Drugs

California Appeals Court Reverses Drug Preemption Case

A California Court of Appeals has reversed a lower court ruling that cases claiming that manufacturers of incretin-based drugs failed to warn consumers that the drugs increase the risk of developing pancreatic cancer were preempted. The lower court had agreed with the manufacturers (Amylin Pharmaceuticals for its Byetta, Lilly for its Victoza, and Merck for its Januvia and Janumet) that the plaintiffs’ failure-to-warn claims were preempted by federal law.

But the appeals court said it agreed with the 9^th Circuit Court of Appeals, which heard federal cases on the same issue, that the trial court erroneously interpreted the Supreme Court’s decision in Buckman to preclude consideration of scientific evidence that FDA had not previously evaluated.

The state court said the plaintiffs raised the same two arguments that the federal plaintiffs asserted in their appeal to the 9^th Circuit: (1) the companies failed to present clear evidence that FDA would have rejected a changes being effected application seeking to add a warning for pancreatic cancer, and (2) Buckman does not preclude consideration of the plaintiffs’ new safety evidence.

The state appeals court says it agrees with the 9^th Circuit that Buckman does not preclude consideration of the plaintiffs’ new safety evidence. It sent the case back to the lower court for further proceedings.

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