Devices

Device Alternate Reports ‘Inappropriate, Unfair’: Zuckerman

National Center for Health Research president Diana Zuckerman says an FDA decision to allow some medical device manufacturers to submit summary reports of adverse events through a hidden Alternate Summary Reporting database was “very inappropriate and unfair to patients and physicians.” As reported online by Cancer Therapy Advisor, Zuckerman said FDA’s position that it implemented the alternate reporting program for adverse events that were already well known does not hold up.

“The justification does not make sense,” she said. “Because while it would make sense to say that FDA thought having summary information would be less burdensome for everyone, including FDA, that doesn’t explain why the information was also not public.”

Former FDAer David Gortler told the online service that he wished FDA had made the hidden reports public sooner.

Cancer Therapy Advisor says the breast implant data from the file that FDA has now published includes more than 4,000 events related to Allergen implants, more than 2,440 events for Mentor products, and more than 140 events linked to Sientra implants.

Zuckerman said that although patients and doctors know that adverse events happen, understanding how frequently they occur is important. “Having that information public is the only way that patients, doctors, or researchers are able to gather information about how often this happens,” she said. “…The bottom line is, the more information we have about medical devices, the more we as health professionals, or we as patients, can make informed decisions.”

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