FDA Releases "Critical Path" Report on Medical Product Development at AAAS, During Research!America Meeting

Mark McClellan, Commissioner of the U.S. Food and Drug Administration (FDA), released a new white paper on 16 March at AAAS as part of the Research!America meeting.

"The future may be brighter when it comes to our health," he said. "New science can result in a more individual and preventive kind of medicine at lower cost."

According to the FDA, the paper, "Innovation Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products," is intended to focus attention on the need for superior development science in order to better address the "pipeline problem" in medical product development. Specifically, it discusses the importance of updating and better utilizing the applied sciences in order to ensure a more efficient and predictable development process, and makes clear that such movement along the "critical path" is a crucial aspect of the FDA’s 21st century mission of both protecting and advancing the public health.

"Despite current efforts, breakthroughs in labs are not reaching patients in a reliable, affordable manner," McClellan said. "This initiative brings together the best scientists, in a type of partnership between the F.D.A. and scientific institutions, to bring safe, effective and reliable treatments to patients as quickly as possible."

Last Spring, McClellan and Lester Crawford directed FDA staff to investigate the downward trend in applications for drugs, biologics and medical devices and charged them to identify opportunities that could help avoid the chokepoints and correct the problem, the FDA noted. The new white paper points out the many hurdles products are encountering on the "critical path" to commercialization. The paper identifies potential research opportunities that could improve the medical product development and evaluation process by making the process more predictable and less costly.

Dr. Alan Leshner, CEO of AAAS, participated as a respondent in the open question and answer portion of the Research!America annual meeting and national forum.

Research!America is a not-for-profit organization that represents more than 40 million Americans striving to make medical and health research a higher national priority. Its advocacy-related materials and programs, focuses on educating policymakers about the critical need to increase the nation's investment in medical and health research.

For more information, please visit http://www.researchamerica.org.

To access the FDA White Paper, please click here.

16 March 2004

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