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Today, the US Food and Drug Administration sent a warning letter to the Inova (Inova) genome laboratory in Falls Church, Virginia, for illegally marketing certain genetic tests that were not safe and effective. been reviewed by the FDA. The tests claim to predict the response of patients to specific drugs based on genetic variants. The selection or modification of drug treatment in response to test results could have potentially serious consequences for the health of patients. The FDA is not aware of evidence that Inova tests can help patients or health professionals make appropriate treatment decisions for the listed drugs. The actions taken today reflect the agency's commitment to monitor the pharmacogenetic testing landscape and to take appropriate action to address a significant risk to public health.
"Consumers are increasingly adopting genetic testing to better understand their individual risk of developing diseases. With this increase in popularity and availability, we are also seeing a significant activity in the field of pharmacogenetics, which involves understanding the possible role of genetics in a patient's response to a given drug. Without proper evaluation to determine if these tests work, patients are at risk, which can affect treatment decisions by making them a false promise to respond well to a drug or preventing them from occurring. use treatments that could be beneficial to them, "said Jeff Shuren. MD, JD, director of the FDA's Center for Devices and Radiological Health. "We are publishing this warning letter as part of our ongoing efforts to protect the public from the significant risks posed by these tests. We are particularly concerned about pharmacogenetic tests that purport to predict patients' response to specific medications when such claims have not been established and are not described in the drug labeling. We continue to caution patients and health professionals that they should not rely on these tests. treatment decisions. "
"Being able to detect genetic variants and use them to determine appropriate treatment is one of the ways we encourage research and innovation. We have so much more to learn about using these tests for specific medications, about the meaning of the findings and how we can use the information to improve patient health, "said Janet Woodcock, MD, Director of the FDA Center for Drug Evaluation. and research. "We are committed to supporting innovation in this area, but we will be vigilant in protecting against potential risks. As a result, we are issuing this cautionary letter to protect patients and data providers from data that has not been demonstrated to promote safety and security. effective use of medicines. "
The use of certain drugs can be informed by pharmacogenetic tests. When the body has examined the scientific evidence establishing a relationship between the effects of the drug and the genetic variants and determined that the information is sufficient to appear on the label of the drug, information on how to use the results of genetic testing to handle the treatment of the drug are described in the labeling. the specific drug to ensure safe use of the drug.
The FDA has sent a warning letter to Inova for marketing pharmacogenetic tests not reviewed by the FDA that are expected to predict patients' clinical response to specific drugs, including antidepressants, opioids, cancer treatments, anesthesia, and diabetes. The FDA has not reviewed and is not aware of any evidence that Inova's tests can help patients or health professionals use the listed drugs more safely and effectively. The warning letter asks Inova to respond within 15 working days from the date the letter of warning was received, with details of how the violations found in the letter of Warning will be corrected. Any uncorrected breach could result in coercive measures such as seizures, injunctions or monetary penalties.
Tests that make claims that have not been evaluated by the FDA may encourage health care providers and patients to inappropriately select or modify drug treatment based on the results of genetic testing. Acting on these results could have potentially serious consequences for the health of patients. For example, patients may change the dose of their medications for a particular condition or disease based on the results of such a genetic test, which may result in improper treatment or worsening of the disease.
Last year, the agency issued a safety communication warning consumers and health professionals that pharmacogenetic tests were marketed directly to consumers or offered by health care providers claiming to predict how a patient would react to specific drugs.
Following the release of the Safety Communication, the FDA contacted several companies that market pharmacogenetic tests to predict how a person will respond to specific drugs in cases where the relationship between genetic variation (DNA) and the effects of the drug has not been established. Most companies have responded to FDA's concerns by removing specific drug names from their labeling, including promotional materials and patient test reports.
These actions, including the warning letter released today, reflect the agency's commitment to advancing policies that strengthen the FDA's oversight of device safety. As part of the medical device safety action plan, the FDA has warned the public when safety issues are identified, such as thermography devices.
Healthcare professionals and consumers should report any adverse events related to these tests, as well as other genetic tests, to the FDA MedWatch Adverse Events Notification Program. To file a report, use the MedWatch Voluntary Online Report Form. The completed form can be submitted online or by fax at 1-800-FDA-0178. The FDA monitors these reports and takes appropriate measures to ensure the safety of medical products on the market.
The FDA, an agency of the US Department of Health and Social Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety of food products, cosmetics, food supplements, products emitting electronic radiation and the regulation of tobacco products.
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