Freedom of Information Act Office
IC Directors' Meeting Highlights
February 18, 2010
| To: | IC Directors |
| From: | Penny Burgoon |
| Subject: | IC Directors Meeting Highlights—February 18, 2010 |
Announcements
Dr. Collins recapitulated the news that Raynard Kington, Principal Deputy Director, will leave NIH this summer to take on the challenge as President of Grinnell College. Plans will soon be underway to recognize Dr. Kington for his accomplishments at NIH and congratulate him on this next step in his career.
Discussion Items
Focusing on the Future: Opportunities for the NIH Common Fund
Francis Collins
Dr. Collins highlighted seven new projects to receive support by the NIH Common Fund in FY2010. These projects aligned with NIH’s five areas of opportunity and received consideration from current or prior Common Fund/ trans-NIH planning. Dr. Collins thanked IC Directors and Program staff that helped to quickly develop program plans under tight time constraints to meet FY2010 program deadlines. He encouraged IC Directors to begin thinking now about Common Fund proposals for FY2011. Additionally, Dr. James Battey (Director, NIDCR) is planning a “Big Think” meeting for this spring to solicit external advice on potential new opportunities for support by the Common Fund or by normal NIH IC funding.
New Programs approved for FY2010 Common Fund are:
- Library of Integrated Network-based Cellular Signatures (LINCS)
- Protein Capture Reagents
- Global Health
- Translational Applications of Stem Cells
- Mouse Phenotyping Center
- Science of Behavior Change
- Regulatory Science
Dr. Collins outlined each program’s goals, planned initiatives, planned activities, and planned budget.
Three additional proposals on Health Economics, HMO Collaboratory research networks, and New Models for Large Prospective Studies were not ready for program implementation and could be considered for the next round of funding in FY2011. With existing Roadmap and activation of these Common Fund programs, the Common Fund budget is anticipated to be restricted in FY2010 and FY2011, but greater funds turnover is expected in FY2012-2014.
IC directors asked about exit strategies for existing Roadmap programs and encouraged Dr. Collins to develop a strategy for communication of Common Fund program outyear commitments and exit plans.
Advancing Personalized Medicine and the Creation of a
Voluntary Laboratory Test Registry at NIH
Kathy Hudson
The NIH is working with FDA and CMS to develop a harmonized, risk-based approach to oversight of laboratory testing. Improvement in oversight will protect the public and enable innovation in personalized medicine. NIH plans to develop a voluntary genetic testing registry planned and housed within NCBI/NLM.
Oversight has not kept pace with the changes in genetic testing technologies, which have increased in number, complexity, availability and clinical relevance. There are generally two different modes of genetic tests—laboratory-developed tests (LDT) and test kits—which receive oversight via a two-path system of review by either the FDA regulation of tests or the CMS regulation of testing laboratories under the Clinical Laboratory Improvements Amendments Program (CLIA). The combination of different modes of testing and dual-paths of regulation has created confusion and disparate oversight, casting uncertainty on test validity and utility. Over several years, an NIH/DOE task force and two advisory committees to the Secretary recognized problems associated with oversight of genetic testing. Testing oversight needs to be based on risk, not mode of manufacture; test validity needs to be higher; test regulation should be more transparent, and physicians need to be educated on the use and relevance of genetic testing in order to be able to practice genetic medicine.
A proposed genetic testing registry under the NCBI/NLM would improve research and public health by:
- Increasing transparency
- Increasing consumer, physician, and research access to information
- Increasing marketplace competition
- And decreasing inefficiency and redundancy for test providers and regulators
The proposed registry would be voluntary, with information submitted by test providers, and could provide an HHS-wide portal for information. There are approximately 1600 genetic tests currently available. Plans for governance and implementation of the registry include creation of a NIH Genetics Test Registry Steering Committee and solicitation of stakeholder input on registry design.
IC Directors recognized the importance of making standardized information available on genetic testing but noted that even "genetics testing " itself will have to be clearly defined from other laboratory testing. Dr. Hudson noted that an argument has been made that the registry should consider registering all laboratory tests (~5000 available). There were several concerns that establishment of a registry would raise expectations that NIH should be responsible for test quality, that registry data could be misused, that ownership of the registry could prove to be very burdensome, and that NIH test registration would be misused by submitters as brand endorsement of their test. Jim Ostell, NCBI, noted that NCBI would be able to link data to other electronic tools to provide more information to users regarding test quality. It was acknowledged that the registry would provide a useful source for developing standardized test nomenclature for clinical research and electronic health records and that the registry would be important in providing information to help the regulation efforts of sister agencies in DHHS.
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