Industry and government officials on Tuesday began setting the stagefor next year's debate on issues surrounding genetic testing.
The first House hearing this year on genetics testing was held by theCommittee on Science's Technology Subcommittee "to provide notjust an overview of the issue but also to try to help create theframework for the upcoming Congress," said Ben Wu, a spokesmanfor Rep. Constance Morella (R-Md.), chairwoman of the TechnologySubcommittee.
"There will be a substantive look at the issue in the next Congress,"Wu said. "This is an issue that has captured a great deal of attention,both in the media and in Congress. Certainly the issue will get a lot ofplay in upcoming years."
Among those providing testimony at the hearing was AlanGoldhammer, director of technical affairs for the BiotechnologyIndustry Organization (BIO), a Washington-based lobbying group forthe biotechnology industry.
Goldhammer said genetic testing services should be regulated in amanner similar to other diagnostic methods. Genetic informationshould not be abused, he said, but at the same time privacy issuesrelated to genetic information should be no different than privacyissues for other forms of medical information.
"For this reason it is not appropriate to enact legislation that relatessolely to genetic privacy issues," Goldhammer testified. "Instead,Congress should pass a comprehensive medical privacy bill thatincludes protections for genetic privacy."
BIO also believes the Clinical Laboratories Improvements Act, orCLIA, provides the appropriate mechanisms for regulating genetictesting services, Goldhammer said, noting that it creates regulatoryconsistency between genetic and non-genetic clinical laboratoryservices. Keeping the regulation of genetic testing under CLIA wouldavoid the "inappropriate and burdensome premarket approvalrequirements that the FDA itself does not seek."
"Formal regulation by the FDA would strain the limited financialresources of the commercial and academic laboratories that aredeveloping genetic testing services and deter them from providingthese services," Goldhammer told members of the TechnologySubcommittee.
Goldhammer said existing professional societies _ such as theAmerican Society for Human Genetics and the American College ofMedical Genetics _ already have established guidelines for theproper validation, performance, use and interpretation of these tests.Most laboratories, he said, comply with those guidelines.
Wu said Rep. Morella _ whose district includes the FDA andNational Institutes of Health, as well as a number of biotechnologycompanies _ wants to be sure that results of genetic tests are accurateand not subject to misinterpretation. Inaccurate tests, either positiveor negative, could have serious emotional and physical ramifications,he said.
Morella also wants to ensure that laboratories are amenable to self-accreditation.
Goldhammer said the most practical approach to regulatingmolecular genetic testing services is to build on the already existingprofessional society standards. To address the shortcoming ofvoluntary adherence, he proposed a system that creates incentives forcompliance.
The Health Care Financing Administration (HCFA), whichadministers CLIA, "could require that clinical laboratories complywith professional society guidelines," Goldhammer said. "HCFAcurrently exercises this authority for other forms of testing, in effect,deputizing appropriate professional societies to determine whethernew tests are validated and performed in compliance with theirstandards."
Wu said Morella is inclined to weigh heavily the suggestions comingfrom a task force on genetic testing that was created by the NationalCenter for Human Genome Research, in Bethesda, Md., whichoversees U.S. efforts on the Human Genome Project. The 19-membergroup had its first meeting in April 1995. It's final recommendation isexpected in March of next year, Wu said. n
-- Jim Shrine
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