Top Democrats on the House Energy and Commerce Committee are seeking details from Theranos, the Silicon Valley-based blood testing startup that’s come under federal investigation, about the company’s policies and practices.
Both the Food and Drug Administration and the Centers for Medicare and Medicaid Services have been investigating the company, led by Elizabeth Holmes, over the last several months. Federal health regulators have warned that Holmes could be banned from the industry for two years suggesting that the company did not adequately address concerns, though officials have not officially said whether that would occur.
The letter to Holmes comes from Reps. Frank Pallone (D-N.J.), the committee’s ranking member, Diana DeGette (D-Colo.), the ranking member on the Oversight and Investigations Subcommittee, and Rep. Gene Green (D-Texas), the health subcommittee’s ranking member.
They request that the company brief committee staff on how Theranos is working with regulators to bring its California laboratory into compliance, how it will prevent future compliance issues, whether the company is conducting an internal investigation and how the company is working with medical providers and patients that could have been harmed.
“Given Theranos’ disregard for patients safety and its failure to immediately address concerns by federal regulators, we write to request more information about how company policies permitted systemic violations of federal law and how Theranos is working with regulators to address these failures,” they write. “We also request information to better understand the steps Thernaos is taking to correct flawed test results sent to medical professionals and patients.”