GenomeWeb
October 29, 2019
NEW YORK – The National
Council on Disability has issued a new report, calling for more regulation of
genetic testing, especially noninvasive prenatal testing.
The nonpartisan, US government
agency made specific recommendations for Congress and federal authorities,
including the Food and Drug Administration, the Federal Trade Commission, and
the Centers for Medicare and Medicaid Services. The recommendations are
"aimed at greater federal and state oversight and quality control of
genetic tests, and improving genetic counselor education on disability,"
NCD Chairman Neil Romano wrote a letter presenting the report to President
Donald Trump.
Among the council's specific
recommendations were that Congress write new "sunshine and conflict of
interest" laws disclosing financial relationships between genetic
counselors, healthcare providers, and commercial laboratories; that FDA
"end enforcement discretion and regulate laboratory-developed tests,
specifically, noninvasive prenatal screening, to establish and enforce
standards for the accuracy of any claims made by prenatal genetic testing
entities"; and that the FTC conduct more oversight of the marketing claims
and business practices of genetic testing companies.
"The existing 'hands off'
status quo is not an option in the highly dynamic, profit-driven field of
genetic testing. The rapid pace of genetic technology, and the willingness of
'rogue' scientists to experiment with human subjects force scientists,
academics, and members of the public to confront a foundational question: Do we
control genetic technology, or does it control us?" the report said.
The report, titled "Genetic Testing and the Rush
to Perfection," is the third of a five-part series on bioethics
and disability the NCD is releasing between Sept. 25 and Nov. 20. Other reports
are entitled "Organ Transplant Discrimination Against People with
Disabilities," "The Danger of Assisted Suicide Laws,"
"Quality-Adjusted Life Years and the Devaluation of Life with a
Disability," and "Medical Futility and Disability Bias." Parts
of the report echo earlier concerns about genetic testing, including past FDA
proposals to evaluate LDTs for both
analytical and clinical validity.
NCD also detailed concerns about
the genetic testing market, including "inadequate training in disability
cultural competence" for genetic counsellors, the lack of recognition for
genetic counselors by CMS and their inability to be reimbursed by Medicare and
Medicaid, and the use and security of confidential genetic information held by
private entities.
The report stated that the
recommendations are intended to ensure that "providers and patients get
accurate, balanced information about the medical and social functional needs
that come when a child has a specific genetically inherited condition."
"Genetic testing offers the
world an abundance of information, but that information isn't often
contextualized with lived experience," NCD Council Member Jim Brett said
in a statement. "Ensuring the entire process of genetic testing —
recommending it and interpreting it — doesn't perpetuate misinformation about
disability is key."
This article was originally
published in GenomeWeb.
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