Promotion of Precision Medicine Under Imprecise Rules

Food and Drug Law Institute Update

When President Obama announced the Precision Medicine Initiative (PMI) during the 2015 State of the Union Address, it set in motion a panoply of research and regulatory activities in pursuit of the initiative's stated mission: to "enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized care." A defining feature of precision medicine is the ability to use genetic information about an individual patient to make personally-optimized treatment decisions regarding that patient's disease or condition.2 This aspect of Precision Medicine is also referred to as "personalized medicine" or "pharmacogenomics."3

As we discuss in this article, to achieve the full revolutionary potential of Precision Medicine, drug manufacturers and genetic test makers must be able to easily, rapidly, and broadly communicate new treatment-related information to doctors, patients, and healthcare institutions. Yet, despite decades of research and publicity already dedicated to this issue, and the President's high-profile call-to-action with the PMI, it remains far from clear that Precision Medicine can truly meet its lofty expectations if it must do so under the government's historically restrictive policies governing the promotion and advertising of medical products, and the continuing uncertainty regarding broader elements of the federal government's regulatory approach to Precision Medicine.4

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