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FDA Embraces Personalized Medicine

Food and Drug Administration Acting Director Frank Torti announced Monday in a podcast the creation of a new position in the Office of Chief Scientist: the Senior Genomics Advisor. Dr. Liz Mansfield, a scientist who has worked on scientific policy at both the FDA and in the private sector, will be the first to fill the post. Dr. Mansfield “will focus on the FDA’s goal of providing its physicians and scientists with tools and personnel capable of high level analysis of complex genetic data,” according to a transcript of the podcast. The position is significant because it heralds the FDA’s focus on developing approaches to personalized medicine.

Already, the FDA runs the Critical Path Initiative, which aims to enhance the product development process by incorporating new tools for product evaluation. These include biomarker assessments, which aim to correlate the presence of certain genes or proteins to the likelihood that a patient will respond to a new medical product. And just a few months ago, the FDA entered into a partnership with Medco, a pharmaceutical benefits manager for more than one fifth of the American population, which can give the FDA access to a plethora of de-identified patient information on tests, prescriptions, and clinical outcomes. The partnership provides an economical alternative to clinical trials, as Medco can data mine reimbursement claims from very large, diverse, real-world cohorts. From this data, Medco and the FDA can then infer the predictive power of genetic tests and identify dosing trends—knowledge extremely valuable to personalized medicine as a whole, because the FDA can then issue more clinically effective guidelines for drug administration.

Unfortunately, dramatic changes will be necessary before the U.S. healthcare system can fully incorporate personalized medicine into everyday clinical practice. Two major priorities include: adoption of digital health records and a reformed reimbursement process that rewards positive clinical outcomes instead of just additional procedures and tests. Last year the Department of Health and Human Services put together a small group called the Personalized Healthcare Initiative which issued a 300-page report on personalized medicine. Additionally, the Secretary’s Advisory Committee on Genetics, Health, and Society, or SACGHS, at HHS also released a behemoth report on pharmacogenomics. It is time for HHS to start taking comprehensive action and coordinate across relevant agencies: from the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services, to the NIH and the Agency for Healthcare Research and Quality.

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