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# House Democrats Want Theranos Answers
- URL: https://www.fdaweb.com/house-democrats-want-theranos-answers/
- Published: 2016-07-26T12:00:00.000Z
- Updated: 2026-09-14T21:18:05.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136283

Democratic leaders on the House Energy and Commerce Committee are asking FDA and the Centers for Medicare and Medicaid Services (CMS) for information on how regulators are working with Theranos to ensure that the company complies with federal regulatory standards and addresses concerns about its flawed blood test results. [Letters](https://democrats-energycommerce.house.gov/newsroom/press-releases/democratic-committee-leaders-request-information-from-fda-and-cms-on?ref=fdaweb.com) to the two agencies said that “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.” These letters follow one the Democratic committee leaders sent last month to Theranos requesting information on the company’s plan to help medical professionals and patients affected by the flawed results.

FDA 2015 inspections at Theranos laboratories documented a number of significant compliance issues, the letters say. The representatives ask FDA for a briefing covering: 

- an overview of the violations and observations documented in the 2015 FDA inspections of Theranos laboratories in California;
- additional information on inspections or plans to inspect Theranos Arizona laboratories;
- an update on the company’s efforts to work with CMS to comply with federal law; and
- clarification on whether the blood tests marketed by Theranos are under FDA’s enforcement discretion for laboratory-developed tests and whether FDA needs additional authority to ensure that such blood tests are not marketed before the agency finds the test is safe and effective so that healthcare providers and patients can rely on test results when making important medical decisions.