Democrats Call on Theranos CEO to Testify About Regulatory Shortcomings, Inaccurate Test Results

Regulatory NewsRegulatory News | 06 July 2016 |  By 

A group of high-ranking House Democrats have launched an inquiry into blood testing startup Theranos over its adherence to clinical laboratory testing standards.

Following inspections last year, the US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) each cited Theranos for a number of compliance issues.

In a letter dated 30 June 2016, Reps. Frank Pallone (D-NJ), Gene Green (D-TX) and Diana DeGette (D-CO) call on Theranos CEO Elizabeth Holmes to brief the House Energy and Commerce Committee on Theranos' response to recent FDA and CMS inspections and revelations that many of the company's tests were inaccurate.

"We are conducting oversight of Theranos' failure to comply with federal regulatory standards covering clinical laboratory testing, and the resulting impact on patients nationwide … 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 issues," the letter states.

A Theranos representative told Focus the company plans to cooperate with the inquiry, saying, "Patient safety and clinical quality are our top priorities. We look forward to answering the members' questions and explaining the significant actions we have taken with new operational leadership and quality standards at our laboratories."

A Democratic aide told Focus the committee is awaiting Theranos' response "before making any decisions about next steps," including the potential for a hearing.

FDA & CMS Inspections

In separate Form 483s, FDA detailed 14 observations concerning two Theranos facilities in Northern California. In its observations, FDA said Theranos' proprietary blood specimen collection device, which the company had been shipping for use in multiple states, required clearance as a Class II device, rather than a Class I exempt device as Theranos had claimed. FDA also cited Theranos over questionable record keeping practices and validation issues.

Following its inspection, CMS said it found serious issues at Theranos' Newark, California laboratory that posed "immediate jeopardy to patient health and safety," including five Clinical Laboratory Improvement Amendments (CLIA) level violations. As a result, CMS threatened sanctions on Theranos, including revoking the company's CLIA certification and banning its owners and operators from running other laboratories for two years. However, CMS has yet to impose any of the sanctions, and, as The Wall Street Journalreports, Theranos is still hoping to avoid them.

In response to CMS' findings, Theranos announced it was voiding two years' worth of test results derived from its proprietary Edison test system, and that it had issued tens of thousands of corrected results to patients.

Congressional Inquiry

Specifically, the representatives say they want Theranos to brief them on what the company has done to address the deficiencies cited by FDA and CMS as a result of their inspections, and what action the company has taken to bring its facilities' up to code.

The representatives also ask whether Theranos has made any internal changes "to prevent future compliance issues," and if the company is conducting an internal investigation into its policies and personnel "to determine the root cause of these widespread compliance failures."

The congressmen then raise a series of questions concerning Theranos' handling of its inaccurate test results.

"What steps is Theranos taking to assist medical professionals and patients who may have been harmed by inaccurate test results?" they ask.

Additionally, the representatives ask whether the inaccurate test results are limited only to tests run on Theranos' Edison devices or whether the company has had to correct inaccurate results from tests run on conventional devices.

And finally, the representatives ask how Theranos came to the conclusion that no patients have been harmed as a result of the inaccurate tests, as well as how it determined that the inaccurate tests represent less than one percent of the tests run by the company. Earlier in the letter, the representatives pointed to a "troubling finding" from the CMS inspection report, which found Theranos sent out inaccurate results for a blood clot test commonly used to guide blood thinner dosage to 81 patients.



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