IOM Head Says Stronger FDA is Needed

By Dickinson, James G

INSTITUTE OF Medicine president Harvey Fmeberg said in March that the future of personalized medicine requires “a stronger Food and Drug Administration, not a weaker Food and Drug Administration, to enhance the speed and effectiveness of personalized medicine. We need to put enough resources in the agency so that it can do its increasingly challenging and difficult assignment.” He made this assessment at a meeting of the Personalized Medicine Coalition. The coalition is a group of agencies, pharma and diagnostic companies, research institutions, venture capitol groups and others focusing on genetic testing and other aspects of the up-and-coming personalized medicine arena.

Without such strengthening measures, Fineberg said, the agency may never reach the point where it can deal adequately, for example, with combinations of diagnostic and therapeutic innovations which can be part of personalized medicine.

Fineberg: agency needs more

Several health leaders recently have portrayed the genomic revolution as coming to the point, just in the last year or so, that it calls for more focus on next steps to push it into healthcare, specifically the drug pipeline and FDA.

In January 2007 just a few links had been found between disease conditions and genes using genome-wide association studies. By December there were dozens, due to technology breakthroughs and the haplotype map (published in 2005), which has cut the cost of a study from $10 million to under $1 million.

Fineberg said genomics by itself will not solve our health costs crisis or the slowdown in the drug pipeline or the inequities that have helped push the US out of the top tier of nations in health statistics. But he said, “I do think that it is very important for everyone concerned with personalized medicine to focus on removing the obstacles to its wider deployment and use. And that means a strategy for research that encourages the private sector and the public sector to collaborate on the entire spectrum from basic through translation and applied research in a way that our country has yet to fully achieve.”

-James G. Dickinson

Copyright Haymarket Media, Inc. May 2008

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