The White House July 6 announced a series of steps to advance the administration’s Precision Medicine Initiative (PMI), including $55 million in awards in fiscal year 2016 by the National Institutes of Health (NIH). The NIH investment is geared toward creation of a secure infrastructure for the PMI and recruitment of the million-person research cohort, through awards for a network of Health Provider Organizations, a Data and Research Support Center, and a Participant Technologies Center. NIH will also partner with the Department of Veterans Affairs to help enroll participants from its Million Veteran Program, which is currently comprised of over 490,000 individuals, directly into the PMI.
An additional aspect of the PMI is focused on modernizing the regulatory framework for research. As part of these new policies, the FDA released two new draft guidances on next generation sequencing-based tests, with the intention of promoting innovation and ensuring the tests are safe and effective for use in personalized medicine.
President Obama expressed support for the new initiatives and the PMI in an opinion piece, stating, “One of my administration’s proudest accomplishments has been expanding access to affordable health care to 20 million Americans. Now we’re working to ensure more people will also have access to the information that makes their health care more effective. It won’t happen overnight, but we’re standing once again at the doorstep of discovery.”