Biologics

Additional FMT Safety Protections Needed: FDA

FDA says it has determined that additional safety protections are needed for any investigational use of fecal microbiota for transplantation (FMT), whether under an IND on file with the agency or FDA’s enforcement discretion policy. A 4/6 announcement about the recommended new safety steps follows a 3/12 announcement about the potential risk of serious or life-threatening infections with the use of FMT. The agency said it suspected the infections were due to the transmission of pathogenic organisms from FMT products supplied by a U.S.-based stool bank company. The company later identified itself as OpenBiome, Cambridge, MA.

FDA says it has communicated with OpenBiome and individually with IND holders for investigational FMT to underscore the need for these additional protections:

testing FMT donor stool by nucleic acid amplification tests (NAAT) for enteropathogenic Escherichia coli (EPEC) and Shigatoxin-producing Escherichia coli (STEC) to exclude the use of stool that tests positive for either EPEC or STEC; and
testing all FMT products currently in storage for which the donor has not undergone stool testing for both EPEC and STEC using NAAT.

The notice says that patients considering FMT to treat C. difficile should speak to their healthcare provider to understand the potential risks associated with the product’s use.

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