Laboratory Developed Tests (LDTs) are back in the FDA’s enforcement crosshairs. This time the target is marketing claims related to the medication predictive qualities of pharmacogenetics (PGx) tests that have not received premarket clearance or approval. The FDA’s PGx Concerns PGx tests can be used to detect genetic variants associated with responses to specific medications, e.g., genes that code for drug-metabolizing enzymes or drug targets, explains Steven Tjoe, an attorney with Goodwin Procter LLP in Washington, D.C., and former regulatory counsel in FDA’s Center for Devices and Radiological Health. PGx test results can inform medication decisions such as drug effectiveness and dosage amounts. The FDA’s beef, Tjoe explains, is with claims about the capabilities of unreviewed PGx tests to predict response to specific medications. Thus, on Nov. 1, 2018, the FDA issued a Safety Communication to alert patients and physicians that such claims may not be supported by sufficient scientific or clinical evidence. The FDA cites genetic tests purporting to be capable of predicting whether certain medications used to treat depression may be less effective or have an increased chance of side effects. The relationship between variations and the effectiveness of antidepressant medication has never been established, the Safety Communication […]