Drugs

Court Sees Possible FDA Liability in Drug Compounding Case

A Massachusetts federal judge has allowed an argument that FDA acted recklessly in its oversight of the New England Compounding Center (NECC) and thus bears some liability for damages incurred by two medical practices that used contaminated sterile drugs from NECC to go forward. The judge ruled on a motion from the Plaintiffs’ Steering Committee on an affirmative defense offered by the Specialty Surgery Center and Calisher and Associates arguing that several non-party governmental entities including FDA were liable by not properly acting against NECC. The steering committee sought judgment on the pleadings.

The medical practices alleged that FDA acted recklessly because it was aware that NECC had sterility and potency issues as early as 2002 but “failed to take any meaningful and substantive action,” the ruling says. The practices cited a 2006 Warning Letter from FDA to NECC and said that the agency “failed to take any action against NECC after issuing this letter and, thus, proximately caused the alleged injuries.”

The judge ruled that the practices had stated sufficient assertions to create an affirmative defense of comparative fault against FDA under the Tennessee public duty doctrine.

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