FDA Creates New Genomics Position

Kathryn Foxhall

February 06, 2009

February 6, 2009 — The US Food and Drug Administration (FDA) said this week it is creating a new position for coordinating genomics activities in its Office of Chief Scientist.

That scientific area has become a much higher focus for the agency in recent years as new techniques have led to a cascade of information on associations between disease conditions and individual genetics.

Among other efforts, the FDA's Critical Path Initiative is focusing on technologies that analyze the expression of thousands of genes. The technologies may make it possible to identify biomarkers to tell physicians much more about a person's risks or benefits for a certain condition or a certain medication.

Appointed to the new position of "Senior Genomics Advisor" is Liz Mansfield, who was previously with the agency's Center for Devices and Radiological Health.

The announcement was made by Frank Torti, MD, MPH, the acting FDA commissioner. There has been much speculation, but no word yet as to who will be the new FDA head under the Obama administration.

Dr. Torti said, "The FDA's emphasis on a coordinated genomics effort is the outcome of the June 2008 FDA Symposium and Retreat on Genomics, the recommendations of FDA's advisory Science Board, and our own internal planning."

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