Devices

NPR Questions FDA OK for Opioid Withdrawal Device

NPR and Side Effects Public Media say their investigation into Innovative Health Solutions’ Bridge medical device being used for opioid withdrawal found that FDA approved the device indication based on results from a clinical trial that was inaccurately described as a retrospective study. The report says the device had been approved for use in pain management when the company sought the broader indication.

“Researchers working with Innovative Health Solutions … submitted to a medical journal a study that wasn’t what it appeared to be,” NPR says. “The study authors said it was a ‘retrospective study,’ which means they would have simply reviewed existing medical data. But it seems that they instead conducted a clinical trial that skirted FDA rules and ethical norms, using vulnerable people suffering from addiction as test subjects. FDA then relied on the results of the study in making its decision to clear the Bridge for marketing as a treatment for opioid withdrawal.”

In response to questions from NPR and Side Effects, FDA said it cleared the Bridge for use in opioid withdrawal because the study reported in the 3/2017 Journal of Drug and Alcohol Abuse demonstrated “a clinical benefit that outweighs the risk of the device.” The agency told the broadcaster it was reviewing the issues raised by the investigation but gave no indication of what action it might take, if any.

Innovative Health Solutions said that it and the researchers followed FDA rules when the study was conducted. However, NPR reports that such a study would have needed institutional review board oversight and there was none for the Bridge trial.

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