Following up on President Barack Obama’s announcement in his State of the Union Address, the Administration unveiled details about the Precision Medicine Initiative, including plans to collect genetic data on one million Americans.
On Friday, Obama gave more details about the initiative that he originally announced during his State of the Union Address. The President is requesting that the Congress approve $215 million for his initiative designed to help physicians tailor treatments to an individual, based on their genetic make-up. The proposal will be part of the fiscal 2016 budget that Obama will submit today.
As part of the project, researchers will engage a million or more Americans to volunteer to contribute their health data to improve health outcomes, fuel the development of new therapies, and catalyze a new era of data-based and more precise medical treatment. The effort would likely combine data from patients in existing studies along with volunteers.
According to the Administration, most drugs are designed for the “average patient” under a “one-size-fits-all-approach.” This allows for drugs to be effective for the majority of patients, however may be ineffective in others. This idea has been changing recently with the emergence of precision medicine. Biotech companies are already developing drugs targeted for patients with specific genetic mutations. The US Food and Drug Administration (FDA) has approved several targeted drugs, including Kalydeco which is approved for cystic fibrosis patients with certain gene mutations. Additionally, patients with breast, lung and colorectal cancers routinely undergo molecular testing as part of the patient care.
The President’s 2016 Budget will provide a $215 million investment for the National Institutes of Health (NIH), together with the Food and Drug Administration (FDA), and the Office of the National Coordinator for Health Information Technology (ONC) to support this effort. Of the budget request, $130 million would go to the NIH for development of a voluntary national research cohort of a million or more volunteers for responsible data sharing; $70 million would go to the National Cancer Institute (NCI), part of NIH, to identify genomic drivers in cancer and apply that knowledge in the development of more effective approaches to cancer treatment; $10 million would go to the FDA to acquire additional expertise to develop databases on which to build an appropriate regulatory structure; and $5 million would go to ONC to support the development of interoperability standards and requirements that address privacy and enable secure exchange of data across systems.
For the release, click here.