Drugs

Fresenius Kabi Oncology Pleads Guilty in Records Case

Fresenius Kabi Oncology is pleading guilty to concealing and destroying records before a 2013 FDA plant inspection and has agreed to pay $50 million in fines and forfeitures. The Department of Justice says that a criminal information filed in Nevada federal court charges the company with violating the Federal Food, Drug, and Cosmetic Act by failing to provide certain records to FDA investigators. In addition to a $30 million fine and $20 million forfeiture, the company also agreed to implement a compliance and ethics program designed to prevent, detect, and correct violations of U.S. law relating to its manufacturing of cancer drugs for terminal patients.

Court documents show that Fresenius Kabi owned and operated a facility in Kalyani, West Bengal, India, that manufactured active pharmaceutical ingredients (APIs) used in various cancer drugs distributed in the U.S. The government alleges that before a 1/2013 FDA inspection at the facility, plant management directed employees to remove certain records from the premises and delete other records from computers that would have revealed the company was manufacturing APIs in contravention of FDA requirements. Plant employees removed computers, hardcopy documents, and other materials from the premises and deleted spreadsheets that contained evidence of the plant’s violative practices, the Justice Department 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