Drugs

Sentinel Tool Comparable to Protocol-driven Assessment: Study

FDA’s medical product safety surveillance system, Sentinel, has passed the first performance test of its modular program tools as part of a multi-effort assessment to validate their usefulness as surveillance measures. The test was conducted by FDA and other research partners to determine the extent to which a newly developed, semi-automated Sentinel Propensity Score Matching (PSM) tool could produce the same results as a customized protocol-driven assessment. The results were published this month in a journal article in Clinical Pharmacology & Therapeutics.

The researchers examined whether the PSM tool could produce the same results as a more traditional customized protocol-driven assessment, also conducted within Sentinel’s distributed data network, that involved a comparison of angioedema risk between angiotensin-converting enzyme (ACE) inhibitors and beta-blockers. The protocol-driven assessment found an adjusted hazard ratio (HR) of 3.04 comparing angioedema inpatients initiating ACE inhibitors versus beta-blockers, whereas the PSM tool produced a HR of 3.14 by evaluating 2,211,215 eligible ACE inhibitor initiators and 1,673,682 beta-blocker initiators. “This comparison provides initial evidence that Sentinel analytic tools can produce findings similar to those produced by a highly customized protocol-driven assessment,” the researchers say in their article.

“While this is only one example, it demonstrates that the use of a semi-automated analytic tool in the Sentinel distribute database can produce results similar to those of safety assessments that involve de novo programming,” the researchers write. “Results of both the PSM tool analysis and the prior protocol-based assessment are also consistent with previous studies performed in other administrative data sources and using other protocol-driven approaches.”

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