Details Emerge for President's Precision Medicine Initiative

02 February 2015 Personalized Medicine Bulletin Blog

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.

Initial Key Investments in Genomics and High Tech

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.

Building a Health Information Highway

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.

This blog is made available by Foley & Lardner LLP (“Foley” or “the Firm”) for informational purposes only. It is not meant to convey the Firm’s legal position on behalf of any client, nor is it intended to convey specific legal advice. Any opinions expressed in this article do not necessarily reflect the views of Foley & Lardner LLP, its partners, or its clients. Accordingly, do not act upon this information without seeking counsel from a licensed attorney. This blog is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Communicating with Foley through this website by email, blog post, or otherwise, does not create an attorney-client relationship for any legal matter. Therefore, any communication or material you transmit to Foley through this blog, whether by email, blog post or any other manner, will not be treated as confidential or proprietary. The information on this blog is published “AS IS” and is not guaranteed to be complete, accurate, and or up-to-date. Foley makes no representations or warranties of any kind, express or implied, as to the operation or content of the site. Foley expressly disclaims all other guarantees, warranties, conditions and representations of any kind, either express or implied, whether arising under any statute, law, commercial use or otherwise, including implied warranties of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Foley or any of its partners, officers, employees, agents or affiliates be liable, directly or indirectly, under any theory of law (contract, tort, negligence or otherwise), to you or anyone else, for any claims, losses or damages, direct, indirect special, incidental, punitive or consequential, resulting from or occasioned by the creation, use of or reliance on this site (including information and other content) or any third party websites or the information, resources or material accessed through any such websites. In some jurisdictions, the contents of this blog may be considered Attorney Advertising. If applicable, please note that prior results do not guarantee a similar outcome. Photographs are for dramatization purposes only and may include models. Likenesses do not necessarily imply current client, partnership or employee status.

Related Services

Insights

Hatch Comments on DNC-Related Construction Projects in Milwaukee
14 June 2019
Milwaukee Business Journal
Bernard Quoted on Debt-Relief Settlement with ITT Tech Lender
14 June 2019
Wall Street Journal
Dodd and Daughter Profiled in Wisconsin Golf
13 June 2019
Wisconsin Golf
Brinckerhoff Comments on SCOTUS Ruling in Patent Case
11 June 2019
Intellectual Property Magazine
Review of 2020 Medicare Changes for Telehealth
11 December 2019
Member Call
2019 NDI Executive Exchange
14-15 November 2019
Chicago, IL
Association for Corporate Counsel Annual Meeting 2019
27-30 October 2019
Phoenix, AZ
Foley's Government Contracts Annual Update
16 October 2019
Liviona, MI