economic analysis and policy development on a wide range of domestic policy issues. McClellan holds a degree in medicine from Harvard Medical School and a Ph.D. in economics from the Massachusetts Institute of Technology.

The new Commissioner's first public appearance was at a groundbreaking for a Center for Drug Evaluation and Research office building at the FDA's new White Oak campus, where much of the agency eventually will be consolidated. McClellan spoke of his own focus for the FDA's future.

In its primary mission of protecting and promoting the public health, McClellan said that the importance and complexity of the FDA's work will only increase in the years to come. This means that while more medical products will be available to save and improve lives, the FDA also must think critically and carefully about how it uses its resources to improve the public health.

"We are not here just to check boxes on an inspection list, just because that's the way we've been doing it for the past 20 years," McClellan told those at the groundbreaking. "We are here to implement the best possible approaches to reduce risks to the public health, using the budget and authority that Congress has given us. This challenge requires expert knowledge, creative thinking, and dedicated effort, day in and day out."

McClellan also spoke of the threat of terrorism. The FDA plans to help make the country more secure through research and through a greater understanding of the human genome and the way proteins and other chemicals work in the body. Progress in information technology and other fields also will contribute, McClellan says.

Other challenges for the FDA include helping medical professionals and patients reduce preventable adverse events by making greater use of modern medical information systems to identify the causes, and by ensuring effective communication with health professionals and consumers. McClellan says that these changes may require new thinking at the FDA, in terms of how the agency designs its regulations and programs with the future in mind.

McClellan noted that President Bush and Secretary of Health and Human Services Tommy G. Thompson have highlighted and supported the agency's work to:

  • Improve and protect public health through smart regulation, using the best science and techniques of risk management
  • Quickly respond to the new challenges of bioterrorism and food security
  • Improve access to affordable new medical treatments that can improve health
  • Improve the safety of medical care and prevent medical errors
  • Help consumers get truthful and accurate information about the products they use, because consumer choices are even more important than medical technology in preventing disease and improving health.

Source: FDA News Digest

Posted: January 2003