Without appropriate evaluation ans supporting study data to determine whether genetic 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 otherwise may benefit them. There exists particular concern about pharmacogenetic tests that claim to predict patients’ responses to specific medications where such claims have not been established, are not described in the drug labeling, and/or do not mandatorily recommend that patients (or consumers for that matter) do consult with there treating physicians and genetic counsellors before taking decisions on treatments or life style based on genetic test results only.
This is the real danger of the current frenzy on direct-to-consumer genetic testing (DTCGT) or direct to consumer theragenomic testing (DTCTT) for consumers, patients, and health care providers alike. To be able to detect genetic variants and use them in determining an appropriate course of care is one way in which genetic research and innovation progresses. However, there remains so much more to learn about the use of emerging genetic tests that come out of this research for specific medications, what the results mean, and how the information can applied to improve a patient’s health.
The action taken bs the FDA in this particular case, including the warning letter issued to Inova, reflect and address the FDA’s commitment to advance policies that enhance 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 with thermography devices. Also, last year, the FDA issued a safety communication warning consumers and health care professionals about pharmacogenetic tests being marketed directly to consumers or offered through health care providers that claim to predict how a patient will respond to specific medications. Following the issuance of this latter safety communication, the FDA reached out to several firms marketing pharmacogenetic tests with claims to predict how a person will respond to specific medications in cases where the relationship between genetic (DNA) variations and the medication’s effects has not been established. Most firms addressed the FDA’s concerns by removing specific medication names from their labeling, including promotional material and patient test reports.
Just as in the case of adverse effects of drugs, health care professionals and consumers should report any adverse events related to these and other genetic tests to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178. The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.