Drugs

Baxter Paying $18 Million for Sterile Products Charges

The Justice Department says that Baxter Healthcare Corp. has agreed to pay $18.158 million to resolve criminal and civil liability arising from its failure to follow current good manufacturing practice (cGMP) when manufacturing sterile drug products in North Carolina. A department statement says the resolution includes a deferred prosecution agreement and penalties and forfeiture totaling $16 million and a civil False Claims Act settlement with the federal government totaling $2.158 million.

The government filed a criminal information in a North Carolina federal court charging that between 7/2011 and 11/2012, the company introduced adulterated drugs into interstate commerce because it did not follow cGMP when making the products. The statement says that a Baxter employee reported to management the presence of mold on HEPA filters at the firm’s North Cove manufacturing facility clean room, but Baxter continued to manufacture IV solutions in that clean room for months while the filters the employee had identified as moldy remained in place.

“Subsequent testing of the filters following an unannounced FDA inspection revealed several mold species on the filters,” the department says. “There was no evidence of impact on the IV solutions from the mold found on the filters.”

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