FDA Cracks Down on Illegal Marketing Practices

Action reflects commitment to monitoring pharma landscape


Earlier this month, the U.S. Food and Drug Administration issued a warning letter to Inova Genomics Laboratory of Falls Church, VA for illegally marketing certain genetic tests that have not been reviewed by the FDA for safety and effectiveness.


The tests claim to predict patients’ responses to specific medications based on genetic variants. Selecting or changing drug treatment in response to the test results could lead to potentially serious health consequences for patients.


The FDA’s action today reflects the agency’s commitment to monitor the pharmacogenetic test landscape and take action when appropriate to address a significant public health risk.


“Consumers are increasingly embracing genetic testing to better understand their individual risk for developing diseases. With this rise in popularity and availability, we’re also seeing significant activity in the field of pharmacogenetics, which is the process of understanding what, if any, role genetics plays in a patient’s reaction to particular drugs. Without appropriate evaluation to determine whether these tests work, patients are being put at risk—potentially impacting treatment decisions by providing false promise that they will respond well to a certain medicine or keeping them from using therapies that may benefit them,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.


Tests that make claims that have not been evaluated by the FDA may influence health care providers and patients to inappropriately select or change drug treatment based on the results from genetic tests.  Acting on these results could lead to potentially serious health consequences for patients.


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