Drugs

Sentinel Moving Slowly Toward Potential: JAMA Article

An analysis in the Journal of the American Medical Association says that FDA’s Sentinel Initiative has moved from a pilot program to being operational, but still has not reached its full potential. While some observers have heralded developments so far as major achievements, the report notes, only a handful of agency safety actions have resulted from Sentinel, and it has not yet become the active drug safety surveillance system many hoped it would be.

“For example,” it says, “the hope by some that Sentinel would be able to flag previously unknown safety problems with drugs hasn’t yet panned out.”

An assessment of the program mandated by the FDA Amendments Act and published 9/2015 found that FDA so far has met or exceeded the targets outlined in that act and the Prescription Drug User Fee Act. However, it also found that use and awareness of the system among agency staff was generally low.

A challenge to fuller utilization of Sentinel is said to be the “very modest funding” that is dedicated to it.

At the time of the interim analysis, Sentinel queries had resulted in no medical product withdrawals or recalls, two label changes, and three safety communications. In many cases, according to the article, Sentinel was used not as the primary source but as an adjunct to other agency tools. Thus, agency officials said that while Sentinel is considered to be a powerful tool, traditional adverse event reporting by doctors, patients, and drug companies remains a primary source of safety information for FDA.

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