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Sen. Gordon Smith (R.-OR) convened a public roundtable June 12 to discuss regulatory, scientific and ethical issues relating to genetic testing. The roundtable fell nearly two years after Sen. Smith chaired a hearing to discuss disturbing findings by the Government Accountability Office regarding nutrigenetic tests sold over the Internet. In the letter announcing the June 12 event, Sen. Smith noted that many in the scientific and regulatory community “are concerned that DTC [direct-to-consumer] genetic tests may shock and misinform consumers.”
Roundtable participants included Center Director Kathy Hudson; Thomas Hamilton, director of the Survey & Certification Group at the Centers for Medicare & Medicaid Services (CMS); Judy Yost, director of the Division of Laboratory Services / CLIA Program at CMS; Steven Gutman, director of the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) in the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA); Catherine M. Cook, acting associate director for regulations and policy in the CDRH at the FDA; W. Gregory Feero, senior advisor to the director for genomic medicine at the National Human Genome Research Institute at the National Institutes of Health; Elaine Lyon, associate professor of clinical pathology at the University of Utah School of Medicine and medical director of Molecular Genetics at ARUP Laboratories; and Linda Avey, co-founder of the genetic testing company 23andMe.
Sen. Smith opened the discussion by laying out three critical issues for discussion: whether consumers have adequate assurance regarding the accuracy and reliability of genetic tests; whether the privacy of test results is adequately protected; and whether CMS oversight of laboratories is adequate.
Hudson noted that since Sen. Smith’s hearing in 2006, nothing had really changed on the regulatory front, a statement with which Lyon disagreed. Gutman and Yost noted that there was more informal collaboration between the agencies, and Yost said CMS had been working on a best practices guide with CDC. However, Gutman acknowledged that FDA “has not made much progress” on genetic test regulation, with the exception of issuing a draft guidance addressing in vitro diagnostic multivariate index assays [http://www.dnapolicy.org/news.release.php?action=detail&pressrelease_id=56], a subset of genetic tests.
Sen. Smith asked whether it would help the agencies if Congress provided more authority through new legislation. Gutman responded that while FDA has sufficient authority, legislation could give the agencies more direction and would be a way for Congress to express its interest in genetic testing oversight. He noted that independent review of genetic tests is valuable, whether it is performed by FDA or another entity, and that more transparency is needed regarding the data underlying marketed tests. Hamilton and Yost responded that their current authority (under the Clinical Laboratory Improvement Amendments) is adequate. They stated that CMS intends to update current regulations to require some genetic testing laboratories to enroll in proficiency testing programs. Despite repeated questioning, they did not provide a timeline for doing so.
Sen. Smith asked Avey whether the DTC industry is developing “best practices” for offering tests to consumers. She responded that more regulation was needed and that she had been “horrified by what other companies are doing.” At the same time, she noted that it is important not to “stymie the research.” Senator Smith asked how her company distinguished itself from those selling “snake oil.” She responded that 23andMe presents results to consumers as research only. Gutman disagreed, stating that the company was making health claims on its Web site. Avey also was questioned about whether 23andMe follows accepted practices governing research with human subjects. She affirmed that such practices were followed, although it was unclear from her statements whether the company had received approval from an institutional review board for its research activities. She also noted that participation in research by customers was voluntary.
Feero noted that while genetic research had yielded “robust associations” between certain genetic variations and disease risk, the predictive value of such associations was “meager.” Hudson noted that the most worrisome DTC tests were those that could result in important health-related decisions.
Among those present in the audience was Matthew Daynard, senior attorney in the FTC’s Bureau of Consumer Protection, Advertising Practices Division. Daynard was questioned about FTC’s authority over false and misleading claims and its activities with respect to DTC testing companies. He responded that the FTC has broad authority to prohibit false and misleading marketing claims and revealed that the FTC is currently involved in two investigations of DTC genetic testing companies.
Participants also were asked to respond to the recent report issued by the Secretary’s Advisory Committee on Genetics Health and Society, which identified significant gaps in genetic testing oversight and made numerous recommendations to address these gaps. Several participants praised the thoroughness of the report. Hudson said that the recommendations to require that genetic testing laboratories enroll in proficiency testing and to develop a mandatory genetic testing registry should be top priorities for implementation. – Gail Javitt
