The U.S. Food and Drug Administration (FDA) is advising genetic testing companies against reporting interactions between DNA findings and drug efficacy or side effects to patients over concerns that the information could cause patients to inappropriately start, stop, or switch medications.
According to Shawn Patrick O’Brien, CEO of genetic testing company Genomind, his and other companies have received informal letters and phone calls from the FDA, expressing concerns that disclosing these gene-drug links “would make a patient stop their medication or move forward with another medication, not properly taper the dose between the two medications, … or have too many side effects because of a quick switch.”
Evidence regarding the influence of certain genetic variants on medications’ effectiveness is mixed. In some cases, the FDA has approved drug labels referencing the influence of DNA on the medication and has even recommended precautions against potential side effects. However, the agency notes that these tests are meant to be ordered and explained by a physician; online ordering systems provide patients with direct access to this information without proper guidance to interpret the results.
Until recently, the pharmacogenetic testing field has faced minimal regulatory scrutiny. The perceived “crackdown” on this industry comes as genetic testing has entered the mainstream. An FDA spokesperson confirmed that the agency also is reviewing the marketing of genetic tests because it is “concerned that pharmacogenetic claims that have not been clinically validated could impact the safe use of drugs.”
The National Institutes of Health is also in discussions with the FDA about how to report genetic information to the nearly 200,000 participants of its “All of Us” research study.