Devices

Public Citizen Sues FDA for Seprafilm Petition Answer

Public Citizen is suing FDA to compel the agency to respond to the advocacy group’s 2015 petition asking that Baxter’s Seprafilm Bioresorbable Membrane be banned. Seprafilm is a material used by surgeons during abdominal and pelvic surgery to prevent internal organs from forming fibrous bands of tissue that can block the intestine and cause other post-surgery complications, the suit says.

Public Citizen says that as of its 7/2015 petition, FDA had received more than 500 reports of serious adverse events experienced by patients receiving Seprafilm, including 21 patient deaths following surgery.

The petition called on FDA to withdraw the Seprafilm PMA approval and to initiate a mandatory recall of all remaining Seprafilm devices. It says the steps should be taken because the Seprafilm clinical trials failed to demonstrate conclusively the product’s efficacy in improving any important clinically meaningful endpoint. And it says there is substantial evidence that the product causes serious, sometimes fatal, adverse events, as demonstrated by data from randomized clinical trials, other published scientific literature, and the FDA MAUDE database.

The suit asks the DC federal court to declare that FDA violated the Administrative Procedure Act by failing to act on the petition and to issue an order requiring the agency to respond.

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