Devices

AdvaMed Exec Defends ‘Breakthrough Devices’ Bill

AdvaMed senior executive vice president for technology and regulatory affairs Janet Trunzo says the Advancing Breakthrough Devices for Patients Act of 2016 “does nothing to lessen FDA’s current rigorous approval standards for breakthrough medical devices and diagnostics, but instead will improve access to potentially life-saving and life-enhancing treatment options for patients who may have no alternatives.” Writing in a letter published by The Hill, Trunzo is responding to a 5/5 Congress Blog post that said the bill would weaken FDA.

“The legislation builds on existing law,” Trunzo says, “which allows for FDA priority review of medical technologies used in the treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions and meet one of four criteria: (1) it is a breakthrough technology; (2) there is no approved alternative; (3) it offers a significant advantage over existing alternatives; or (4) its availability is in the best interest of patients. The legislation clarifies these existing criteria, which have been in FDA statute since 1997, and codifies the process for priority review. It is important to note that FDA alone would determine which products meet the criteria to qualify as ‘breakthrough,’ so it in no way ‘dilutes’ the term as the writer claims. Furthermore, the legislation complements FDA’s Expedited Access for Premarket Approval guidance by establishing this priority review process for breakthrough technologies in statute.”

Trunzo’s defense of the bill concludes that priority review of breakthrough products at FDA is important for providing access to critical therapies, “which is why the legislation has received strong bipartisan support in both the House and Senate, from numerous patient groups, and from FDA as well.”

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