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Saturday, September 12, 2009


FDA Embraces Personalized Medicine

The U.S. Food and Drug Administration will create a new position in the Office of FDA’s Chief Scientist that will concentrate on coordinating and upgrading the agency’s genomics-related activities and the fields of science that are involved in the analysis of complex DNA, protein, and small molecular expression patterns.

Frank Torti, acting commissioner of food and drugs, made the announcement in early February in a podcast on the FDA’s website. The first person to fill the newly post of senior genomics advisor will be Liz Mansfield, a scientist who has held high-level policy and scientific positions at the FDA and in the private sector. In her new role, 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.

“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,” said Torti.

He noted that developing products that take into account genetic make-up should increase a product’s effectiveness and decrease the risk of harmful side effects. For the FDA, he said, insights gained through genomics point a way to faster and more efficient evaluation of new medical therapies and toward enhanced food safety.

Torti explained that 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 the agency’s own internal planning.

The creation of a new position devoted to coordinating the agency’s genomics effort is another step in the FDA’s efforts to improve its use of new technologies to promote and protect public health. In August 2008, the FDA and Medco Health Solutions, the nation’s leading pharmacy benefit manager, entered into a two-year research partnership to study genetic testing and the impact of genetics on the efficacy of prescription drugs. The agency has started talking to several personal genomics firms about possible alliances that could help the FDA track adverse drug reactions (post-marketing) by accessing the companies’ growing genomics databases, Lawrence Lesko, director of FDA’s Office of Clinical Pharmacology, said in November..

“We stand as you know on the brink of a new era of personalized medicine and personalized health records,” said Torti. “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.”

Source: The Burrill Report

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