Drugs

Amarin Proposes Vascepa Case Settlement

Amarin Pharma has submitted to a New York federal court a proposed settlement in its case against FDA over commercial speech about off-label use of its Vascepa. Under the proposal, FDA would agree to be bound by the court’s conclusion at trial that the company may engage in truthful and non-misleading speech promoting off-label Vascepa use to treat patients with persistently high triglycerides. Amarin would bear responsibility in the future for assuring that its communications to doctors on off-label Vascepa use remain truthful and non-misleading.

The proposal would allow the company to submit to FDA up to two proposed communications per calendar year for review to determine if the agency has concerns with them. If FDA has concerns, it would have to contact the company with them within 60 days, and the company would have to provide its response within 45 days. Within 30 days of the company response, FDA would respond with specifics on any remaining dispute. If the parties couldn’t resolve the issue, they could ask the court to step in. This process would be in addition to the procedures generally available for submitting proposed communications to FDA for comment, would apply only to new proposed communications about Vascepa off-label use, and would expire 12/31/20.

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