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Regulatory News | 28 July 2016 | By Michael Mezher
A group of high-ranking Democrats sent letters to the heads of the US Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) this week asking them to turn over data from their investigations of blood testing startup Theranos.
"Given Theranos' disregard for patient safety and its failure to immediately address concerns by federal regulators, we write to request more information about how regulators are working with Theranos to address these failures," the representatives state in letters sent to FDA Commissioner Robert Califf and CMS Acting Administrator Andrew Slavitt.
The request is part of an investigation launched by House Energy and Commerce Reps. Frank Pallone (D-NJ), Gene Green (D-TX) and Diana DeGette (D-CO) in June in response to issues uncovered during FDA and CMS inspections.
So far, the fallout from the inspections has been severe. After CMS' November 2015 inspection, Theranos voided two years' worth of test results from its proprietary Edison test system, and earlier this month, the agency revoked Theranos' Clinical Laboratory Improvement Amendments (CLIA) certification and banned Theranos' owners and operators, including CEO Elizabeth Holmes, from running other laboratories for two years.
Theranos also received two Form 483s from FDA for separate inspections of the companies' Northern California facilities, in which the agency said the company's "nanotainer" blood collection device required clearance as a Class II medical device.
Specifically, the representatives say they want to know whether FDA and CMS have inspected Theranos' Arizona site, or if the agencies have plans to do so; whether the company has submitted information for 120 of its tests for FDA approval; and whether FDA plans to enforce regulations for laboratory developed tests for Theranos' products.
The representatives also ask CMS to brief them on Theranos' post-inspection response and on the agency's decision to impose sanctions on the company after determining its response did not provide "a credible allegation of compliance and acceptable evidence of correction for the cited deficiencies."
The representatives call on both agencies to provide their responses by 10 August 2016.
Letter – FDA
Letter - CMS