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This page provides information concerning the Oversight of Genetic Technologies study topic.
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A list of reports and correspondence related to this topic are provided below. This page also provides a summary of the sessions concerning this topic that have been held at SACGHS meetings so you can review the transcripts, presentation materials, and webcasts for the sessions that dealt with the topic.
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Reports and Correspondence |
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SACGHS Letter to the Secretary of Health and Human Services (April 27, 2007)
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Secretary Leavitt�s response to SACGHS (Aug 27, 2007)
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U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of Health and Human Services
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SACGHS letter to the Secretary of Health and Human Services (August 18, 2008)
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Top of Page |
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SACGHS Meetings |
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February 12, 2008 - Session on Oversight |
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Overview of Report, Summary of Public Comments on Draft Report and Goals of Session |
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Andrea Ferreira-Gonzalez, Ph.D.
Chair, SACGHS Task Force on Oversight of Genetic Testing
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Overview Slides
Finalization of Recommendations Slides
Webcast
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Presentation of the Comprehensive Map |
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Clifford Goodman, Ph.D.
Senior Vice President
The Lewin Group
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Map Slide
Map Presentation Slides
Webcast
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Discussion of Final Draft Recommendations (continued)
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Webcast
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Presentation of the Comprehensive Map
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Webcast
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February 13, 2008 - Session on Oversight |
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Discussion of Final Draft Recommendations (continued - Before Break)
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Webcast
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Discussion of Final Draft Recommendations (continued - After Break)
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Webcast
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November 20, 2007 - Session on Oversight |
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Session Overview |
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Andrea Ferreira-Gonzalez, Ph.D.
Professor of Pathology and Director of Molecular Diagnostics Laboratory
Virginia Commonwealth University
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Slides
Webcast
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An International Analysis: Enhancing the Regulation of Genetic Tests through Responsive Regulations |
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Stuart Hogarth
Visiting Research Fellow
Institute for Science and Society
University of Nottingham
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David Melzer, M.B., B.Ch., M.Sc., Ph.D., FFPHM
Professor of Epidemiology and Public Health
Peninsula Medical School
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Slides
Hogarth Webcast
Melzer Webcast
Q&A Webcast
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Public Perspectives on the Oversight of Genetic Testing |
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Webcast
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July 10, 2007 - Report from the SACGHS Task Force on the Oversight of Genetic Testing |
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Marc Williams, M.D., FAAP, FACMG
SACGHS Oversight Task Force
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Slides
Webcast
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November 13, 2006 - Oversight of Genetic Technologies and Testing Labs Session |
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Session and Issue Overview |
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Dr. Tuckson (SACGHS Chair) |
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Webcast - Transcript
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Developments at CMS |
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Thomas E. Hamilton
Director, Survey and Certification Group
Centers for Medicare & Medicaid Services
Judith A. Yost, M.A., M.T.
Director, Division of Laboratories and Acute Care
Centers for Medicare & Medicaid Services
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Slides - Webcast - Transcript
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Developments at FDA |
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Steve Gutman, M.D., M.B.A.
Director, Office of In Vitro Diagnostic Device Evaluation and Safety,
Food and Drug Administration
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Slides -
Webcast - Transcript
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Questions and Answers |
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Full Committee Discussion |
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Webcast - Transcript
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June 26, 2006 - Oversight Session |
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Update on the Notice of Proposed Rule Making on a Genetic Specialty for the CLIA Program |
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Judith A. Yost, M.A., M.T.
Director
Division of Laboratories and Acute Care Centers for Medicare & Medicaid Services |
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Slides
Webcast
Transcript
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Q&A |
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Webcast
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October 22, 2003 - Oversight of Genetic Technologies, Marketing, and Laboratories and the Role of Pharmacogenetic Tests in Therapeutics |
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Oversight of Genetic Testing Laboratories Through the Clinical Laboratory Improvement Amendments (CLIA) |
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Judith A. Yost, M.A., M.T.
Director, Division of Laboratories and Acute Care
Centers for Medicare & Medicaid Services |
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Slides
Webcast
Transcript
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Plans for Augmenting CLIA to Specifically Address Genetic Testing Laboratory Issues and Concerns |
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D. Joe Boone, Ph.D.
Associate Director for Science, Division of Laboratory Systems
Public Health Practice Program Office
Centers for Disease Control and Prevention |
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Slides
Webcast
Transcript
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Roundtable Discussion |
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Facilitator: Dr. Winn-Deen |
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Webcast
Transcript
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Impact of Pharmacogenomics on Prescription Drug Labeling |
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Lawrence J. Lesko, Ph.D.
Director, Office of Clinical Pharmacology and Biopharmaceutics
Center for Drug Evaluation and Research
Food and Drug Administration |
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Slides
Webcast
Transcript
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FDA's Current Approach to the Review, Labeling and Marketing of Genetic Tests |
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Steven I. Gutman, M.D.
Director, Office of In Vitro Diagnostics
Center for Devices and Radiological Health |
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Slides
Webcast
Transcript
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FDA's Future Plans to Enhance Oversight of High Risk Genetic Tests |
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David W. Feigal, Jr., M.D., M.P.H.
Director, Center for Devices and Radiological Health
Food and Drug Administration |
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Slides
Webcast
Transcript
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Roundtable Discussion |
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Facilitator: Dr. Leonard |
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Webcast
Transcript
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FTC's Regulation of the Advertising and Promotion of Consumer Products and Its Application to Genetic Technologies |
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Matthew Daynard, J.D.
Senior Attorney, Advertising Practices Division
Bureau of Consumer Protection
Federal Trade Commission |
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Slides
Webcast
Transcript
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Roundtable Discussion Regarding FDA and FTC Regulation of Advertising and Promotion of Genetic Technologies |
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Facilitator: Ms. Zellmer |
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Webcast
Transcript
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Public Comment Session |
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Webcast
Transcript
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Continued Discussion of Oversight and Pharmacogenetics |
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Webcast
Transcript
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