Exploring the Current Landscape of Consumer Genomics Proceedings of a Workshop (2020) / Chapter Skim
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5 Regulatory and Health Policy Issues
5 Regulatory and Health Policy Issues
Pages 45-56
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From page 45... ...
(McGuire) • Reasons to regulate genomic testing services include to set m etrics for analytical validity, clinical validity, and clinical utility; to set standards for the comprehensibility of the infor mation provided to consumers and access to that information; and to protect and promote public health.
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From page 46... ...
Amy McGuire, the Leon Jaworski Professor of Biomedical Ethics and the director of the Center for Medical Ethics and Health Policy at the Baylor College of Medicine, focused her presentation on data sharing, privacy, and security. Gail Javitt, a member of the health care and life sciences practice at Epstein Becker Green, discussed the regulation of consumer genomics, and Jordan Laser, the senior director of cytogenetics and molecular pathology at the Long Island Jewish Medical Center and the chair of the professional relations committee of the Association for Molecular Pathology (AMP)
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From page 47... ...
In 2008 Congress passed the Genetic Information Nondiscrimination Act (GINA) , which prohibits health insurers and employers from using genetic information, including family health histories, for discriminatory purposes.
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From page 48... ...
Finally, she said, there are many states that have state-specific laws that provide even broader protections against genetic discrimination, with California having the most comprehensive state law. Turning to the emerging issue of law enforcement access to consumer genomics information, McGuire shared the story of the search for a serial rapist, murderer, and armed robber who terrorized California between 1974 and 1986, known to law enforcement and in the media as the Golden State Killer.
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From page 49... ...
At some point, trade-offs need to be made, McGuire said, and the conversation today is about how to make those trade-offs in a responsible and ethical manner. REGULATION OF CONSUMER GENOMICS There are three critical questions regarding the regulation of DTC genomic tests, Gail Javitt said: what to regulate, for what purposes regulations are needed, and who should do the regulating.
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From page 50... ...
, Javitt said, although FDA has, in limited circumstances, sent warning letters to specific laboratories objecting to specific LDTs. The FTC is responsible for regulating advertising and promotional claims under its authority to prohibit unfair trade practices, including the use of deceptive advertising.
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From page 51... ...
Subsequently, in 2010 FDA announced it would regulate DTC genomic tests and companies and that all DTC genomic tests that provided health information in the absence of FDA review were unlawful. As a result, Javitt said, a number of companies changed their business models.
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From page 52... ...
. practices" for pharmacogenomics testing aThe full text from the FDA safety communication warning regarding the use of genetic tests with unapproved claims to predict patient response to medications from October 2018 is available at https://www.fda.gov/medical-devices/safety-communications/fda-warns-againstuse-many-genetic-tests-unapproved-claims-predict-patient-response-specific (accessed December 10, 2019)
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From page 53... ...
AMP remained neutral regarding ancestry testing, deciding that such information posed little risk to the consumer and might lead to an increase in genetic literacy among the public. The group did oppose consumer genetic testing for which the company would then offer secondary services, such as vitamins, movies, and books, that were targeted to specific individuals, he said.
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From page 54... ...
For example, Laser said, California has its own expanded version of GINA that also covers emergency medical services, housing, mortgage lending, education, and other state-funded programs. DISCUSSION Regulatory Gaps for Direct-to-Consumer Genomic Tests Vicky Pratt asked where the regulatory and privacy gaps for consumer genomics are.
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From page 55... ...
Many consumers may not be aware of third-party companies that offer to interpret the raw data from DTC genomic tests, Pomerantz said, and she asked the panelists how those companies are regulated and by whom. Companies that interpret raw DTC genomic data but do not actually perform the sequencing (sometimes referred to as dry laboratories)
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From page 56... ...
Perhaps cascade screening would be more effective and easier if it were conducted through the DTC genomics companies instead of within the health care system, because the companies are often not considered covered entities under HIPAA and therefore have more freedom. Many companies may still have confidentiality and privacy rules laid out in their terms and conditions, McGuire said, so any contact of family members would have to abide by those rules.
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