James Boiani, Senior Counsel in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Diagnostic Testing Fight Puts FDA in a Pickle." (Read the full version – subscription required.)

Following is an excerpt:

The U.S. Food and Drug Administration is facing pressure to let more diagnostic testing tools be used in doctors' offices, placing regulators in the middle of a feud between device manufacturers eager to boost sales and sophisticated laboratories that stand to lose business. …

Last month, a half-dozen IVD makers launched the Coalition for CLIA Waiver Reform, arguing that a new approach adopted by the FDA in 2008 has proved too strict, preventing foolproof tests from being used at the "point of care" instead of off-site labs and thus making treatments less timely.

"There is sort of a fundamental problem with the way that FDA is interpreting the law today," said James A. Boiani of Epstein Becker Green, which is advocating for the coalition.

Specifically, the coalition and its allies argue that the FDA improperly introduced requirements that go beyond the language of CLIA. The law says waivers are warranted if a test is so straightforward and reliable that faulty results are unlikely to be produced "by the user." …

The American Clinical Laboratory Association, which represents "nonwaived" labs that perform relatively sophisticated testing, issued a statement to Law360 saying that "any changes to [current] requirements should be very carefully studied and considered in the context of patient safety."

"It is important that all tests provided to patients meet certain basic criteria, and this is especially true for point-of-care testing that may not be performed in labs with extensive quality control and highly trained personnel available," the association said. …

Boiani said that rationale was what led the FDA to take a tougher tack in 2008, but that recent scientific advances call for loosening up.

"The technology now exists to make some of these tests even more foolproof and I think mitigate some of the concerns that FDA had," he said.

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