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The Food and Drug Administration (FDA) should develop a more transparent, systematic, and risk-based approach to regulating genetic tests, Center Law and Policy Director Gail Javitt told FDA officials at a recent meeting. The agency needs to develop a more holistic approach to genetic testing, she said, “rather than engaging in piecemeal regulatory strategy.”
Speaking at a public FDA meeting on February 8 on the agency’s recent draft guidance document addressing in vitro diagnostic multivariate index assays (IVDMIAs), Javitt reiterated the Center’s longstanding concern that the current regulatory milieu surrounding genetic tests threatens public health and private innovation. Javitt noted that FDA’s draft guidance is “an important first step in articulating the agency’s role in ensuring the safety and effectiveness of genetic tests,” since better oversight of tests’ validity is sorely needed to protect human health. Nevertheless, the document raises several concerns, she said.
Currently FDA regulates only a handful of genetic tests, those sold as “test kits” that laboratories buy off-the-shelf from manufacturers. Before marketing a test kit, manufacturers must show that the test is both analytically and clinically valid – that is, it detects the gene or gene marker it purports to detect, and that test results contain meaningful information about a person’s health.
Many laboratories, however, assemble their own tests, so-called “home brews,” which have not needed FDA approval. But in September 2006 the agency issued a draft guidance extending its enforcement to a subset of home brew tests it dubbed IVDMIAs. These are tests that measure multiple analytes, use algorithms to generate diagnoses, and require help from the test developer to interpret results. Examples of IVDMIA tests include those used to diagnose and guide treatment decisions for breast cancer, prostate cancer recurrence, and cardiovascular disease. In talks since the draft guidance was issued, FDA representatives have explained that without regulation, IVDMIAs are a “black box,” since health care providers cannot interpret the results without information from the test provider.
The draft guidance, which represented a major shift in FDA’s role, caused consternation in the industry. “The definition of IVDMIAs is itself quite fuzzy, leaving some to wonder whether their tests are or are not IVDMIAs,” noted Javitt in her presentation. Unless the agency makes its expectations clear and predictable, it could easily stifle development of new tests, she said.
Another problem is FDA’s very rationale for beginning to regulate IVDMIAs, Javitt said. “While certain intended uses of IVDMIAs will no doubt put them in an elevated risk category, we are concerned that FDA’s piecemeal approach overlooks other high risk tests that do not fall within the IVDMIA framework, while at the same time inappropriately categorizing all IVDMIAs as inherently more risky than other diagnostic tests based on the technology used,” she explained.
Finally, she questioned the use of a draft guidance document to introduce such a significant change, expressing hope that “FDA’s subsequent interactions with the regulated industry will be characterized by greater notice and explanation regarding FDA’s regulatory intentions.”
Read Javitt’s full testimony
Read the draft guidance on IVDMIAs
Read the “FDA regulation of genetic tests” issue brief
Read the article “Hudson participates in forum on FDA draft guidances”
