Posted by Michael Wonder on 01 Nov 2018
Director of the FDA’s Center for Devices and Radiological Health and Director of the FDA’s Center for Drug Evaluation and Research on agency’s warning to consumers about genetic tests that claim to predict patients’ responses to specific medications
1 November 2018 - As a public health agency, one of our key roles is to promote and advance safe and effective medical product innovations. One rapidly advancing, and very promising, area of science and medicine is the field of genetic tests.
Genetic testing can provide helpful information about how an individual’s genes may predispose them to certain diseases and conditions, which may prompt consumers to be more engaged in pursuing the benefits of healthy lifestyle choices and more aware of their health risks.
Consumers are increasingly embracing direct-to-consumer genetic testing to better understand their ancestry or individual risk for developing diseases. Health care providers are using genetic testing to help inform decisions about their patients’ health, health risks and more. Further, we are 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 drugs. The use of some drugs can be aided by pharmacogenetic testing; there is sufficient scientific evidence demonstrating a relationship between certain drugs and genetic variants. For example, the blood thinner clopidogrel (Plavix) has a boxed warning that indicates health care providers should consider an alternative therapy for patients with specific genetic variants.
