Drugs

NE Compounding Center Owner Fights Fraud Claim

A part owner of the New England Compounding Center (NECC) is asking a Massachusetts federal judge to dismiss the only charge against him — fraud on FDA — since the agency has admitted that the law differentiating compounding firms from drug manufacturers was not clear. Gregory Conigliaro is arguing that charging someone with conspiracy to do something that isn’t illegal is a “pure legal impossibility,” according to a Law360 report.

Federal prosecutors have alleged that the NECC positioned itself as a compounding pharmacy, although it actually was a drug manufacturer, depriving FDA of its ability to regulate it. According to prosecutors, the lack of stringent safety standards led to the contamination of steroid injections and an outbreak of fungal meningitis that killed at least 64 people.

Federal judge Richard Stearns said during a March hearing that it was “hard for me to see what FDA was defrauded of.”

When then-FDA commissioner Margaret Hamburg was called to testify before Congress on the NECC incident, she said that the line between drug manufacturers and compounding pharmacies was not entirely clear, Law360 says. “Speaking to the complexity of the issue and the changing, evolving industry overlaid on top of a fragmented and ambiguous legal framework, it is important to understand that this notion of sort of black and white, compounder or manufacturer, you know, it just is trying to fit a square peg into a round hole,” Hamburg testified.

“Since there was no law that differentiated between the two … the government’s claims are based on allegations that people plotted to do something that was not illegal,” Conigliaro said.

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