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Round two on genetic testing
More public comment sought on oversight policy
Edward R. Winstead

There's still time to tell an advisory committee what you think about genetic testing and how these tests should—or shouldn't—be regulated in the United States. The committee has completed a review of genetic testing and will be recommending further oversight for all gene tests in its final report later this year. A draft of the report has been posted on the Internet for public comment until May 22, 2000.

The Secretary's Advisory Committee on Genetic Testing was created in 1998 by the Department of Health and Human Services to consider a range of issues related to this new area of medicine. The chairman of the 13-member panel is Edward McCabe, professor and chair of the department of pediatrics, the University of California at Los Angeles.

The committee has gotten the message that people are concerned about employers and insurance companies using genetic test results to discriminate against them. This was a theme at a public meeting in Baltimore in January and in some 400 messages the committee received through its office and Web site. In February, President Clinton issued an executive order barring the use of gene tests in the hiring or firing of federal employees.

The public's concerns are addressed in the report, "Adequacy of Oversight of Genetic Tests." The committee writes: "Based on the rapidly evolving nature of genetic tests, their anticipated widespread use, and extensive concerns expressed by the public about their potential misuse or misinterpretation, additional oversight is warranted for all genetic tests."

The committee is proposing that the Food and Drug Administration should be the lead federal agency responsible for reviewing, approving, and labeling all genetic tests. This would mean the agency would have to develop a relatively efficient process for evaluating different kinds of tests, since the report says that different tests warrant different oversight. For instance, tests that predict a person's chances of developing a disease require more scrutiny than do diagnostic tests, the committee writes.

At present genetic tests are available for roughly 300 diseases or conditions through some 200 U.S. laboratories, and researchers are in the early stages of developing several hundred more, according to GeneTests, a directory of clinical laboratories providing tests for genetic disorders.

The Secretary's committee will meet June 5-7, 2000 to review the comments received and develop a final report.

Below are five issues the committee has been considering since last summer. In June, Assistant Secretary for Health and Surgeon General David Satcher asked the committee to develop a report organized around these questions:

Issue 1: What criteria should be used to assess the benefits and risks of genetic tests?

Issue 2: How can the criteria for assessing the benefits and risks of genetic tests be used to differentiate categories of tests? What are the categories, and what kind of mechanism could be used to assign tests to the different categories?

Issue 3: What process should be used to collect, evaluate, and disseminate data on single tests or groups of tests in each category?

Issue 4: What are the options for oversight of genetic tests and the advantages and disadvantages of each option?

Issue 5: What is an appropriate level of oversight for each category of genetic test?

The Secretary's Advisory Committee on Genetic Testing can be reached at


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