Molecular Pathologists Say FDA Test Rule Prompts Major Questions

The FDA’s decision to regulate laboratory-developed tests triggers the major questions doctrine because it has vast economic and political significance, a group representing molecular pathologists told a federal court.

The Food and Drug Administration’s final rule giving it explicit power to oversee certain medical tests that come from a single laboratory, known as laboratory-developed tests (LDTs), is a “quintessential” major questions case, the Association for Molecular Pathology and pathologist Michael Laposata wrote in a motion for summary judgment before the US District Court for the Eastern District of Texas.

At issue before the court is whether the FDA acted arbitrarily ...