Drugs

Prior Decisions Should Guide New Drug Reviews: Researchers

Researchers from FDA and Stanford University say the agency has no mechanism to find or tradition to cite similar cases when weighing evidence for drug approvals, resulting in “standalone, bespoke decisions.” Writing in the Annals of Internal Medicines, the researchers say that as a result, FDA’s decisions show highly variable criteria for “substantial evidence” when flexible evidential criteria are used.

“A precedential tradition and suitable information system are required for FDA to improve institutional memory and build upon past decisions,” the authors conclude. “These would increase FDA’s decisional transparency, consistency, and predictability, which are critical to preserving FDA’s most valuable asset, the public’s trust.”

The researchers looked at 912 drug applications submitted between 2013 and 2018, with 117 requiring multiple reviews. Of the 117, 22 were initially rejected because clinical efficacy was deemed inadequate for various reasons, including disagreement between FDA and the applicant about clinical meaningfulness of the findings, inconsistent results, and deficiencies of data integrity or statistical analysis.

Some were approved after submission of new pivotal studies, the report says, and others after clarification of inconsistent results. Eight were approved by an FDA division director despite unresolved issues. Occasionally, it says, approval followed shifting the application to a different FDA division without any change in the evidence.

In a companion report, Joel Perlmutter from the Washington University in St. Louis School of Medicine says the research is an important first step “in trying to demystify the actions of FDA.” He says prospective rules for transparency must be developed and followed. He also says that breaking the “financial tether” between FDA and industry would help ensure independence.

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