A new President, a new Congress and the path to personalized medicine

On 20 January 2009, a jubilant crowd of almost 2,000,000 spectators jammed shoulder-toshould er on the National Mall in Washington [DC, USA] to witness the inauguration of Barack Obama as the 44th President of the USA. As well as the many other historic firsts that day, a milestone was reached that went l ittle noticed except by relatively few health policy aficionados – America had inaugurated its first President for the era of personalized medicine. This distinction rings true, not so much because President Obama’s term of office coincides with a time of unprecedented understanding of the human condition at a molecular level – though that is certainly the case – but more because the new President, joined by many congressional leaders and other key policymakers, both understands and endorses the scientific and e conomic rationales of p ersonalized medicine. On Capitol Hil l (DC, USA), the 111th Congress will be considering a number of personalized medicine-centric proposals in addition to a major undertaking to enact systemic healthcare reform. The regulatory agencies, especially the US FDA and the Centers for Medicare and Medicaid Services (CMS [MD, USA]), will also be making important decisions that will have an impact on both the approval of new therapeutics and diagnostics, as well as reimbursement for their costs. In the research community, new technologies will debut, the costs of genome-wide association studies will continue to decline and genomic discovery will continue at a prolific pace. All of these scenarios will be closely watched by the private sector, the private insurers and investors in a volatile global economy.