FDA Warns Against False Pharmacogenetic Claims

April 9, 2019

04/03/2019 MPR

The FDA issued a warning to Inova Genomics Laboratory for the illegal marketing of pharmacogenetic tests for predicting medication response to antidepressants, opioids, cancer therapy, anesthesia, and diabetes treatments.

The warning letter describes how Inova’s MediMap tests are being falsely marketed to predict drug response to aid in making treatment decisions and avoid “trial-and-error prescribing.” In addition, the MediMap Baby test for newborns claims to predict response to 24 drugs to provide guidance in prescribing safer and more effective medications.

According to the FDA, no data are available to establish the validity of these tests for their intended uses. For some drugs, where proper usage can be guided by pharmacogenetic testing, the FDA reviews data showing a relationship between the drug’s effects and genetic variants and includes the information in the drug labeling. Inappropriate selection or modification of treatment based on unapproved genetic tests may cause potentially serious health issues for patients and worsening of the disease.

Read the full MPR story.