Drugs

Value of FDA Accelerated Approval Not Proven: Researchers

University and Veterans Affairs researchers say their study of Centers for Medicare and Medicaid Services (CMS) spending for drugs that received FDA accelerated approval often found that the approval was not associated with added value relative to existing therapeutic options. The study was published in JAMA Health Forum.

The researchers found that many drugs granted FDA accelerated approval lacked evidence of clinical benefit, even after being converted to standard approval, but they still accounted for a substantial portion of spending by the Centers for Medicare and Medicaid Services (CMS). They performed a cross-sectional study of 38 drugs granted FDA accelerated approval from 2012 to 2017 and found that CMS spent nearly $68 billion through 2020, including $51 billion after conversion to standard approval following confirmatory trial results. However, the researchers say, 59% of the spending was for drugs with confirmatory trials that evaluated surrogate endpoints.

“Although intended to foster earlier access to promising drugs, evidence suggests that the accelerated approval pathway is not associated with added value relative to existing therapeutic options,” the study says. “FDA should continue to review drug sponsors’ compliance with confirmatory trial requirements, enforce its deadlines, and quickly withdraw market authorization for indications that fail to confirm clinical benefit.”

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