Drugs

Compounding Center Sales Head Sentenced

The national sales director for the now-defunct New England Compounding Center (NECC), Robert Ronzio, has been sentenced in Massachusetts federal court to time served in connection with conspiring to defraud FDA. Ronzio pleaded guilty in 2016 and cooperated with the government, testifying at the trials of three other NECC defendants.

A Department of Justice statement says NECC fraudulently held itself out as a pharmacy dispensing drugs under physician-created prescriptions, when it actually operated as a manufacturer distributing drugs in bulk.

The department says the NECC criminal case arose from a 2012 nationwide outbreak of fungal meningitis that was traced to contaminated vials of preservative-free methylprednisolone acetate manufactured by NECC. Some 753 patients in 20 states were diagnosed with a fungal infection after receiving injections of the NECC product and more than 100 patients died as a result. The outbreak was the largest public health crisis ever caused by a contaminated pharmaceutical drug, the statement says.

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