FDA should be responsible for review, approval and labeling of genetic tests

GlaxoWellcome ( think FDA reg of pharmacogenetics testing re: drug development approp but not to pharmacogenetic issues of drug safety, efficacy and post-marketing surveillance of medicines until evidence is as approp as for other types of tests

Ellen Wright Clayton (academic) – but SACGT should acknowledge effect of fear of litigation’s effect on guidelines)

Oncology Nursing Society (but also coordination of other government agencies)

National Society of Genetic Counselors (strongly concur FDA be lead agency; thinks genetics advisory panel should be appointed to work w/FDA to develop screening system re: level of oversight and estab of appeals process; incorporate requirement re: level of counseling req’d for each test)

American Association of Clinical Chemsistry (focus FDA oversight on predictive genetic tests; include reps from biotechnology and laboratory communities in deciding what tests high/low scrutiny and how process structured)

AMA (but FDA needs substantial new resources to review in timely fashion; suggests public-private consortium – like SACGT to regulate broad issues; post-market data collection could compromise privacy/confidentiality; pre-market data may delay easy access)

Academic (Holtzman, MD, MPH) (also post-market data collection; genetic tests under development, esp predictive, should be treated as “significant risk devices” requiring FDA-approved IDE app; pro-requiring data on clinical validity of existing genetic tests on market)

Consumers, Genetic Alliance (patient/advocacy group –think that lay advocacy groups should be included in any consortium and = say as professional orgs re: oversight)

NeoGeo Screening – recommend that lab directors be involved in committees for oversight of genetic testing

Vysis (not explicitly for, but thinks not FDA’s role consider social issues, better coordination btw fed agencies needed; no FDA approval for ones already on market; only very streamlined, non-burdensome oversight and include manufacturer reps to address overall societal concerns; => regulate as do other methodologies)

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)

Genzyme 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

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)

Physician (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

BIO (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)

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)