Drugs

Califf Backs Evidence Generation Report

FDA commissioner Robert Califf says “the time is right” to address the post-market evidence generation recommendations in a new Reagan-Udall Foundation report. In the prepared text of a speech to be given to an unidentified group, Califf says the post-market questions “stretch beyond the direct purview of FDA and take us into territory that intersects multiple federal agencies, provider organizations, clinicians, and payers, and patients have much at stake in getting this right. The net result of the fragmentation of responsibility in the post-market phase is that we have no national system to generate the evidence we need to optimize the screening, diagnosis, and treatment among the multitude of medical products on the market. Yet we continue to spend over $4.3 trillion for health outcomes that are inferior to other high-income countries, exemplified by our significantly shorter life expectancy compared with peers.”

If the report’s recommendations were to be implemented effectively, Califf says, it could open evidence generation for nutrition and dietary supplements. “The report is a compilation of practical tactics that have been promoted in previous reports,” he says, “but the comprehensive nature of the 30 recommendations gives us an excellent list from which to reform the system.”

He discusses several of the major recommendations and concludes that while FDA will continue to improve the premarket clinical trial system for medical products, “now is the time to make major renovations to our post-market systems. Technology is no longer our limitation. All of us would benefit from more knowledge of which medical products should be used for which patients and populations at a given point in their clinical journey.”

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