ISPE member Paul Seligman, M.D., M.P.H., is one of two U.S. FDA members on the steering committee for the Centers for Education and Research on Therapeutics (CERTs). Dr. Seligman is the director of FDA's Center for Drug Evaluation and Research (CDER)'s Office of Pharmacoepidemiology and Statistical Sciences (OPaSS). The other current FDA representative on the steering committee is Susan Gardner, Ph.D., from the FDA's Center for Devices and Radiological Health (CDRH).

CERTs, administered by the U.S. Agency for Healthcare Research and Quality in consultation with FDA and other HHS agencies, is composed of seven academic centers. The research agenda is led by the national steering committee that includes representative leaders in health care, public health, government and industry.

"CERTs continues to have broad representation on the steering committee from FDA, as CDER, CBER and CDRH have been represented," Dr. Seligman said.

The steering committee works to shape and support the CERTs mission to conduct research and provide education in order to advance the optimal use of drugs, medical devices and biological products.

Over the past two years CERTs has sponsored a series of multi-disciplinary workshops, called the Risk Series, focusing on risk communication, risk management, benefit assessment and working with the media. Each workshop included 45 to 50 invitees representing government agencies, medical and professional societies, universities, pharmaceutical companies and consumers.

"The idea was to talk about key issues and to identify gaps or areas where further research is needed. A number of publications, some still in press, have been generated by this series and recommendations from the series can serve as a guide as to where research resources should go," Dr. Seligman said.

At a recent quarterly CERTs steering committee meeting, the discussion was focused on a series of strategic initiatives planned by the organization, Dr. Seligman said.

Among the top CERTs strategic initiatives that were identified during the meeting were:

• Following up on the Risk Series recommendations.
• Examining the impact of the Medicare Modernization Act and its implications on the availability of medications and possible risks and benefits of the new law.
• Continuing to focus on improving the safety of marketed therapeutics, including consideration for developing a national problem list of therapeutics.
• Improving the on-going educational progress and curriculum development for health care providers and recognizing that doctors and pharmacists play a critical role in the risk-benefit equation.
• Evaluating the impact of computerized physician order entry systems, where rather than writing a prescription, the doctor just enters it right into a computer.

"All the initiatives fit very nicely into FDA's strategic initiatives and are supportive of what we're trying to do at an Agency level," Dr. Seligman said. "With computerized physician order entry systems being increasingly used in hospitals and in-patient settings, it is vital to understand how well they are being accepted and used, and whether we are realizing their potential to reduce medical errors. As we continue to strive to improve the quality of health care by improving the safe use of all medical products, I expect that the CERTs will play an increasing role in defining best practices and assessing the impact of risk management efforts, regulatory guidance and legislation on quality."

(This article has been modified from FDA CDER's publication News Along the Pike, July 2004 – Ed.)

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