Sen. Alexander Introduces Bill to Continue Implementation of Precision Medicine Initiative | GenomeWeb

Sen. Alexander Introduces Bill to Continue Implementation of Precision Medicine Initiative

NEW YORK (GenomeWeb) – Senator Lamar Alexander (R-Tenn.) introduced the "Advancing Precision Medicine Act of 2016" yesterday.

The bill, which has been referred to the Senate Committee on Health, Education, Labor, and Pensions, intends to "provide for the implementation of" the Precision Medicine Initiative (see bill PDF below).

President Barack Obama announced the launch of the PMI last year with $215 million in proposed funding. The shared health and clinical outcomes data of a million volunteers will power research within PMI, a project aimed at spurring more precise and personalized healthcare.

As part of a $1 trillion spending bill that the US Congress passed last year, legislators allotted $200 million for the initiative. And the White House announced in February that the National Institutes of Health has picked Vanderbilt University and Alphabet’s life sciences subsidiary Verily to evaluate the best ways to engage, enroll, and retain participants in the PMI cohort.

However, it could take many more funding cycles before the research within PMI starts to bear fruit. Assembling the 1 million-volunteer cohort alone is expected to take three to four years. As such, industry observers believe that additional legislation is necessary to ensure Obama's project — something he is personally involved in — is supported after he leaves office.

"The PMI bill is necessary to ensure that the effort continues after an administration change, and also coordinates the efforts of many agencies," Amy Miller, executive VP of the Personalized Medicine Coalition, told GenomeWeb. "Furthermore, authorization language is necessary in order for it to be funded."

The short bill, as introduced by HELP Committee Chairman Alexander, currently doesn't contain any language on funding. But the bill seeks to "encourage" the US Department of Health and Human Services Secretary to "carry out" the PMI and "to augment efforts to address disease prevention, diagnosis, and treatment."

The bill further suggests the HHS Secretary could develop a network of scientists; advance new approaches to address scientific, medicine, public health, and regulatory science issues; apply genomic technologies to collect data on the molecular underpinnings of diseases; and gather information from volunteers to improve understanding of diseases.

The bill also recognizes the project requires "advanced supercomputing," policies for secure data sharing, and privacy protections for research participants. The legislation tells the HHS Secretary to leverage public-private partnerships and ensure collaboration between NIH, the US Food and Drug Administration, and the Office of the National Coordinator for Health Information Technology.

All this is already being hammered out within the PMI. Notably, the NIH has launched Sync for Science to pilot open, standardized applications that individuals can use to donate their data for research. Electronic health records firms Allscripts, Athenahealth, Cerner, Drchrono, Epic, and McKesson have all pledged to deploy applications that will facilitate this within Sync for Science.

Additionally, the FDA has launched the PrecisionFDA challenge, an effort to encourage scientists to collaborate on the development of common datasets, tools, and reference standards for next-generation sequencing.

Alexander's bill seeks to ensure that these core elements continue to exist within the PMI. Most notably, the bill echoes the requirement from Obama and other leaders that the PMI cohort reflect the diversity of America. The cohort should "ensure inclusion of a broad range of participants, including consideration of biological, social, and other determinants of health that contribute to health disparities," the bill states.

The PMC applauded Alexander for introducing the bill. "We are impressed … that in an election year, policies regarding innovations to improve health can unite our nation, both houses of Congress, and the White House," Miller said.

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