FDA should have acted sooner to ban unapproved DTC genetic tests, the agency's medical devices director, Jeffrey Shuren told a House hearing after listening to disturbing results from a recent Government Accountability Office investigation. It found misleading information and deceptive marketing practices at several companies marketing the laboratory-developed tests, which have not been tightly regulated by FDA.
In an undercover operation, GAO fictitious consumers received test results that were misleading and of little or no practical use, the investigation concluded. “For example, GAO's donors often received disease risk predictions that varied across the four companies, indicating that identical DNA samples yield contradictory results,” said GAO special investigations director Gregory Kutz.
One DNA donor was told that he was simultaneously at below-average, average, and above-average risk for prostate cancer and hypertension, he said. “GAO also found 10 egregious examples of deceptive marketing, including claims made by four companies that a consumer's DNA could be used to create personalized supplements to cure diseases,” Kutz said.
Two days before the hearing, FDA told a public meeting it convened to discuss the reliability of the tests that it is moving forward with a risk-based approach for providing regulatory oversight.