Drugs

Gottlieb Steps in to Ease Hospital Product Shortages

FDA commissioner Scott Gottlieb says the agency is taking steps to improve certain drug shortages at hospitals caused by hurricanes that devastated Puerto Rico this summer. Presumably, the agency is reacting to concerns raised late last week by the American Hospital Association, which urged the agency to intervene and “expedite the resolution of the worsening shortages of small-volume parenteral solutions.” To help with the shortages, FDA says it will now:

temporarily allow the importation of IV saline products from facilities outside of the U.S.
encourage the expansion of production at existing facilities to meet shortfalls
expedite its review of new product applications that will help address the shortage.

“For instance, we’re working with one supplier, Baxter, to help them restore operations in their Puerto Rico facilities and move critical ingredients and products onto and off the island,” Gottlieb says. ”Additionally, the FDA recently approved IV solution products from Fresenius Kabi and Laboratorios Grifols. Both companies are expected to increase production of saline products in the coming weeks. We believe steps like these will help to improve the shortage situation over time.”

To learn more about FDA efforts to address product shortages, click here.

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