05/16/01

The Honorable Tommy G. Thompson
Secretary
Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

Dear Secretary Thompson:

We, the undersigned organizations, are requesting that you review a last-minute directive by the previous administration that greatly expands federal regulation of genetic testing. This directive, which is detailed in a January 19, 2001 letter to the HHS Secretary's Advisory Committee on Genetic Testing (SACGT) (see attachment), outlines new responsibilities for the Centers for Disease Control (CDC), Food and Drug Administration (FDA) and Health Care Financing Administration (HCFA) regarding genetic testing oversight. Our primary concern is with the new FDA duties, which overlap with existing regulations and may stifle the development and introduction of new genetic tests.

Currently, all genetic tests are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88). Laboratories conducting tests for human assessment, diagnosis and/or treatment must register with HCFA under CLIA'88, pay biannual fees, establish and conduct specified quality procedures, participate in proficiency testing (when available) and are subject to periodic inspection. Since the vast majority of genetic tests are developed and performed by clinical laboratories in-house, these tests are already subject to the most stringent standards under CLIA'88. The existing regulatory framework, which we support, currently provides effective federal oversight without hindering patient access to care or unnecessarily increasing laboratory costs. Also, there are many private sector and professional accrediting programs, currently working within the federal framework, that provide additional oversight and guidance to laboratories performing genetic testing. Therefore, we do not believe additional FDA regulation is warranted.

We are also concerned that the January 19 directive may hinder the development and dissemination of genetic testing advances by significantly expanding federal involvement in the clinical laboratory. Under the directive, laboratories developing and conducting in-house genetic tests would essentially be considered "manufacturers" and subject to direct FDA oversight-thus forcing them to meet specified regulatory requirements beyond the existing CLIA standards. Some of the recommendations, such as registering all genetic testing laboratories, are redundant since HCFA already certifies all laboratories performing patient testing, while others, such as developing and implementing a genetic testing categorization process may become very burdensome and costly and force many quality laboratories to stop performing genetic testing.

Secretary Thompson
May 16, 2001
Page Two


We, the undersigned groups, urge you to withdraw the January 19 directive and to reexamine whether laboratory quality problems really exist in the area of genetic testing, and whether such problems would be solved by increased and redundant laboratory oversight by the FDA. Our review of the situation indicates that the majority of concerns in this area pertain to the use of the data (i.e., use of data by health plans and/or employers) as well as a need for more physician and patient education (e.g., improper informed consent, tests ordered for the wrong indication and patients not fully understanding their test results), rather than in the quality of the laboratory procedure. Further, we recommend that federal agencies working in this area be advised to take no definitive actions until you complete your review.

Thank you for your consideration in this matter.

Sincerely,

American Association for Clinical Chemistry
American Clinical Laboratory Association
American Society for Investigative
Pathology
American Society of Clinical Pathologists
Association for Molecular Pathology
College of American Pathologists


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