Drugs

Fresenius Kabi to Pay $50 Million in FDA Records Case

The Department of Justice says Fresenius Kabi Oncology was sentenced to pay $50 million in fines and forfeiture for concealing and destroying records before a 2013 FDA plant inspection. A department statement says the company agreed to plead guilty to the misdemeanor offense. A Nevada federal judge accepted the company’s plea and ordered it to pay a criminal fine of $30 million, forfeit an additional $20 million, and implement a compliance and ethics program designed to prevent, detect, and correct violations of U.S. law relating to the company’s manufacturing of cancer drugs.

According to court documents, Fresenius Kabi owned and operated a manufacturing facility in Kalyani, West Bengal, India, that manufactured active pharmaceutical ingredients used in various cancer drug products distributed in the U.S. The government says that before the FDA inspection, plant management directed employees to remove certain records from the premises and delete other records from computers that would have revealed that the company was manufacturing drug ingredients in contravention of FDA requirements.

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