Drugs

WLF Asks Court to Uphold Labeling Preemption

Washington Legal Foundation (WLF) has asked the 9^th Circuit Court of Appeals to affirm a lower court ruling that federal law preempts the plaintiffs’ state law failure-to-warn claim because it was impossible for the drug’s manufacturer to change the drug’s label under federal law. Adams v. Merck Sharp & Dohme Corp. is multi-district litigation (MDL) combining lawsuits by users of incretin-based therapies for Type 2 diabetes. WLF says Novo Nordisk manufactures and markets Victoza (liraglutide) and plaintiffs complained that Victoza’s FDA-approved labeling failed to warn of an increased risk of pancreatic cancer.

In its amicus brief, WLF says the lower MDL court correctly held that the agency’s changes-being-effected regulation allows a manufacturer to change its labeling only when it possesses some newly acquired information. It says in this case no such new information exists and thus the state law claims are preempted.

The WLF brief also argues that the decision should be affirmed because the plaintiffs offered no reliable evidence to establish general causation.

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