Pharmacogenetics: FDA Releases Table of Gene-Drug Interactions

The US Food and Drug Administration (FDA) on Thursday published a table identifying more than 50 gene-drug interactions that the agency says are supported by scientific evidence and announced it is considering new approaches to evaluating pharmacogenetic associations. “Consistent with our mission to protect and promote public health, we believe it is important to take steps now to help ensure that claims being made for pharmacogenetic tests offered today are grounded in sound science to avoid inappropriate management of patients’ medications,” said Center for Devices and Radiological Health Director Jeff Shuren and Center for Drug Evaluation and Research Director Janet Woodcock. The release of the table comes after years of grappling over how FDA should approach pharmacogenetic (PGx) testing and the broader field of laboratory developed tests (LDTs). In 2018, FDA issued a safety communication and statement advising that many genetic tests purporting to predict a patient’s response to medications have not been reviewed by the agency and may not be supported by scientific or clinical evidence.