Personalized medicine has a friend in high places. President Obama recently announced an initiative to support “precision” or personalized medicine. In very general terms, the President stated during his 2015 State of the Union address that he wanted the United States to lead a new era of medicine – an era that delivers the right treatment at the right time.
Late last week, the Obama administration reported that consistent with his State of the Union announcement, $215 million will be committed from his 2016 budget for this precision or personalized medicine initiative. The major benefactors of the funds will be the National Institutes of Health (“NIH”), the Food and Drug Administration (“FDA”) and the Office of the National Coordinator for Health Information Technology (“ONC”). The White House’s fact sheet provides more details on how and why this money will be invested.
The initial investments will support the generation of a database of genetic information and its use to identify genomic drivers of disease such as cancer. According to Science magazine, NIH Director Dr. Francis Collins stated that the centerpiece of the President’s initiative will be a longitudinal research cohort consisting of at least 1 million volunteers. The volunteers will be asked to contribute diverse information, such as medical records, genetic profiles, information related to the patient’s microbiome, clinical chemistry, lifestyle information, and patient-generated information from patient’s personal devices. In addition to collecting genetic and clinical information from volunteers, the project will leverage existing research and clinical networks and allow patients to be active participants and partners in the study.
The NCI will receive $70 million to scale up efforts to identify genetic markers related to cancer therapy and to create a national “cancer knowledge network” to share information from these studies. Ten million dollars is pledged to FDA to support additional hiring and the development of high quality, curated databases and to create new regulatory structures needed to further personalized medicine. FDA will also develop a new approach for evaluating Next Generation Sequencing technologies.
Protection of the flow and access of this information is key to collecting this information from volunteers. To help secure and protect patient privacy, ONC will receive $5 million to create interoperability standards and requirements that support reliable and secure exchange of data between users and patients.
The President’s plan is audacious and bold, and may be the foundation for America’s health information highway. The collection of a significant base of patient information – genetic, clinical and lifestyle – has the potential to overcome some of the limitations of current approaches that evaluate one or a few data points in too few individuals. For the most part, these smaller, siloed studies have failed to identify reliable diagnostic or prognostic biomarkers. Support of FDA’s use of Next Generation Sequencing technology and the creation of new regulatory procedures that use genetic information from large scale analysis of data should reduce the cost and time to approve new drugs. Confident that their health data is secure and private, patients can become active participants and may more readily share sensitive health information.
Much work needs to be done, but the President’s plan and support is an important first step.
Let’s Talk Compliance | Provider Relief Fund: Reporting Requirements and Compliance Concerns