CLIA-phites vs. Quality-noids: Who Will Win the LDT Debate?

Can't we all get along? The fight for 
regulatory oversight of lab developed tests 
is far from over.
The FDA’s proposed guidance for laboratory developed tests (LDTs) continues to create conflict between Quality-noids, those in favor of greater FDA oversight, and CLIA-phites, those who are not. Historically, the FDA has exerted little oversight of LDTs (e.g., no premarket review or quality system requirements) but that’s changing, largely because today’s LDTs are far more complex than the LDTs of the past. Both sides agree that more oversight is needed. Which federal agency should provide it, however, has sparked intense controversy.

FDA vs. Centers for Medicare and Medicaid Services (CMS)

The FDA says it has statutory authority to regulate LDTs and will release a final guidance in late 2016/early 2017. Many lawmakers and industry groups disagree. They have proposed an alternate plan: give the authority to the Centers for Medicare and Medicaid Services (CMS) under an expanded CLIA program. Quality and compliance expert Walt Murray, CEO of ARC Experts, says the latter option won’t cut it because the existing CLIA framework does not incorporate risk-based design, manufacturing or supplier controls. Good quality controls are needed, he says, and GxP compliance falls under the purview of the FDA.
“In my experience, finding a happy meeting point between CLIA-phites and Quality-noids can be a pretty daunting task. I’ve been involved with corporate lab clients who have asked, “Walt, can I get a Ph.D. in lab science to digest and implement quality management principles?” My reply was a shaky, “Yes, but only after a frontal lobotomy!”

This article is related to the white paper: 
Managing CLIA Compliance Costs: 6 Mistakes Every Laboratory Should Avoid
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Lab Science and Quality Don’t Always Go Hand-in-Hand

In a recent article featured in Clinical OMICs, a publication of Genetic Engineering & Biotechnology News (GEN), Murray noted that being a CLIA-compliant lab doesn’t guarantee LDT safety and efficacy. His opinion has merit. In 2015, the FDA released a report titled “The public health evidence for FDA oversight of Laboratory Developed Tests: 20 case studies.” The report lists specific examples of LDTs gone bad, and all cases took place in CLIA-compliant labs. It seems unlikely, according to Murray, that the LDTs cited in the report would have survived the FDA’s intense premarket review process.

To read the full article, “How to Address the FDA’s Proposed LDT Framework: Moving From CLIA to QSR,” click here.

Lisa Weeks, a marketing communications specialist at MasterControl, writes extensively about technology, the life sciences, and other regulated environments. Her two decades of marketing and advertising experience include work with McNeil Pharmaceuticals, SAP AG, SCA Mölnlycke, Crozer-Keystone Health Systems, and NovaCare Rehabilitation/Select Med. Her work has appeared in numerous industry publications, including Medical Product Manufacturing NEWS (MPMN), Medtech Pulse, Risk Insights, MD+DI, Pharmaceutical Processing, Genetic Engineering & Biotechnology News (GEN) and PharmaTech.