American Association for Clinical Chemistry
Better health through laboratory medicine
May 2007 Clinical Laboratory News: Washington Profiles

May 2007: Volume 33, Number 5

Leavitt Outlines Personalized Healthcare Plan

In late March, Department of Health and Human Services (HHS) Secretary Michael Leavitt announced an initiative to combine gene-based medical care with healthcare IT. “Personalized healthcare will combine the basic scientific breakthroughs of the human genome with computer-age ability to exchange and manage data,” he said in a speech before the annual meeting of the Personalized Medicine Coalition, a nonprofit group comprised of academic, industrial, provider, and payer members from the healthcare field. “Increasingly personalized medicine will give us the ability to deliver the right treatment to the right patient at the right time—every time.”

Leavitt outlined steps that HHS will take to implement this Personalized Health Care plan. These include reviewing existing structure for ensuring that genetic tests are accurate, valid, and useful, as well as ensuring that responsibilities are clearly and appropriately assigned among HHS agencies to support useful genetic testing for patients. In addition, the HHS American Health Information Community (AHIC) will develop recommendations to identify health IT standards for information on electronic health records. AHIC is charged with recommending consensus standards to achieve President Bush’s goal that most Americans have electronic health records by 2014.

Efforts by HHS agencies supporting personalized healthcare will total $277 million this year, with this figure expected to climb to $352 million next year, said Leavitt. In addition, the FDA’s Critical Path initiative is organizing work across 76 science and regulatory areas to improve product development, especially for gene-oriented drugs and diagnostic tests. In the fall, the agency is planning to publish a regulatory guidance on the co-development of drugs and diagnostic products. Additional information on the Personalized Health Care plan is available online.

Secretary’s Committee Releases Pharmacogenomics Report

The Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) is seeking public comments on a draft report to HHS Secretary Leavitt titled Realizing the Promise of Pharmacogenomics: Opportunities and Challenges. This report focuses on opportunities and challenges in three areas of pharmacogenomics: research and development; “gatekeepers” or those involved in facilitating the progression of pharmacogenomics; and implementation of pharmacogenomics to improve outcomes in clinical and public health practices. The report includes draft recommendations in each of these areas. Among its recommendations, SACGHS suggests that HHS improve efforts to translate new scientific knowledge into clinically useful pharmacogenomic technologies and to assess their clinical validity and utility; encourage the FDA to draft a co-development guidance on pharmacogenomic drugs and diagnostics; and ensure that clinically validated pharmacogenomic test results are included in electronic medical record systems to enhance appropriate test use and interpretation.

SACGHS is requesting comments on the draft report and recommendations by June 1, 2007. Specifically, the committee would like to hear feedback on whether the topics and issues in the report are accurate and complete; whether any significant opportunities, challenges, or other issues have been missed; whether the draft report adequately describes the range of perspectives on the issues; and other strategies for addressing the issues. The report is available online. Comments should be addressed to Reed V. Tuckson, MD, SACGHS Chair, and sent to Suzanne Goodwin by e-mail, or faxed to 301-496-9839.

Institute of Medicine Calls for Integrated Biomarker Development

Research and development of cancer biomarkers is currently hindered by piecemeal and unorganized efforts, according to a recent report from the Institute of Medicine. Federal agencies, academic scientists, private industry, and other stakeholders who fund research need to take a more coordinated approach to research and development of biomarker diagnostic tests, recommends the report. In addition, progress in this field has been further slowed by the current patchwork of standards for clinical use of cancer biomarkers and unclear regulatory authority over the field.

The report also recommends the creation of an international research consortium made up of pharmaceutical and diagnostic companies and federal agencies. “On the whole, government agencies and other stakeholders should cooperate to create guidelines for the development, validation, and use of biomarkers,” the report says. “The number of false results generated by widely used biomarker-based tests for breast cancer underscores the need for uniform standards to validate tests and for greater regulatory oversight of tests once they reach the market. No federal agency now takes responsibility for ensuring the clinical validity or usefulness of biomarkers.” A full copy of the report, Cancer Biomarkers: The Promises and Challenges of Improving Detection and Treatment, is available through the National Academies Press Web site.

Obama Introduces Personalized Medicine Legislation

Senator Barak Obama (D-Ill.) recently introduced the “Genomics and Personalized Medicine Act of 2007 (S.976),” which would expand and accelerate genomics research and lay the foundation for possible regulation of laboratory-developed tests. This bill is similar to legislation Sen. Obama introduced during the previous session of Congress.

If enacted, S.976 would create an HHS interagency working group to coordinate personalized medicine activities within the department and with private sector entities; establish a national bio-banking database for collecting and integrating genomic data; allocate funds for improving the quality of genetics and genomics education and training; provide funding for a National Academy of Sciences study to identify incentives for encouraging the development of companion diagnostics tests; initiate an Institute of Medicine study to identify improvements in federal oversight and regulation of genetic testing; and determine and implement fair and reasonable coverage and reimbursement rates for genetic testing within a budget neutral environment. Additional details on this legislation are available online on THOMAS, the congressional Web site.