Drugs

Committee Leaders Want FDA Heparin Probe Documents

Four Republican leaders of the House Energy and Commerce Committee have asked FDA for documents relating to two closed Office of Criminal Investigation (OCI) investigations into the 2007-2008 heparin contamination crisis. In a 3/15 letter to FDA acting commissioner Stephen Ostroff, the four say the committee is continuing its examination of the heparin incident “to help improve FDA’s strategy in combating economically-motivated adulteration of medical and food products imported to the U.S.”

The letter asks for all agency documents related to OCI case number 09-TFM-709-0257 and all documents related to an investigation that was spun off from that case. According to the committee leaders, OCI opened the numbered case from information developed during its 2008 heparin investigation and then closed the investigation. “However, OCI opened another investigation spun off from information developed during the 09-TFM-709-0257 case, and conducted this investigation for seven years,” they write. “During a 2/23 committee staff briefing, FDA OCI stated that the OCI case spun off from the 09-TFM-709-0257 investigation was closed as of 11/2016.”

The committee leaders say they have tried for years to obtain documents from FDA and have been consistently turned away because of an open OCI investigation.

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