Under New Leadership, FDA Diagnostics Office To Tighten Its Control

Full article reprinted from "The Gray Sheet" - July 27, 2009

Taking its cue from the new, more aggressive FDA administration, the agency's diagnostics office aims to tighten its regulatory control over commercial tests and, potentially, lab-developed assays, according to the new director of the Office of In Vitro Diagnostic Device Evaluation and Safety, Alberto Gutierrez. Read more...

Under New Leadership, FDA Diagnostics Office To Tighten Its Control

Full article reprinted from "The Gray Sheet" - July 27, 2009

Taking its cue from the new, more aggressive FDA administration, the agency's diagnostics office aims to tighten its regulatory control over commercial tests and, potentially, lab-developed assays, according to the new director of the Office of In Vitro Diagnostic Device Evaluation and Safety, Alberto Gutierrez.

The new FDA leadership, headed by Commissioner Margaret Hamburg and Principal Deputy Commissioner Joshua Sharfstein, plans to make "huge changes" to the way the agency implements its public health mission, Gutierrez said July 20 at the annual American Association of Clinical Chemistry meeting in Chicago.

"The new administration is feeling its way and we're going to support them," he said of the FDA diagnostics office's priorities going forward.

Companies can expect more aggressive diagnostics regulation, manifest in several ways, explained Gutierrez, who officially assumed the head role earlier this month.

Namely, the new OIVD director acknowledges flaws in the 510(k) pre-market notification program, the regulatory pathway by which many in vitro diagnostics reach the market.

The 510(k) program requires commercial test makers to establish the analytical validity, accuracy, precision and specificity of their in vitro diagnostics. It also requires some proof of clinical validity, Gutierrez said.

But the concept of "substantial equivalence," the linchpin of the 510(k) program, which allows a test maker to show its test is similar to an already cleared device in lieu of a more extensive safety and efficacy review, invites unwanted variability among test makers, he added.

"It's not anchored very well," Gutierrez said. "You get, essentially, tests that are all over the place."

The FDA staffer pointed to the example of creatinine testing, a common blood test for kidney function. These tests vary wildly from lab to lab, he said. "Why? Because when we cleared them, they can essentially choose which predicate they use. It's really the antithesis of traceability. They just essentially choose one that has as bad evidence as theirs has and makes them look good, and we clear it."

This trend has to change, Gutierrez said.

In addition, he says FDA has allowed companies to use terms in their labeling, such as "sensitivity" (rate of true positives) and "specificity" (rate of true negatives) even when the terms "don't really describe what manufacturers actually proved to us."

"A lot of times, they put in the label 'sensitivity' and 'specificity' and that's really not what they have shown," he said. "They've shown some relative [sensitivity and specificity] or some comparison to that."

FDA is trying to tighten up the way diagnostics manufacturers word claims in their labeling, he said.

Finally, FDA has historically exercised little control over companies' claims of intended use for diagnostic tests, Gutierrez continued.

"Sometimes the intended use is very broad and more analytical than useful," he said at the AACC meeting. "It's very useful when we have an intended use that says what populations were studied, what is known about the device and what its indications for use are."

He said FDA is getting better at better defining and focusing intended use claims, though more work is needed on that front, as well.

- Jessica Bylander

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