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New OIVD Director Says FDA May Need To Go Back To 'Square One' on IVDMIA Guidance


By Turna Ray

WASHINGTON, DC — Ongoing healthcare reform debates and new leaders at the US Food and Drug Administration have led to uncertainty about how the agency will regulate drugs and diagnostics going forward, according to a high-ranking FDA official.

Specifically, with regard to the much anticipated final guidance on FDA's regulation of in vitro diagnostic multivariate index assays, health regulators may have to go back to "square one," said Alberto Gutierrez, director of FDA's Office of In Vitro Diagnostic Device Evaluation and Safety.

Gutierrez was appointed the new OIVD director in July. He took over the position from Steven Gutman, who stepped down from the director post last year.

"There is a lot of uncertainty because healthcare has runaway costs and this administration [of President Barack Obama] wants to do something about it," Gutierrez said during a conference here on next-generation diagnostics hosted by Cambridge Healthtech Institute.

Whatever form the healthcare system ultimately takes, it "will impact how things are done for everyone," Gutierrez said, adding that currently "it is difficult to say where [the FDA] will end up." He noted, that the agency is expecting "some major changes," but did not elaborate.

Particularly with regard to issuing a final guidance on IVDMIAs, a subset of algorithm-based laboratory-developed tests, health regulators may need to go back to the drawing board.

Although CMS has oversight over the majority of LDTs, for several years the FDA has expressed its intent to regulate this complex subset of tests. The agency has held a public hearing and issued two draft guidances with regard to IVDMIA regulation. Proponents of this policy feel FDA regulation of IVDMIAs would ensure the safety of such tests. Meanwhile, detractors feel that the added oversight will stifle innovation and deter investment in genetic tests for rare conditions [see PGx Reporter 08-01-2007].

The overarching issue of whether FDA should expand its oversight over lab-developed genetic tests is a divisive matter in itself. The Washington Legal Foundation in 2006 submitted a Citizen Petition challenging FDA's authority to regulate LDTs, while Genentech last year filed its own Citizen Petition recommending the FDA regulate all predictive genetic tests.

The FDA has not yet responded to either Citizen Petition. However, at this week's meeting Gutierrez said that the regulation of diagnostic tests is "a big issue" for the FDA and is "going to have to be dealt with."

Gutierrez acknowledged that the dual regulatory pathway — through CMS under the Clinical Laboratory Improvement Amendments and through the FDA — creates "an uneven playing field" for diagnostics developers.

"This is really creating havoc out there and we have to move the field one way or another," Gutierrez said. He added that the FDA hopes to engage stakeholders and the healthcare community in finding a solution for this problem and moving toward a more equitable regulatory system.