April 9, 2007
Bipartisan bills recently introduced in the Senate have sharpened the legislative focus on federal regulation of genetic testing. Both agree that some level of oversight is needed in this fast-growing—and promising—diagnostics and therapeutics market, but the bills diverge on what that level should be and who should enforce it.
The bills are:
- S. 736, the Laboratory Test Improvement Act, sponsored by Edward Kennedy (D-MA), chairman of the Health, Education, Labor & Pensions (HELP) Committee, with ranking Republican Gordon Smith (OR) as co-sponsor, and
- S. 976, the Genomics & Personalized Medicine Act, sponsored by Barack Obama (D-IL), with co-sponsor Richard Burr (R-NC), both members of the HELP Committee.
Clinical laboratory and pathology organizations warn that more federal oversight could impede progress in personalized medicine based on genomics. Lab-developed tests (LDTs) make up a large portion of this work, the groups note, including in-house developed tests and in-house modifications of approved kits. And LDTs already are regulated for analytic validity under the highest CLIA category for lab test performance (high complexity), they note.
Different Courses to the Same Goal
While acknowledging that it is important not to stifle innovations or impede patient access, both Kennedy and Obama say federal oversight is needed to assure the analytical and clinical validity of genetic testing and to monitor direct-to-consumer marketing that makes questionable medical claims for unapproved test kits.
The Kennedy bill, S. 736, would target LDTs (also known as home-brews) as medical devices requiring premarket review by the Food & Drug Administration. This represents a "significant departure" from the current enforcement approach and "would subject thousands of LDTs to a level of regulation they have never undergone before," noted Peter Kazon, Esq., a partner in Alston & Bird, LLP, during his presentation at the LABLine audio conference sponsored April 3 by the American Clinical Laboratory Association. The paperwork alone could overwhelm both labs and the FDA, ACLA has observed.
Until last year, the FDA limited itself to regulating analyte-specific reagents (ASRs) used in LDTs. But last fall, the agency issued draft guidance on its plan to require premarket review for a specific category of widely used lab-developed tests, called in vitro diagnostic multivariate index assays (IVDMIAs), which use an assay and an algorithm to generate patient-specific results. The FDA argued that because of their novel and often proprietary nature, special oversight is needed to make sure physicians can properly interpret the results.
Under S. 736, LDTs generally would be class II devices subject to special controls. LDTs intended to screen donated blood or to diagnose a contagious disease or condition that is highly likely to be fatal would be subject to the most stringent controls, class III. The Health & Human Services Secretary would have discretion to assign an LDT to class I (general controls only) if certain safety and effectiveness requirements are met.
The bill directs the Secretary to issue guidance on the special controls to which all LDTs or subcategories will be subject. Also, labs that make class II LDTs would generally be exempt from biennial FDA inspection. Further, the bill would require LDT labeling for intended use and regulatory status, registration of manufacturers and their LDT tests, and reporting of adverse events.
Under the Obama bill, S. 976, Congress would solicit outside expert advice before further regulation of genetic testing and genomics. The HHS Secretary is to contract with the Institute of Medicine to study and make recommendations on the key issues. Once the report is submitted, the Secretary is to develop and propose a decision matrix to help labs and other test makers know which types of tests require which level of review and who is responsible for the review––CMS or the FDA, or both. The bill also requests a study by the National Academies of Sciences on incentives to stimulate advances in designing and developing new genetic testing technologies.
As Obama’s health policy advisor, Dora Hughes, MD, MPH, explained in the ACLA audio conference, the Senator’s approach is to "fashion an overall strategic plan" addressing not only federal oversight, but also the need for increased federal support for research, data collection and sharing, genomics training of the medical workforce, and monitoring of direct-to-consumer marketing practices. ACLA supports the Obama bill, noting in particular that it recognizes these "interlocking needs."
As part of this strategic plan, Hughes said, the bill would create an interagency working group to expand and accelerate genomics research in public and private sectors through enhanced communication, collaboration, and integration of relevant activities. It also would require HHS to establish a national database for genetic test information sharing.
Key Common Ground
Both the Kennedy and Obama bills would:
- Establish a CLIA specialty for genetic testing. CMS last year pulled the plug on years’ worth of work to draft a proposal for such a specialty, saying it was not practical to write hard-and-fast rules that science and clinical practice could quickly render outmoded. Nor is it clear, CMS said, how such rules could address sensitive issues typically outside CLIA purview, such as counseling, informed consent, confidentiality, and liability. Instead, the agency said it would beef up scrutiny of genetic testing labs under existing CLIA rules.
- Direct the HHS Secretary to determine if reimbursement is adequate for new genetic tests and, where appropriate, grant higher rates. Neither bill is specific, however, as to how the Secretary should proceed. Pay rates have fallen far below testing costs, creating a major barrier to patient access, the HHS Secretary’s Advisory Committee on Genetics, Health & Safety (SACGHS) has noted.
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April 9, 2007 - Table of Contents
