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Welcome to Viewpoint.
This week the FDA created a new position in the Office of FDA’s Chief
Scientist dedicated to coordinating and upgrading our agency’s activities
involving genomics and the related fields of science that are involved in the
analysis of complex DNA, protein and small molecular expression patterns. Through
genomics, scientists are able to develop medical products and nutritional recommendations
that are sometimes called “personalized medicine” – recommendations
and therapies designed for individuals of a certain genetic makeup. Developing
products that take into account genetic makeup should increase a product’s
effectiveness and decrease the risk of harmful side effects. For
the FDA, insights gained through genomics point a way to faster and more efficient
evaluation of new medical therapies and toward enhanced food safety.
Leading this new effort at the FDA is Dr. Liz Mansfield, a scientist who has
held high level policy and scientific positions at the FDA and in the private
sector. As Senior Genomics Advisor, Dr. Mansfield will focus on the FDA’s
goal of providing FDA physicians and scientists with tools and personnel capable
of high level analysis of complex genetic data.
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.
We stand as you know on the brink of a new era of personalized medicine and
personalized health records. To help advance this progress the FDA must use
the most advanced tools for evaluating the new and frequently highly complex
products regulated by our agency. Further integration and coordination of the
latest genomic technology into the FDA’s processes and decision-making
will better protect and promote the public health.
Please check here next week for my next Viewpoint.
Frank M. Torti, M.D., MPH
Acting Commissioner of Food and Drugs |
