Devices

FDA Approval Not Needed for Medicare Coverage: Court

Attorney Michelle Yeary (Dechert) says a Texas federal court recently rejected a whistleblower’s argument that because FDA has not determined the safety and effectiveness of off-label use of biliary stents used in a vascular stenting procedure, Medicare payment claims for the stents were false. Essentially, she writes in an online blog post, “plaintiffs’ theory is a ban on off-label use where government health insurance is involved. Plaintiffs want the court to say that off-label use is across the board ‘not reasonable,’ ‘unnecessary,’ and/or ‘experimental.’”

Yeary says that FDA review of a medical device is not a substitute for an insurance eligibility determination. And of more significance in the decision, she says, lack of FDA approval or clearance for a specific use does not categorically disqualify a device from Medicare coverage. “As we’ve seen time and time again, however, off-label use is often the standard of care,” she writes. “Medicine leads, regulations follow.”

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