Washington, D.C. - Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Ranking Member Gene Green (D-TX) and Oversight and Investigations Subcommittee Ranking Member Diana DeGette (D-CO) today sent a letter to Theranos requesting information on the company’s failure to comply with federal regulatory standards governing clinical laboratory testing and its steps to address flawed test results sent to thousands of medical professionals and patients.
The letter comes after a series of inspections over the last year by both the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) documented serious compliance issues. In one instance, CMS concluded that the violations posed “immediate jeopardy to patient and health safety."
Numerous media outlets have also reported that CMS found Edison, a Theranos blood-testing device, consistently returned inaccurate blood test results for patients on the blood thinner Warfarin. Too much Warfarin can lead to internal bleeding and too little can leave a patient with an increased risk of stroke. Under current law, Theranos was not required to obtain clearance by FDA of its lab developed tests, including those employing its Edison device, before marketing these tests to patients.
“Given Theranos’ disregard for patient safety and its failure to immediately address concerns by federal regulators, we write to request more information about how company policies permitted systematic violations of federal law and how Theranos is working with regulators to address these failures," Pallone, Green, and DeGette wrote. “We also request information to better understand the steps Theranos is taking to correct flawed test results sent to medical professionals and patients."
The Democratic Committee leaders asked that the company provide a briefing to Committee staff in order to address numerous questions, including:
• How is Theranos working with regulators to come into compliance with federal law?
• How has Theranos changed its internal policies to prevent future compliance issues associated with its laboratories?
• What steps is Theranos taking to assist medical professionals and patients who many have been harmed by inaccurate test results?
