While an increase in waiver applications is nice, it certainly does not reflect any watershed change for the program, affirms James Boiani, a Washington, D.C.-based attorney at Epstein Becker & Green who has been pushing to reform the CLIA waiver system.
"It's good to see a few more applications coming in this year, and it may have something to do with new performance goals that FDA adopted as part of MDUFA III," Boiani said. "That being said, a lot of problems persist."
Specifically, he explained in an interview that no matter the number of 'waivers by application' in a given year, the data requirements are currently too steep. As a result, many new CLIA waivers are for follow-on assays rather than completely new analytes, he contends.
Boiani heads the recently formed Coalition for CLIA Waiver Reform, which is pushing to reverse FDA's 2008 guidance. The guidance established accuracy thresholds against a gold-standard reference method to support a CLIA waiver, rather than basing the determination on whether tests can be performed equally well in a complex clinical lab and a waived lab, as it had been in the past. …
"Each new analyte [represents] another diagnostic datum point that could be obtained at the point-of-care," Boiani said, "allowing healthcare providers to make more real-time diagnostic and treatment decisions."