Drugs

New England Compounding Pharmacist Gets 8 Years

The former head pharmacist at New England Compounding Center (NECC) has been sentenced to eight years of imprisonment for his role in the 2012 nationwide fungal meningitis outbreak that killed 64 and caused infections in 793 patients. Glenn Chin (Canton, MA) was also sentenced to two years of supervised release, and forfeiture and restitution (to be determined later), according to a Justice Department release. Late last year, Chin was convicted by a federal jury in Boston of 77 counts, including racketeering, racketeering conspiracy, mail fraud and introduction of misbranded drugs into interstate commerce with the intent to defraud and mislead.

The government contends that Chin manufactured three lots of contaminated methylprednisolone acetate (MPA) or more than 17,000 vials of medication. “In doing so, Chin ignored NECC’s own drug formulation worksheets and standard operating procedures,” it says. “Specifically, he improperly sterilized the MPA, failed to verify the sterilization process, and improperly tested it to ensure sterility. Despite knowing these deficiencies, Chin directed the MPA to be filled into thousands of vials and shipped to NECC customers nationwide. During the fungal meningitis outbreak, the CDC identified 18 different types of fungi from MPA vials and patient samples.”

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