Drugs

NIH Shuts Down Drug Making Operation Due to FDA Findings

The National Institutes of Health Clinical Center has “decommissioned” operations at its Pharmaceutical Development Section (PDS) after “serious manufacturing problems and lack of compliance with standard operating procedures” were uncovered in an FDA inspection last year. Previously, PDS operations were suspended while corrective actions were taken (see earlier story).

PDS made products for certain clinical research studies conducted in the hospital and collaborating facilities. In 4/2015, NIH said two vials of albumin, used for administration of interleukin in experimental studies, were found to have fungal contamination. The vials from the same batch were reportedly administered to six patients; it is not known whether those or other vials were contaminated. The six patients have been notified and are being followed closely.

A 7/29 FDA letter to NIH, which noted that PDS was shutting down, also said that the Intravenous Admixture Unit (IVAU) was moving to an interim space while inspection corrections are made and a new facility is built. IVAU was cited for insanitary conditions, including inadequate separation of the aseptic processing area from the common pharmacy, inadequate segregation of non-hazardous drug operations from hazardous drug operations, and not using a sporicidal disinfection agent in the cleaning and disinfection program for ISO 7 and ISO 5 areas.

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