Drugs

Learn Drug Shortage Root Causes: Senators

A bipartisan group of 31 senators has written to FDA commissioner Scott Gottlieb asking that the agency’s Drug Shortage Task Force “work with stakeholders and federal agencies to determine the root causes of drug shortages and develop recommendations to ensure that appropriate supplies of essential medicines are always available.” The senators ask that the task force make recommendations to Congress no later than the end of 2019.

The letter commends Gottlieb’s recent statements on agency efforts to mitigate shortages of intravenous drugs, shorten supply disruptions, and better predict vulnerabilities. “We believe the actions you laid out and information you presented are positive steps in addressing drug shortages,” the senators say…. “While important strides have been made since the height of the drug shortage crisis in 2012 and the subsequent enactment of the FDA Safety and Innovation Act, and the number of new shortages reported to FDA per year has decreased over time, the total number of unresolved shortages continues to be problematic to the health system according to FDA’s own data. The damage inflicted upon certain drug manufacturing facilities by Hurricane Maria in 2017 not only exacerbated these existing shortages, but exposed just how fragile our current system is, highlighting the need to take action to improve redundancy and preparedness in our supply chain.”

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