Drugs

NECC Co-owner Sentenced to 1 Year Jail Term

Gregory Conigliaro, a former co-owner of now-closed New England Compounding Center (NECC), has been sentenced in Boston federal court to one year in prison for his role in conspiring to defraud FDA. In 2018, Conigliaro was convicted following a 41-day jury trial for his role in the nationwide outbreak of fungal meningitis that was traced back to contaminated vials of preservative-free methylprednisolone acetate manufactured by NECC.

Conigliaro served as NECC general manager and was the primary point of contact with federal and state regulators, according to an FDA release. “Conigliaro conspired with the former co-owner of NECC and head pharmacist, Barry Cadden, and others at NECC to misrepresent to the FDA and the Massachusetts Board of Registration in Pharmacy that NECC was operating as a pharmacy dispensing drugs only pursuant to patient-specific prescriptions, when, in reality, NECC was shipping drugs in bulk across the nation for over a decade, evading regulatory oversight through fraud and misrepresentation,” it says.

“Through this deceit, Conigliaro and NECC were able to avoid the FDA’s oversight authority — and the FDA’s requirement that drug-manufacturers follow cGMPs—and operate in a slipshod, unsafe manner, ultimately leading to a tragic outbreak of fungal meningitis that killed more than one hundred individuals and injured many hundreds more,” FDA 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