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Democratic Committee Leaders Request Information from FDA and CMS on Theranos’ Inaccurate Blood Tests

Jul 26, 2016
Press Release

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 letters to the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) requesting information about how regulators are working with Theranos to ensure the company complies with federal regulatory standards and addresses concerns about its flawed blood test results that impacted thousands of 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 regulators are working with Theranos to address these failures,” Pallone, Green, and DeGette wrote.

The letters for FDA and CMS follow a letter the Democratic Committee leaders sent to Theranos earlier this month requesting information on the company’s plan to help medical professionals and patients affected by the flawed results.

Inspections of Theranos laboratories by CMS and the FDA in 2015 resulted in discoveries of a number of serious compliance failures. FDA inspections of two laboratories in August and September 2015 found the use of an unapproved medical device, recordkeeping failures, and a failure to conduct quality audits, among other issues. Following a November 2015 inspection of the company’s Newark, California facility, CMS concluded that Theranos’ was in violation of five quality requirements and requested that the laboratory “take immediate action to remove the jeopardy and bring any unmet condition-level requirements into compliance” within 10 calendar days. CMS stated that some of these compliance failures “pose immediate jeopardy to patient health and safety.” After the company failed to take steps to address cited compliance violations, CMS announced in July 2016 it will impose a number of sanctions against Theranos, including barring the company’s chief executive, Elizabeth Holmes, from owning and operating a medical laboratory for at least two years. 

Given the ongoing concerns about Theranos’ compliance with regulatory federal standards and the accuracy of Theranos’ blood tests, the Democratic Committee leaders requested that the agencies provide a briefing to Committee staff on numerous issues, including:

  • An overview of the violations and observations documented in the agencies’ 2015 inspections of Theranos’ California laboratories.
  • Additional information regarding the agencies’ inspections of or plan to inspect Theranos’ laboratories located in Arizona.
  • An update on Theranos’ efforts to work with CMS to come into compliance with federal law.
  • Clarification on whether the blood tests marketed by Theranos are under the FDA’s enforcement discretion policy for laboratory developed tests and if FDA needs additional authority to ensure that such blood tests are not marketed before FDA finds the test is safe and effective so that health care providers and patients can rely on test results when making important medical decisions.

A copy of the letter sent to the FDA is available here and a copy of the letter sent to the CMS is available here.