Issue |
For |
Against
|
---|---|---|
FDA should be responsible for review, approval
and labeling of genetic tests
|
American Academy of Pediatrics
|
Genetic Counselor (should expand dept that
CLIA resides in, currently working on issues)
American College of Medical Genetics
(tests have significant practice of medicine components that would
be exempt from FDA oversight, worried re: FDA lack of
resources/staff will slow growth in field, think should either ask
FDA to assess all genetic tests to ID those needing increased
oversight or direct that FDA review those already identified as
needing oversight)
Academic (MS) – concerned about
length of time required to review, approve and label genetic test
(pro attention to issues re: predictive testing esp where no
medical interventions available)
American Society of Human Genetics
(concerned about FDA being lead agency and that too much regulation
will inhibit research, thinks IRB approval and informed consent
should be sufficient for genetic testing in development)
New York St Dept of Health (thinks FDA
having primary oversight => greater complexity, thinks needs
clearly defined link to CLIA permit)
Athena DiagnosticsGenzyme Genetics (existing CLIA/CAP regs
could be extended to these technologies; proposed oversight by FDA
= impracticable, if = to traditional outcomes data required of
pharmaceutical industry)
National Patient Advocate Foundation
(until problems w/genetic testing are identified, should err on
side of less rather than more fed oversight/regulation)
College of American Pathologists
(questions ability of FDA to develop flexible mechanisms for review
of genetic tests, thinks CLIA already mandates standards of review
according to complexity; but agrees re: sliding scale of review
w/more for predictive tests where no safe and effective
intervention avail; any review of tests already on market should be
done w/input of lab reps; thinks practice of genetic testing should
be governed through consensus of professional orgs; narrow
definition of genetic test to prevent over-regulation and increased
costs for tests) – Association for Molecular Pathology
endorses CAP comments!
|
Importance of Informed Consent
|
American Academy of Pediatrics
Genetic Counselor
Genetic Counselor (thinks should be for
all, not just predictive)
Oncology Nursing Society (supports
standardization of content of informed consent documents, suggests
issues to consider)
National Society of Genetic Counselors
(genetic tests requiring high oversight should require written
informed consent; genetic test inserts should contain basic
stipulations, such as imp of patient communication of tests results
to family members and info on how to locate genetics
professional)
American Association of Clinical Chemistry
(before predictive tests; labs should be able keep specimen for
clinical research if patient identifiers removed, no consent
required when using archived, anonymous samples)
Consumers, Genetic Alliance
(patient/advocacy group – written informed consent should be
required for all genetic tests)
Hypertrophic Cardiomyopathy Assoc.
(patient advocacy group thinks penalties should be imposed for
incomplete or inadequate consumer info)
College of American Pathologists –
written informed consent should be obtained for tests for
predictive purposes, but should be reviewed disease-by-disease
basis, consider medical necessity and admin burden, should be
promulgated through consortium including lab reps)
Rowley (MD Academic) –good that
informed consent SHOULD be vs Required to be obtained so as not to
deter practitioners; use “informed choice” rather than
“informed consent” – benefits and risks!)
Certified Genetic Counselor (Palmer
– replace word should with MUST for informed consent, also
informed consent for other predictive tests)
|
Orchid Biosciences – thinks once
pharmacogenetic test accepted in clinical practice, no need for
informed consent
Public member – not as much consent for
those don’t reveal inherited genetic info
Association for Molecular Pathology (not
all tests need informed consent – esp if only one component
of diagnostic evaluation; if informed consent required, lab
shouldn’t be responsible)
Academic (Stephen Cederbaum): concerned
w/requirement of informed consent for predictive testing –
DNA tests aren’t different from other predictive tests
|
Against Genetic Exceptionalism
|
Industry (believes that existing CLIA regs
should be enhanced to provide adequate quality for all medical
tests) – e.g. Orchid, BIO (con two-tiered reg system),
Genzyme Genetics, Affymetrix
Consumers, Genetic Alliance
(patient/advocacy group – broaden 4th principle to include
all medical info)
College of American PathologistsPhysician (Low)
|
College of American Pathologists (against
genetics specialty under CLIA, thinks existing regs re: highly
complex clinical lab tests enough)
|
Pro Improving CLIA regulations for genetic
testing
|
American College of Medical GeneticsAmerican Association of Clinical ChemistryBIO (pro enhancing existing regulatory
schemes like CLIA rather than creating new one)
Holtzman – Academic MD, MPH (in
applying for CLIA certification, labs should indicate tests are
developing, recently developed and HCFA should pass info to
FDA)
Athena Diagnostics,
|
|
Pro Distinction btw Predictive vs Diagnostic
Genetic Tests (less reg for latter)
|
Exact Lab (request narrowing definition of
genetic test to reflect different concerns, not impede
diagnostics)
|
|
Re: Who Develop Guidelines for Genetic Research
and Testing
|
American Association of Clinical Chemistry
(include professional societies)
|