Drugs

Former NECC Ops Director Sentenced to 5 Months in Jail

Sharon Carter, the former director of operations at the now-defunct New England Compounding Center (NECC), has been sentenced in a Massachusetts federal court to five months in prison, one year of supervised release, and a fine of $4,000 for conspiring to defraud FDA. Carter was the last of the NECC defendants to be sentenced, according to a Department of Justice statement.

The case dates back to 2012 when 753 patients in 20 states were diagnosed with a fungal infection after receiving injections manufactured by NECC that were contaminated with preservative-free methylprednisolone acetate. More than 100 patients died as a result, the statement says.

A criminal investigation found that NECC pharmacists knowingly made and sold numerous drugs in an unsafe manner and in insanitary conditions. It also found that the company repeatedly misrepresented to FDA and the state pharmacy board that NECC was operating as a pharmacy dispensing drugs only for patient-specific prescriptions. In reality, the department says, NECC was shipping drugs in bulk across the nation for over a decade, evading regulatory oversight through fraud and misrepresentation.

“As director of operations,” the statement says, “Carter oversaw the processing and confirmation of drug orders received by NECC. Carter conspired with others to shield NECC’s operations from regulatory oversight by FDA by claiming to be a pharmacy dispensing drugs pursuant to valid, patient-specific prescriptions. In fact, NECC routinely dispensed drugs in bulk without valid prescriptions. Carter directed employees to engage in numerous fraudulent prescription schemes to deceive regulators by creating the appearance that NECC had prescriptions for the drugs it was selling.”

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

Read more

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