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Trade group’s dispute with FDA highlights need to watch for report revisions

Photo: Lori Greig via Flickr

Photo: Lori Greig via Flickr

The nation’s clinical laboratories have pushed back hard against a proposal by U.S. Food and Drug Administration in October 2014 that would regulate laboratory developed tests. More than a year later, the disagreement became more heated when the Association of Molecular Pathology (AMP) accused the FDA of fabricating examples in a November report on LDTs.

In the report, “The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies,” the agency cited 20 examples of problematic LDTs, saying, “…these products may have caused or have caused actual harm to patients.” We covered this report in a blog post earlier this month.

But that’s just the beginning of the story, as Allison Proffitt, editorial director of BioITWorld, found. Continue reading