Devices

House Democrats Want Theranos Answers

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 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.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome