Drugs

‘Less Rigorous Standards’ in Drug Approvals: Study

Researchers at three universities who evaluated the evidence in 413 studies supporting 37 novel drugs approved by FDA in 2022 say the results “highlight a trend toward less rigorous standards for novel drug approvals that has evolved over the past few decades.” Writing in an open-access JAMA Network Open article, the authors say most of the studies were sponsored by industry and 25% of the results have become publicly available. Only 55% of studies evaluating drugs approved in 2022 were randomized clinical trials, the study says, although most approvals were justified by randomized clinical trial data.

“In contrast to 2016, when four of 20 products (20%) were approved based on a single trial, single studies justified 65% of the 2022 approvals,” the researchers write. “In 2016, 55% of products were approved based on three or more studies, in comparison with 11% in 2022.”

The paper says the 21st Century Cures Act, approved in 2017, gave FDA greater flexibility to apply evidence-based standards for novel drug approvals. “New drug approvals in 2022 appeared to be based on fewer studies than before passage of the 21st Century Cures Act,” the study concludes. “We believe consumers deserve access to the full range of evidence for the drugs they are considering, not just from the selected studies released to the public.”

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