Drugs

9th Circuit Denies Gilead FCA Case Rehearing

The 9^th Circuit Court of Appeals has denied a Gilead request to rehear or rehear with the entire court a whistleblower case involving three of the company’s HIV drugs that was initially thrown out by a California federal court, but then was granted by the appeals court. The company’s request for a rehearing was supported by the Washington Legal Foundation (WLF), which announced the appeals court’s refusal.

WLF said its brief had argued that the initial appeals court decision adopted an overly lenient “materiality” standard for False Claims Act cases, facilitating the filing of unwarranted claims against government contractors.

Gilead has said that the whistleblowers’ complaint alleged that the company sold the government drugs representing them as approved by FDA although, according to the whistleblowers, they failed to meet certain manufacturing standards.

“But they were FDA approved and still are to this day,” the company said. “Even after multiple inspections, audits, and investigations, FDA has never withdrawn approval. The government purchasers were also unfazed. Far from seeking refunds when the allegations came to light, the government purchasers continued buying drugs from Gilead year after year.”

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