The White House is proposing $215 million in new funds and new regulations in a sweeping effort involving the National Institutes of Health, the Food and Drug Administration, and the Office of the National Coordinator for Health Information Technology to help fulfill the promise of what President Barack Obama has termed precision medicine.
“Precision medicine has given us one of the greatest opportunities that we have ever seen in medical research,” said Obama at a White House event kicking off the initiative. “The time's right to unleash a new wave of advances in this area.”
The bulk of investment, $130 million, will be devoted to the NIH, which will stitch together existing cohorts of genomic database and recruit new volunteers in an effort to create a million-patient-strong cohort.
Another $70 million will go to the NIH's National Cancer Institute, to scale up current efforts to link genomic variation and cancer, along with potential treatments. The head of the NIH, Dr. Francis Collins, said during a conference call Thursday announcing the policy that the investment reflects the relative maturity of genomic efforts in cancer treatment.
The FDA would receive $10 million to hire new subject-area experts. The agency, beginning with a public meeting in February, also intends to update its regulations to deal with the peculiar challenges posed by assessing the safety and efficacy of genomic sequencers and the tests that analyze their data.
The ONC would receive $5 million to promulgate new interoperability standards to make genomic data more shareable. Tales of researchers mailing thumb drives and compact discs, rather than sending data electronically, are common.
“We're far from unlocking precision medicine's full potential,” Dr. Jo Handelsman, the associate director for science in the White House Office of Science and Technology Policy, said Thursday. The intention is that the initiative will build the infrastructure that will support new insights into the genome, and consequently human health.
Obama agreed, saying that basic research sometimes fails–but when it succeeds, the payoffs are large, such as with longitudinal studies discovering the risk factors for heart disease, or federal funding setting up the later success of MRI scanning.
The NIH will be placing an emphasis on uniting private sector efforts to develop genomic cohorts. “We are aware that there are something like 200 cohorts that have at least 10,000 participants. There's a wealth of potential there,” Collins said. Central to that will be ensuring the data is interoperable, and ensuring that the data is “distributed” for easy access—rather than uniting the data centrally.
Furthermore, Collins emphasized the potential gains from ensuring that patients could be recalled. For maximum potential, he said, genomic researchers need to be able to recall patients and take laboratory measurements. That ensures a tight link between the genomic data and the eventual health outcomes of the patient, rather than a snapshot in time.
For some research, he said, it's particularly vital. Some researchers have been interested in rare genomic variants that appear to provide boosts in health, rather than lead to disease. Tracking those patients closely can allow for richer knowledge of that subset.
“We would expect that [re-contact] occurs because it makes it much more powerful,” he said.
FDA's role primarily will be in modernizing its regulations. Current diagnostics, said FDA commissioner Dr. Margaret Hamburg, tend to test for one disease or condition. That makes it easy for the agency to test the link between diagnostic and disease.
Next-generation tests, on the other hand, will tend to pass verdicts on multiple diseases, and so are more complex for the agency to assess. Starting with a February public meeting, the agency intends to mull over questions related to sequencers and tests, followed by regulatory changes.
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